8-134.......................  ............................  ASTM F2082-06 Standard Test   Extent of recognition.
                                                             Method for Determination of
                                                             Transformation Temperature
                                                             of Nickel-Titanium Shape
                                                             Memory Alloys by Bend and
                                                             Free Recovery.
8-135.......................  ............................  ASTM F2392-04 (Reapproved     Extent of recognition.
                                                             2010) Standard Test Method
                                                             for Burst Strength of
                                                             Surgical Sealants.
8-136.......................  ............................  ASTM F2458-05 (Reapproved     Extent of recognition.
                                                             2010) Standard Test Method
                                                             for Wound Closure Strength
                                                             of Tissue Adhesives and
                                                             Sealants.
8-150.......................  ............................  ISO 5832-9 Second edition     Extent of recognition.
                                                             2007-06-15 Implants for
                                                             surgery--Metallic
                                                             materials--Part 9: Wrought
                                                             high nitrogen stainless
                                                             steel.
8-157.......................  ............................  ISO 9583 First edition 1993-  Extent of recognition.
                                                             10-15 Implants for surgery--
                                                             Non-destructive testing--
                                                             Liquid penetrant inspection
                                                             of metallic surgical
                                                             implants.
8-159.......................  ............................  ISO 9584 First edition 1993-  Extent of recognition.
                                                             10-15 Implants for surgery--
                                                             Non-destructive testing--
                                                             Radiographic examination of
                                                             cast metallic surgical
                                                             implants.
8-165.......................  ............................  ASTM F1058-08[egr]1 Standard  Extent of recognition.
                                                             Specification for Wrought
                                                             40 Cobalt-20 Chromium-16
                                                             Iron-15 Nickel-7 Molybdenum
                                                             Alloy Wire and Strip for
                                                             Surgical Implant
                                                             Applications (UNS R30003
                                                             and UNS R30008).
8-167.......................  ............................  ASTM F1350-08 Standard        Extent of recognition.
                                                             Specification for Wrought
                                                             18 Chromium-14 Nickel-2.5
                                                             Molybdenum Stainless Steel
                                                             Surgical Fixation Wire (UNS
                                                             S31673).
8-168.......................  ............................  ASTM F1472-08[egr]1 Standard  Extent of recognition.
                                                             Specification for Wrought
                                                             Titanium-6 Aluminum-4
                                                             Vanadium Alloy for Surgical
                                                             Implant Applications (UNS
                                                             R56400).
8-170.......................  ............................  ASTM F961-08 Standard         Extent of recognition.
                                                             Specification for 35 Cobalt-
                                                             35 Nickel-20 Chromium-10
                                                             Molybdenum Alloy Forgings
                                                             for Surgical Implants (UNS
                                                             R30035).
8-171.......................  ............................  ASTM F1609-08 Standard        Extent of recognition.
                                                             Specification for Calcium
                                                             Phosphate Coatings for
                                                             Implantable Materials.
8-173.......................  ............................  ASTM F601-03 (Reapproved      Extent of recognition.
                                                             2008) Standard Practice for
                                                             Fluorescent Penetrant
                                                             Inspection of Metallic
                                                             Surgical Implants.
8-177.......................  ............................  ASTM F2129-08 Standard Test   Extent of recognition.
                                                             Method for Conducting
                                                             Cyclic Potentiodynamic
                                                             Polarization Measurements
                                                             to Determine the Corrosion
                                                             Susceptibility of Small
                                                             Implant Devices.
8-179.......................  ............................  ASTM F754-08 Standard         Extent of recognition.
                                                             Specification for
                                                             Implantable
                                                             Polytetrafluoroethylene
                                                             (PTFE) Sheet, Tube, and Rod
                                                             Shapes Fabricated from
                                                             Granular Molding Powders.
8-183.......................  ............................  ASTM F560-08 Standard         Extent of recognition.
                                                             Specification for Unalloyed
                                                             Tantalum for Surgical
                                                             Implant Applications (UNS
                                                             R05200, UNS R05400).
8-184.......................  ............................  ASTM F2516-07[egr]2 Standard  Extent of recognition.
                                                             Test Method for Tension
                                                             Testing of Nickel-Titanium
                                                             Superelastic Materials.
8-185.......................  ............................  ASTM F451-08 Standard         Extent of recognition.
                                                             Specification for Acrylic
                                                             Bone Cement.
8-187.......................  ............................  ISO 13779-1 Second edition    Extent of recognition.
                                                             2008-10-01 Implants for
                                                             surgery--Hydroxyapatite--Pa
                                                             rt 1: Ceramic
                                                             hydroxyapatite.
8-188.......................  ............................  ISO 13779-2 Second edition    Extent of recognition.
                                                             2008-10-01 Implants for
                                                             surgery--Hydroxyapatite--Pa
                                                             rt 2: Coatings of
                                                             hydroxyapatite.
8-189.......................  ............................  ASTM F 1108-04 (Reapproved    Extent of recognition.
                                                             2009) Standard
                                                             Specification for Titanium-
                                                             6 Aluminum-4 Vanadium Alloy
                                                             Castings for Surgical
                                                             Implants (UNS R56406).
8-190.......................  ............................  ASTM F 90-09 Standard         Extent of recognition.
                                                             Specification for Wrought
                                                             Cobalt-20 Chromium-15
                                                             Tungsten-10 Nickel Alloy
                                                             for Surgical Implant
                                                             Applications (UNS R30605).
8-192.......................  ............................  ASTM F1854-09 Standard Test   Extent of recognition.
                                                             Method for Stereological
                                                             Evaluation of Porous
                                                             Coatings on Medical
                                                             Implants.
8-193.......................  ............................  ASTM F2754/F 2754M-09         Extent of recognition.
                                                             Standard Test Method for
                                                             Measurement of Camber,
                                                             Cast, Helix and Direction
                                                             of Helix of Coiled Wire.
8-194.......................  ............................  ISO 6474-1 First edition      Extent of recognition.
                                                             2010-02-15 Implants for
                                                             surgery--Ceramic materials--
                                                             Part 1: Ceramic materials
                                                             based on high purity
                                                             alumina.
8-195.......................  ............................  ASTM F2024-10 Standard        Extent of recognition.
                                                             Practice for X-Ray
                                                             Diffraction Determination
                                                             of Phase Content of Plasma-
                                                             Sprayed Hydroxyapatite
                                                             Coatings.
8-199.......................  ............................  ASTM F2633-07 Standard        Extent of recognition.
                                                             Specification for Wrought
                                                             Seamless Nickel-Titanium
                                                             Shape Memory Alloy Tube for
                                                             Medical Devices and
                                                             Surgical Implants.
8-204.......................  ............................  ASTM F2118-10 Standard Test   Extent of recognition.
                                                             Method for Constant
                                                             Amplitude of Force
                                                             Controlled Fatigue Testing
                                                             of Acrylic Bone Cement
                                                             Materials.
8-205.......................  ............................  ASTM F1635-11 Standard Test   Extent of recognition.
                                                             Method for In Vitro
                                                             Degradation Testing of
                                                             Hydrolytically Degradable
                                                             Polymer Resins and
                                                             Fabricated Forms for
                                                             Surgical Implants.

8-206.......................  ............................  ASTM F688-10 Standard         Extent of recognition.
                                                             Specification for Wrought
                                                             Cobalt-35 Nickel-20
                                                             Chromium-10 Molybdenum
                                                             Alloy Plate, Sheet, and
                                                             Foil for Surgical Implants
                                                             (UNS R30035).
8-207.......................  ............................  ASTM F1926/F1926M-10          Extent of recognition.
                                                             Standard Test Method for
                                                             Evaluation of the
                                                             Environmental Stability of
                                                             Calcium Phosphate Granules,
                                                             Fabricated Forms, and
                                                             Coatings.
8-213.......................  ............................  ISO 5834-3 First edition      Extent of recognition.
                                                             2005-07-15 Implants for
                                                             surgery--Ultra-high-
                                                             molecular-weight
                                                             polyethylene--Part 3:
                                                             Accelerated ageing methods.
8-214.......................  ............................  ISO 5834-4 First edition      Extent of recognition.
                                                             2005-05-01 Implants for
                                                             surgery--Ultra-high-
                                                             molecular-weight
                                                             polyethylene--Part 4:
                                                             Oxidation index measurement
                                                             method.
8-215.......................  ............................  ISO 5834-5 First edition      Extent of recognition.
                                                             2005-06-01 Implants for
                                                             surgery--Ultra-high-
                                                             molecular-weight
                                                             polyethylene--Part 5:
                                                             Morphology assessment
                                                             method.
8-216.......................  ............................  ASTM F1295-11 Standard        Extent of recognition.
                                                             Specification for Wrought
                                                             Titanium-6 Aluminum-7
                                                             Niobium Alloy for Surgical
                                                             Implant Applications (UNS
                                                             R56700).
8-217.......................  ............................  ASTM F620-11 Standard         Extent of recognition.
                                                             Specification for Alpha
                                                             Plus Beta Titanium Alloy
                                                             Forgings for Surgical
                                                             Implants.
8-218.......................  ............................  ASTM F799-11 Standard         Extent of recognition.
                                                             Specification for Cobalt-28
                                                             Chromium-6 Molybdenum Alloy
                                                             Forgings for Surgical
                                                             Implants (UNS R31537,
                                                             R31538, R31539).
8-220.......................  ............................  ASTM F629-11 Standard         Extent of recognition.
                                                             Practice for Radiography of
                                                             Cast Metallic Surgical
                                                             Implants.
8-221.......................  ............................  ASTM F2066-11 Standard        Extent of recognition.
                                                             Specification for Wrought
                                                             Titanium-15 Molybdenum
                                                             Alloy for Surgical Implant
                                                             Applications (UNS R58150).
8-224.......................  ............................  ASTM F2102-06[egr]1 Standard  Extent of recognition.
                                                             Guide for Evaluating the
                                                             Extent of Oxidation in
                                                             Ultra-High-Molecular-Weight
                                                             Polyethylene Fabricated
                                                             Forms Intended for Surgical
                                                             Implants.
8-225.......................  ............................  ASTM F2003-02 (Reapproved     Extent of recognition.
                                                             2008) Standard Practice for
                                                             Accelerated Aging of Ultra-
                                                             High Molecular Weight
                                                             Polyethylene after Gamma
                                                             Irradiation in Air.
8-226.......................  ............................  ASTM F603-12 Standard         Extent of recognition.
                                                             Specification for High-
                                                             Purity Dense Aluminum Oxide
                                                             for Medical Application.
8-229.......................  ............................  ASTM F75-12 Standard          Extent of recognition.
                                                             Specification for Cobalt-28
                                                             Chromium-6 Molybdenum Alloy
                                                             Castings and Casting Alloy
                                                             for Surgical Implants (UNS
                                                             R30075).
8-330.......................  ............................  ASTM F1978-12 Standard Test   Extent of recognition.
                                                             Method for Measuring
                                                             Abrasion Resistance of
                                                             Metallic Thermal Spray
                                                             Coatings by Using the Taber
                                                             Abraser.
8-331.......................  ............................  ASTM F1580-12 Standard        Extent of recognition.
                                                             Specification for Titanium
                                                             and Titanium-6 Aluminum-4
                                                             Vanadium Alloy Powders for
                                                             Coatings of Surgical
                                                             Implants.
8-333.......................  ............................  ASTM F2393-12 Standard        Extent of recognition.
                                                             Specification for High-
                                                             Purity Dense Magnesia
                                                             Partially Stabilized
                                                             Zirconia (Mg-PSZ) for
                                                             Surgical Implant
                                                             Applications.
8-334.......................  ............................  ASTM F2459-12 Standard Test   Extent of recognition.
                                                             Method for Extracting
                                                             Residue from Metallic
                                                             Medical Components and
                                                             Quantifying via Gravimetric
                                                             Analysis.
----------------------------------------------------------------------------------------------------------------
                                                I. Nanotechnology
----------------------------------------------------------------------------------------------------------------
18-1........................  ............................  ASTM E2490-09 Standard Guide  Extent of recognition.
                                                             for Measurement of Particle
                                                             Size Distribution of
                                                             Nanomaterials in Suspension
                                                             by Photon Correlation
                                                             Spectroscopy (PCS).
18-2........................  ............................  ASTM E2535-07 (Reapproved     Reaffirmation and
                                                             2013) Standard Guide for      extent of
                                                             Handling Unbound Engineered   recognition.
                                                             Nanoscale Particles in
                                                             Occupational Settings.
----------------------------------------------------------------------------------------------------------------
                                                  J. Neurology
----------------------------------------------------------------------------------------------------------------
17-3........................  17-12.......................  ISO 7197 Third edition 2006-  Withdrawn and replaced
                                                             06-01 Neurosurgical           with newer version
                                                             Implants--Sterile, single-    including technical
                                                             use hydrocephalus shunts      corrigendum.
                                                             and components [Including
                                                             TECHNICAL CORRIGENDUM 1
                                                             (2007)].
17-7........................  ............................  ISO 7197: 2006 Neurosurgical  Withdrawn. See 17-12.
                                                             implants--Sterile, single-
                                                             use hydrocephalus shunts
                                                             and components TECHNICAL
                                                             CORRIGENDUM 1.
17-1........................  ............................  ANSI/AAMI NS28:1988/(R) 2010  Extent of recognition.
                                                             Intracranial pressure
                                                             monitoring devices.

17-4........................  ............................  ASTM F647-94 (Reapproved      Extent of recognition.
                                                             2006) Standard Practice for
                                                             Evaluating and Specifying
                                                             Implantable Shunt
                                                             Assemblies for
                                                             Neurosurgical Application.
17-9........................  ............................  ASTM F2129-08 Standard Test   Extent of recognition.
                                                             Method for Conducting
                                                             Cyclic Potentiodynamic
                                                             Polarization Measurements
                                                             to Determine the Corrosion
                                                             Susceptibility of Small
                                                             Implant Devices.
----------------------------------------------------------------------------------------------------------------
                                       K. OB-GYN/Gastroenterology/Urology
----------------------------------------------------------------------------------------------------------------
9-34........................  9-82........................  ISO 4074 First edition 2002-  Withdrawn and replaced
                                                             02-15 Corrected version       with newer version
                                                             2002-12-01 Natural latex      including technical
                                                             rubber condoms--              corrigendum.
                                                             Requirements and test
                                                             methods [Including
                                                             TECHNICAL CORRIGENDUM 1
                                                             (2002), TECHNICAL
                                                             CORRIGENDUM 2 (2002)].
9-57........................  ............................  ISO 4074:2002 TECHNICAL       Withdrawn. See 9-82.
                                                             CORRIGENDUM 2, Natural
                                                             latex rubber condoms--
                                                             Requirements and test
                                                             methods TECHNICAL
                                                             CORRIGENDUM 2.
9-75........................  9-84........................  ISO 8600-3 First edition      Withdrawn and replaced
                                                             1997-07-01 Optics and         with newer version
                                                             Optical instruments--         including amendment.
                                                             Medical endoscopes and
                                                             endoscopic accessories--
                                                             Part 3: Determination of
                                                             field of view and direction
                                                             of view of endoscopes with
                                                             optics [Including AMENDMENT
                                                             1 (2003)].
9-36........................  9-90........................  ISO 8009 First edition 2004-  Withdrawn and replaced
                                                             10-01 Mechanical              with newer version
                                                             contraceptives--Reusable      including amendment.
                                                             natural and silicone rubber
                                                             contraceptive diaphragms--
                                                             Requirements and tests
                                                             [Including AMENDMENT
                                                             1(2012)].
9-37........................  9-83........................  ISO 8600-1 Third edition      Withdrawn and replaced
                                                             2013-03-01 Endoscopes--       with newer version.
                                                             Medical endoscopes and
                                                             endotherapy devices--Part
                                                             1: General requirements.
9-38........................  ............................  ISO 8600-3 First edition      Withdrawn. See 9-84.
                                                             1997-07-01 AMENDMENT 1,
                                                             Optics and optical
                                                             instruments--Medical
                                                             endoscopes and endoscopic
                                                             accessories Part 3:
                                                             Determination of field of
                                                             view and direction of view
                                                             of endoscopes with optics.
9-44........................  ............................  ASTM F623-99 (Reapproved      Extent of recognition.
                                                             2006) Standard Performance
                                                             Specification for Foley
                                                             Catheter.
9-54........................  9-85........................  ASTM D6976-13 Standard        Withdrawn and replaced
                                                             Specification for Rubber      with a newer version.
                                                             Contraceptives--Vaginal
                                                             Diaphragms.
9-56........................  ............................  ASTM D3492-08 Standard        Extent of recognition.
                                                             Specification for Rubber
                                                             Contraceptives (Male
                                                             Condoms).
9-65........................  9-91........................  ANSI/AAMI/ISO 8637:2010       Withdrawn and replaced
                                                             Cardiovascular implants and   with newer version
                                                             extracorporeal systems--      including amendment.
                                                             Hemodialyzers,
                                                             hemodiafilters,
                                                             hemofilters, and
                                                             hemoconcentrators
                                                             [Including AMENDMENT 1
                                                             (2013)].
9-66........................  ............................  ANSI/AAMI/ISO 8638:2010       Extent of recognition.
                                                             Cardiovascular implants and
                                                             Extracorporeal blood
                                                             circuit for hemodialyzers,
                                                             hemodiafilters, and
                                                             hemofilters.
9-67........................  ............................  ASTM D7661-10 Standard Test   Extent of recognition.
                                                             Method for Determining
                                                             Compatibility of Personal
                                                             Lubricants with Natural
                                                             Rubber Latex Condoms.
9-68........................  ............................  ISO 23409 First edition 2011- Extent of recognition.
                                                             02-15 Male Condoms--
                                                             Requirements and test
                                                             methods for condoms made
                                                             from synthetic materials.
9-73........................  ............................  ANSI/AAMI/ISO 13958:2009      Extent of recognition.
                                                             Concentrates for
                                                             hemodialysis and related
                                                             therapies.
9-74........................  ............................  ISO 13958 Second edition      Extent of recognition.
                                                             2009-04-15 Concentrates for
                                                             haemodialysis and related
                                                             therapies.
9-79........................  ............................  ISO 26722 First edition 2009- Extent of recognition.
                                                             04-15 Water treatment
                                                             equipment for haemodialysis
                                                             applications and related
                                                             therapies.
----------------------------------------------------------------------------------------------------------------
                                                  L. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-41.......................  10-81.......................  ISO 11979-7 Second edition    Withdrawn and replaced
                                                             2006-05-01 Ophthalmic         with newer version
                                                             implants--Intraocular         including amendment.
                                                             lenses--Part 7: Clinical
                                                             investigations [Including
                                                             Amendment 1:2012].
10-75.......................  ............................  ISO 11979-7/Amendment 1:2012  Withdrawn. See 10-81.
                                                             Ophthalmic implants--
                                                             Intraocular lenses--Part 7:
                                                             Clinical investigations.
10-42.......................  10-82.......................  ISO 11979-2 First edition     Withdrawn and replaced
                                                             1999-12-15 Ophthalmic         with newer version
                                                             implants--Intraocular         including technical
                                                             lenses--Part 2: Optical       corrigendum.
                                                             properties and test methods
                                                             [Including TECHNICAL
                                                             CORRIGENDUM 1 (2003)].
10-53.......................  10-83.......................  ISO 18369-1 First edition     Withdrawn and replaced
                                                             2006-08-15 Ophthalmic         with newer version
                                                             optics--Contact lenses--      including amendment.
                                                             Part 1: Vocabulary,
                                                             classification system and
                                                             recommendations for
                                                             labeling specifications
                                                             [Including AMENDMENT 1
                                                             2009].

10-61.......................  ............................  ISO 18369-1:2006 Ophthalmic   Withdrawn. See 10-83.
                                                             optics--Contact lenses Part
                                                             1: Vocabulary,
                                                             classification system and
                                                             recommendations for
                                                             labeling specifications.
                                                             ISO 18369-1 First edition
                                                             2006-08-05 AMENDMENT 1 2009-
                                                             02-15.
10-58.......................  10-84.......................  ANSI Z80.11-2012 American     Withdrawn and replaced
                                                             National Standard for         with newer version.
                                                             Ophthalmics--Laser Systems
                                                             for Corneal Reshaping.
10-59.......................  10-85.......................  ISO 11980 Third edition 2012- Withdrawn and replaced
                                                             11-15 Corrected version       with newer version.
                                                             2013-12-01 Ophthalmic
                                                             optics--Contact lenses and
                                                             contact lens care products--
                                                             Guidance for clinical
                                                             investigations.
10-71.......................  10-86.......................  ISO 14729 First edition 2001- Withdrawn and replaced
                                                             04-15 Ophthalmic optics--     with newer version
                                                             Contact lens care products--  including amendment.
                                                             Microbiological
                                                             requirements and test
                                                             methods for products and
                                                             regimens for hygienic
                                                             management of contact
                                                             lenses [Including:
                                                             AMENDMENT 1 2010].
10-43.......................  ............................  ISO 11979-8 Second edition    Extent of recognition.
                                                             2006-07-01 Ophthalmic
                                                             implants--Intraocular
                                                             lenses--Part 8: Fundamental
                                                             requirements.
10-54.......................  ............................  ISO 18369-4 First edition     Extent of recognition.
                                                             2006-08-15 Ophthalmic
                                                             optics--contact lenses--
                                                             Part 4: Physicochemical
                                                             properties of contact lens
                                                             materials.
10-55.......................  ............................  ISO 11979-6 Second edition    Extent of recognition.
                                                             2007-07-15 Ophthalmic
                                                             implants--Intraocular
                                                             lenses--Part 6: Shelf-life
                                                             and transport stability.
10-56.......................  ............................  ANSI Z80.12-2007 (R2012)      Reaffirmation and
                                                             American National Standard    extent of
                                                             for Ophthalmics--Multifocal   recognition.
                                                             Intraocular Lenses.
10-57.......................  ............................  ANSI Z80.13-2007 (R2012)      Reaffirmation and
                                                             American National Standard    extent of
                                                             for Ophthalmics--Phakic       recognition.
                                                             Intraocular Lenses.
10-60.......................  ............................  ISO 11981 Second edition      Extent of recognition.
                                                             2009-07-01 Ophthalmic
                                                             optics--Contact lenses and
                                                             contact lens care products--
                                                             Determination of physical
                                                             compatibility of contact
                                                             lens care products with
                                                             contact lenses.
10-62.......................  ............................  ANSI Z80.10-2009 Ophthalmic   Extent of recognition.
                                                             Instruments--Tonometers.
10-64.......................  10-89.......................  ANSI Z80.7-2013 Ophthalmics-- Withdrawn and replaced
                                                             Intraocular Lenses.           with newer version.
10-68.......................  ............................  ISO 13212 Second edition      Extent of recognition.
                                                             2011-05-15 Ophthalmic
                                                             optics--Contact lens care
                                                             products--Guidelines for
                                                             determination of shelf-life.
10-69.......................  ............................  ANSI Z80.18-2010 American     Extent of recognition.
                                                             National Standard for
                                                             Ophthalmics--Contact Lens
                                                             Care Products--Vocabulary,
                                                             Performance Specifications
                                                             and Test Methodology.
10-74.......................  ............................  ISO 10940 Second edition      Extent of recognition.
                                                             2009-08-01 Ophthalmic
                                                             instruments--Fundus Cameras.
----------------------------------------------------------------------------------------------------------------
                                                  M. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-190......................  11-256......................  ISO 14243-3 First edition     Withdrawn and replaced
                                                             2004-09-15 Implants for       with newer version
                                                             surgery--Wear of total knee-  including technical
                                                             joint prostheses--Part 3:     corrigendum.
                                                             Loading and displacement
                                                             parameters for wear-testing
                                                             machines with displacement
                                                             control and corresponding
                                                             environmental conditions
                                                             for test [Including:
                                                             TECHNICAL CORRIGENDUM
                                                             1(2006)].
11-218......................  ............................  ISO 14243-3:2004 TECHNICAL    Withdrawn. See 11-256.
                                                             CORRIGENDUM 1 Implants for
                                                             surgery--Wear of total knee-
                                                             joint prostheses--Part 3:
                                                             Loading and displacement
                                                             parameters for wear-testing
                                                             machines with displacement
                                                             control and corresponding
                                                             environmental conditions
                                                             for test.
11-210......................  11-257......................  ASTM F543-13 Standard         Withdrawn and replaced
                                                             Specification and Test        with a newer version.
                                                             Methods for Metallic
                                                             Medical Bone Screws.
11-212......................  ............................  ASTM F1440-92 (Reapproved     Withdrawn.
                                                             2008) Standard Practice for
                                                             Cyclic Fatigue Testing of
                                                             Metallic Stemmed Hip
                                                             Arthroplasty Femoral
                                                             Components Without Torsion.
11-241......................  ............................  ASTM F543-07 Standard         Withdrawn duplicate.
                                                             Specification and Test       See 11-257.
                                                             Methods for Metallic
                                                             Medical Bone Screws.
11-244......................  11-258......................  ASTM F2083-12 Standard        Withdrawn and replaced
                                                             Specification for Knee        with a newer version.
                                                             Replacement Prosthesis.
11-74.......................  ............................  ISO 5838-2 First edition      Extent of recognition.
                                                             1991-01-15 Implants for
                                                             surgery--Skeletal pins and
                                                             wires--Part 2: Steinmann
                                                             skeletal pins--Dimensions.
11-75.......................  ............................  ISO 5838-3 First edition      Extent of recognition.
                                                             1993-09-15 Implants for
                                                             surgery--Skeletal pins and
                                                             wires--Part 3: Kirschner
                                                             skeletal wires.
11-80.......................  ............................  ISO 8828 First edition 1988-  Extent of recognition.
                                                             10-15 Implants for surgery--
                                                             Guidance on care and
                                                             handling of orthopaedic
                                                             implants.
11-83.......................  ............................  ISO 13402 First edition 1995- Extent of recognition.
                                                             08-01 Surgical and dental
                                                             hand instruments--
                                                             Determination of resistance
                                                             against autoclaving,
                                                             corrosion and thermal
                                                             exposure.
11-168......................  ............................  ASTM F1781-03 (Reapproved     Extent of recognition.
                                                             2009) Standard
                                                             Specification for
                                                             Elastomeric Flexible Hinge
                                                             Finger Total Joint Implants.

11-171......................  ............................  ASTM F1814-97a (Reapproved    Extent of recognition.
                                                             2009) Standard Guide for
                                                             Evaluating Modular Hip and
                                                             Knee Joint Components.
11-183......................  ............................  ASTM F1875-98 (Reapproved     Extent of recognition.
                                                             2009) Standard Practice for
                                                             Fretting Corrosion Testing
                                                             of Modular Implant
                                                             Interfaces: Hip Femoral
                                                             Head-bore and Cone Taper
                                                             Interface.
11-184......................  ............................  ISO 8827 First edition 1988-  Extent of recognition.
                                                             10-15 Implants for surgery--
                                                             Staples with parallel legs
                                                             for orthopaedic use--
                                                             General requirements.
11-185......................  ............................  ASTM F2267-04 (Reapproved     Extent of recognition.
                                                             2011) Standard Test Method
                                                             for Measuring Load Induced
                                                             Subsidence of
                                                             Intervertebral Body Fusion
                                                             Device Under Static Axial
                                                             Compression.
11-191......................  ............................  ISO 14879-1 First edition     Extent of recognition.
                                                             2000-06-01 Implants for
                                                             surgery--Total knee-joint
                                                             prostheses--Part 1:
                                                             Determination of endurance
                                                             properties of knee tibial
                                                             trays.
11-196......................  ............................  ASTM F1672-95 (Reapproved     Extent of recognition.
                                                             2011) Standard
                                                             Specification for
                                                             Resurfacing Patellar
                                                             Prosthesis.
11-197......................  ............................  ASTM F983-86 (Reapproved      Reaffirmation and
                                                             2013) Standard Practice for   extent of
                                                             Permanent Marking of          recognition.
                                                             Orthopaedic Implant
                                                             Components.
11-199......................  ............................  ASTM F565-04 (Reapproved      Reaffirmation and
                                                             2013) Standard Practice for   extent of
                                                             Care and Handling of          recognition.
                                                             Orthopedic Implants and
                                                             Instruments.
11-203......................  ............................  ASTM F1541-02 (Reapproved     Extent of recognition.
                                                             2011) 1 Standard
                                                             Specification and Test
                                                             Methods for External
                                                             Skeletal Fixation Devices.
11-207......................  ............................  ASTM F2193-02 (Reapproved     Extent of recognition.
                                                             2007) Standard
                                                             Specifications and Test
                                                             Methods for Components Used
                                                             in the Surgical Fixation of
                                                             the Spinal Skeletal System.
11-211......................  ............................  ASTM F1798-97 (Reapproved     Extent of recognition.
                                                             2008) Standard Guide for
                                                             Evaluating the Static and
                                                             Fatigue Properties of
                                                             Interconnection Mechanisms
                                                             and Subassemblies Used in
                                                             Spinal Arthrodesis Implants.
11-214......................  ............................  ASTM F382-99 (Reapproved      Extent of recognition.
                                                             2008) \1\ Standard
                                                             Specification and Test
                                                             Method for Metallic Bone
                                                             Plates.
11-216......................  ............................  ASTM F1264-03 (Reapproved     Extent of recognition.
                                                             2012) Standard
                                                             Specification and Test
                                                             Methods for Intramedullary
                                                             Fixation Devices.
11-220......................  ............................  ASTM F2068-09 Standard        Extent of recognition.
                                                             Specification for Femoral
                                                             Prostheses--Metallic
                                                             Implants.
11-222......................  ............................  ISO 14243-1 Second edition    Extent of recognition.
                                                             2009-11-15 Implants for
                                                             surgery--Wear of total knee-
                                                             joint prostheses--Part 1:
                                                             Loading and displacement
                                                             parameters for wear-testing
                                                             machines with load control
                                                             and corresponding
                                                             environmental conditions
                                                             for test.
11-223......................  ............................  ISO 14243-2 Second edition    Extent of recognition.
                                                             2009-11-15 Implants for
                                                             surgery--Wear of total knee-
                                                             joint prostheses--Part 2:
                                                             Methods of measurement.
11-224......................  ............................  ASTM F2706-08 Standard Test   Extent of recognition.
                                                             Methods for Occipital-
                                                             Cervical and Occipital-
                                                             Cervical-Thoracic Spinal
                                                             Implant Constructs in a
                                                             Vertebrectomy Model.
11-225......................  ............................  ISO 7206-4 Third edition      Extent of recognition.
                                                             2010-06-15 Implants for
                                                             surgery--Partial and total
                                                             hip-joint prostheses--Part
                                                             4: Determination of
                                                             endurance properties and
                                                             performance of stemmed
                                                             femoral components.
11-226......................  ............................  ASTM F1089-10 Standard Test   Extent of recognition.
                                                             Method for Corrosion of
                                                             Surgical Instruments.
11-227......................  ............................  ASTM F366-10 Standard         Extent of recognition.
                                                             Specification for Fixation
                                                             Pins and Wires.
11-228......................  ............................  ASTM F564-10 Standard         Extent of recognition
                                                             Specification and Test
                                                             Methods for Metallic Bone
                                                             Staples.
11-231......................  ............................  ISO 7207-2 Second edition     Extent of recognition.
                                                             2011-07-01 Implants for
                                                             surgery--Components for
                                                             partial and total knee
                                                             joint prostheses--Part 2:
                                                             Articulating surfaces made
                                                             of metal, ceramic and
                                                             plastics materials.
11-232......................  ............................  ISO 7207-1 Third edition      Extent of recognition.
                                                             2007-02-01 Implants for
                                                             surgery--Components for
                                                             partial and total knee
                                                             joint prostheses--Part 1:
                                                             Classification, definitions
                                                             and designation of
                                                             dimensions.
11-234......................  ............................  ASTM F732-00 (Reapproved      Extent of recognition.
                                                             2011) Standard Test Method
                                                             for Wear Testing of
                                                             Polymeric Materials Used in
                                                             Total Joint Prostheses.
11-235......................  ............................  ASTM F2077-11 Test Methods    Extent of recognition.
                                                             for Intervertebral Body
                                                             Fusion Devices.
11-237......................  ............................  ISO 7206-6 First edition      Extent of recognition.
                                                             1992-03-15 Implants for
                                                             surgery--Partial and total
                                                             hip joint prostheses--Part
                                                             6: Determination of
                                                             endurance properties of
                                                             head and neck region of
                                                             stemmed femoral components.
11-238......................  ............................  ASTM F2033-12 Standard        Extent of recognition.
                                                             Specification for Total Hip
                                                             Joint Prosthesis and Hip
                                                             Endoprosthesis Bearing
                                                             Surfaces Made of Metallic,
                                                             Ceramic, and Polymeric
                                                             Materials.

11-239......................  ............................  ASTM F 2345-03 (Reapproved    Extent of recognition.
                                                             2013) Standard Test Methods   Reaffirmation.
                                                             for Determination of Static
                                                             and Cyclic Fatigue Strength
                                                             of Ceramic Modular Femoral
                                                             Heads.
11-240......................  ............................  ASTM F382-99 (Reapproved      Extent of recognition.
                                                             2008) \1\ Standard
                                                             Specification and Test
                                                             Method for Metallic Bone
                                                             Plates.
11-243......................  ............................  ASTM F2346-05 (Reapproved     Extent of recognition.
                                                             2011) Standard Test Methods
                                                             for Static and Dynamic
                                                             Characterization of Spinal
                                                             Artificial Discs.
11-245......................  ............................  ASTM F384-12 Standard         Extent of recognition.
                                                             Specifications and Test
                                                             Methods for Metallic Angled
                                                             Orthopedic Fracture
                                                             Fixation Devices.
11-247......................  ............................  ASTM F2789-10 Standard Guide  Extent of recognition.
                                                             for Mechanical and
                                                             Functional Characterization
                                                             of Nucleus Devices.
11-248......................  ............................  ISO 14242-1 Second edition    Extent of recognition.
                                                             2012-01-15 Implants for
                                                             surgery--Wear of total hip-
                                                             joint prostheses--Part 1:
                                                             Loading and displacement
                                                             parameters for wear-testing
                                                             machines and corresponding
                                                             environmental conditions
                                                             for test.
11-249......................  ............................  ISO 14242-2 First edition     Extent of recognition.
                                                             2000-09-15 Implants for
                                                             surgery--Wear of total hip-
                                                             joint prostheses--Part 2:
                                                             Methods of measurement.
11-250......................  ............................  ISO 14242-3 First edition     Extent of recognition.
                                                             2009-03-15 Implants for
                                                             surgery--Wear of total hip-
                                                             joint prostheses--Part 3:
                                                             Loading and displacement
                                                             parameters for orbital
                                                             bearing type wear testing
                                                             machines and corresponding
                                                             environmental conditions
                                                             for test.
----------------------------------------------------------------------------------------------------------------
                                              N. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-25.......................  ............................  ISO 7176-13 First edition     Extent of recognition.
                                                             1989-08-01 Wheelchairs--
                                                             Part 13: Determination of
                                                             coefficient of friction of
                                                             test surfaces.
16-27.......................  ............................  ISO 7176-15 First edition     Extent of recognition.
                                                             1996-11-15 Wheelchairs--
                                                             Part 15: Requirements for
                                                             information disclosure,
                                                             documentation and labeling.
16-29.......................  ............................  ISO 7176-6 Second edition     Extent of recognition.
                                                             2001-10-01 Wheelchairs--
                                                             Part 6: Determination of
                                                             maximum speed, acceleration
                                                             and deceleration of
                                                             electric wheelchairs.
16-158......................  ............................  ISO 7176-1 Second edition     Extent of recognition.
                                                             1999-10-01 Wheelchairs--
                                                             Part 1: Determination of
                                                             static stability.
16-159......................  ............................  ISO 7176-2 Second edition     Extent of recognition.
                                                             2001-06-15 Wheelchairs--
                                                             Part 2: Determination of
                                                             dynamic stability of
                                                             electric wheelchairs.
16-162......................  ............................  ISO 7176-4 Third edition      Extent of recognition.
                                                             2008-10-01 Wheelchairs--
                                                             Part 4: Energy consumption
                                                             of electric wheelchairs and
                                                             scooters for determination
                                                             of theoretical distance
                                                             range.
16-163......................  ............................  ISO 7176-5 Second edition     Extent of recognition.
                                                             2008-06-01 Wheelchairs--
                                                             Part 5: Determination of
                                                             overall dimensions, mass
                                                             and manoeuvring space.
16-164......................  ............................  ISO 7176-10 Second edition    Extent of recognition.
                                                             2008-11-01 Wheelchairs--
                                                             Part 10: Determination of
                                                             obstacle-climbing ability
                                                             of electrically powered
                                                             wheelchairs.
16-165......................  ............................  ISO 7176-14 Second edition    Extent of recognition.
                                                             2008-02-15 Wheelchairs--
                                                             Part 14: Power and control
                                                             systems for electrically
                                                             powered wheelchairs and
                                                             scooters--Requirements and
                                                             test methods.
16-166......................  ............................  ISO 7176-21 Second edition    Extent of recognition.
                                                             2009-04-01 Wheelchairs--
                                                             Part 21: Requirements and
                                                             test methods for
                                                             electromagnetic
                                                             compatibility of
                                                             electrically powered
                                                             wheelchairs and scooters,
                                                             and battery chargers.
16-167......................  ............................  ISO 7176-9: Third edition     Extent of recognition.
                                                             2009-11-15 Wheelchairs--
                                                             Part 9: Climatic tests for
                                                             electric wheelchairs.
16-168......................  ............................  ANSI/RESNA WC-1:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 1:
                                                             Requirements and Test
                                                             Methods for Wheelchairs
                                                             (including Scooters)
                                                             Section 1: Determination of
                                                             static stability.
16-169......................  ............................  ANSI/RESNA WC-2:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 2:
                                                             Additional Requirements for
                                                             Wheelchairs (including
                                                             Scooters) with Electrical
                                                             Systems Section 2:
                                                             Determination of dynamic
                                                             stability of electrically
                                                             powered wheelchairs.
16-170......................  ............................  ANSI/RESNA WC-2:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 2:
                                                             Additional Requirements for
                                                             Wheelchairs (including
                                                             Scooters) with Electrical
                                                             Systems Section 3:
                                                             Determination of
                                                             effectiveness of brakes.
16-171......................  ............................  ANSI/RESNA WC-2:2009 Section  Extent of recognition.
                                                             4: Energy consumption of
                                                             electrically powered
                                                             wheelchairs and scooters
                                                             for determination of
                                                             theoretical distance range.

16-172......................  ............................  ANSI/RESNA WC-1:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 1:
                                                             Requirements and Test
                                                             Methods for Wheelchairs
                                                             (including Scooters)
                                                             Section 5: Determination of
                                                             dimensions, mass and
                                                             maneuvering space.
16-173......................  ............................  ANSI/RESNA WC-2:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 2:
                                                             Additional Requirements for
                                                             Wheelchairs (including
                                                             Scooters) with Electrical
                                                             Systems Section 6:
                                                             Determination of maximum
                                                             speed, acceleration and
                                                             deceleration of
                                                             electrically powered
                                                             wheelchairs.
16-174......................  ............................  ANSI/RESNA WC-1:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs Volume 1:
                                                             Requirements and Test
                                                             Methods for Wheelchairs
                                                             (including Scooters)
                                                             Section 7: Method of
                                                             Measurement of Seating and
                                                             Wheel Dimensions.
16-175......................  ............................  ANSI/RESNA WC-1:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 1:
                                                             Requirements and Test
                                                             Methods for Wheelchairs
                                                             (including Scooters)
                                                             Section 8: Requirements and
                                                             test methods for static,
                                                             impact and fatigue
                                                             strengths.
16-176......................  ............................  ANSI/RESNA WC-2:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 2:
                                                             Additional Requirements for
                                                             Wheelchairs (including
                                                             Scooters) with Electrical
                                                             Systems Section 9: Climatic
                                                             tests for electrically
                                                             powered wheelchairs.
16-177......................  ............................  ANSI/RESNA WC-2:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 2:
                                                             Additional Requirements for
                                                             Wheelchairs (including
                                                             Scooters) with Electrical
                                                             Systems Section 10:
                                                             Determination of obstacle-
                                                             climbing ability of
                                                             electrically powered
                                                             wheelchairs.
16-178......................  ............................  ANSI/RESNA WC-1:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 1:
                                                             Requirements and Test
                                                             Methods for Wheelchairs
                                                             (including Scooters)
                                                             Section 11: Test dummies.
16-179......................  ............................  ANSI/RESNA WC-1:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 1:
                                                             Requirements and Test
                                                             Methods for Wheelchairs
                                                             (including Scooters)
                                                             Section 13: Determination
                                                             of coefficient of friction
                                                             of test surfaces.
16-180......................  ............................  ANSI/RESNA WC-2:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 2:
                                                             Additional Requirements for
                                                             Wheelchairs (including
                                                             Scooters) with Electrical
                                                             Systems Section 14: Power
                                                             and control systems for
                                                             electrically powered
                                                             wheelchairs--Requirements
                                                             and test methods.
16-181......................  ............................  ANSI/RESNA WC-1:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 1:
                                                             Requirements and Test
                                                             Methods for Wheelchairs
                                                             (including Scooters)
                                                             Section 15: Requirements
                                                             for information disclosure,
                                                             documentation and labeling.
16-182......................  ............................  ANSI/RESNA WC-1:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 1:
                                                             Requirements and Test
                                                             Methods for Wheelchairs
                                                             (including Scooters)
                                                             Section 16: Resistance to
                                                             ignition of upholstered
                                                             parts--Requirements and
                                                             test methods.
16-183......................  ............................  ANSI/RESNA WC-1:2009          Extent of recognition
                                                             American National Standard
                                                             for Wheelchairs--Volume 1:
                                                             Requirements and Test
                                                             Methods for Wheelchairs
                                                             (including Scooters)
                                                             Section 20: Determination
                                                             of the performance of stand-
                                                             up type wheelchairs.
16-184......................  ............................  ANSI/RESNA WC-1:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 1:
                                                             Requirements and Test
                                                             Methods for Wheelchairs
                                                             (including Scooters)
                                                             Section 22: Set-up
                                                             procedures.
16-185......................  ............................  ANSI/RESNA WC-                Extent of recognition.
                                                             2:2009,American National
                                                             Standard for Wheelchairs--
                                                             Volume 2, Additional
                                                             Requirements for
                                                             Wheelchairs (including
                                                             Scooters) with Electrical
                                                             Systems Section 21:
                                                             Requirements and test
                                                             methods for electromagnetic
                                                             compatibility of
                                                             electrically powered
                                                             wheelchairs and motorized
                                                             scooters.
16-187......................  ............................  ANSI/RESNA WC-1:2009          Extent of recognition.
                                                             American National Standard
                                                             for Wheelchairs--Volume 1:
                                                             Requirements and Test
                                                             Methods for Wheelchairs
                                                             (including Scooters)
                                                             Section 26: Vocabulary.
----------------------------------------------------------------------------------------------------------------
                                                  O. Radiology
----------------------------------------------------------------------------------------------------------------
12-53.......................  12-257......................  ISO 2919 Third edition 2012-  Withdrawn and replaced
                                                             02-15 Radiological            with newer version.
                                                             protection--Sealed
                                                             radioactive sources--
                                                             General requirements and
                                                             classification.
12-59.......................  ............................  IEC 61168 First edition 1993- Extent of recognition.
                                                             12 Radiotherapy simulators--
                                                             Functional performance
                                                             characteristics.
12-66.......................  ............................  AIUM MUS, Medical Ultrasound  Extent of recognition.
                                                             Safety.

12-139......................  ............................  AIUM AOMS-2004, Acoustic      Extent of recognition.
                                                             Output Measurement Standard
                                                             for Diagnostic Ultrasound
                                                             Equipment.
12-140......................  ............................  AIUM RTD2-2004 Standard for   Withdrawn. See 12-209
                                                             Real-Time Display of          and 12-258.
                                                             Thermal and Mechanical
                                                             Acoustic Output Indices on
                                                             Diagnostic Ultrasound
                                                             Equipment Revision 2.
12-145......................  12-259......................  IEC 61674 Edition 2.0 2012-   Withdrawn and replaced
                                                             11 Medical electrical         with newer version.
                                                             equipment--Dosimeters with
                                                             ionization chambers and/or
                                                             semiconductor detectors as
                                                             used in X-ray diagnostic
                                                             imaging.
12-149......................  12-260......................  IEC 60336 Fourth edition      Withdrawn and replaced
                                                             2005-04 Medical electrical    with newer version
                                                             equipment--X-ray tube         including technical
                                                             assemblies for medical        corrigendum.
                                                             diagnosis--Characteristics
                                                             of focal spots [Including:
                                                             Technical Corrigendum 1
                                                             (2006)].
12-150......................  ............................  ISO/IEC 10918-1:1994          Withdrawn. See 12-261.
                                                             TECHNICAL CORRIGENDUM
                                                             1:2005 Information
                                                             technology--Digital
                                                             compression and coding of
                                                             continuous-tone still
                                                             image--Part 1: Requirements
                                                             and guidelines.
12-156......................  ............................  ISO 11670:2003 TECHNICAL      Withdrawn. See 12-262.
                                                             CORRIGENDUM 1:2004 Lasers
                                                             and laser-related
                                                             equipment--Test methods for
                                                             laser beam parameters--Beam
                                                             positional stability.
12-157......................  ............................  ISO 13694:2000 TECHNICAL      Withdrawn. See 12-263.
                                                             CORRIGENDUM 1:2005 Optics
                                                             and optical instruments--
                                                             Lasers and laser-related
                                                             equipment--Test methods for
                                                             laser beam power (energy)
                                                             density distribution.
12-159......................  12-264......................  NEMA MS 11-2010               Withdrawn and replaced
                                                             Determination of Gradient-    with newer version.
                                                             Induced Electric Fields In
                                                             Diagnostic Magnetic
                                                             Resonance Imaging.
12-167......................  12-265......................  NEMA NU 2-2012 Performance    Withdrawn and replaced
                                                             Measurements of Positron      with newer version.
                                                             Emission Tomographs (PETs).
12-179......................  ............................  ANSI/IESNA RP-27.3-2007,      Extent of recognition.
                                                             Recommended Practice for
                                                             Photobiological Safety for
                                                             Lamps--Risk Group
                                                             Classification and Labeling.
12-180......................  12-266......................  IEC 61689 Edition 3.0 2013-   Withdrawn and replaced
                                                             02 Ultrasonic-Physiotherapy   with newer version.
                                                             systems--Field
                                                             specifications and methods
                                                             of measurement in the
                                                             frequency range 0. 5 MHz to
                                                             5 MHz.
12-190......................  12-267......................  IEC 61217 Edition 2.0 2011-   Withdrawn and replaced
                                                             12 Radiotherapy equipment--   with newer version.
                                                             Coordinates, movements and
                                                             scales.
12-194......................  ............................  ANSI/HPS N43.6-2007, Sealed   Extent of recognition.
                                                             Radioactive Sources--
                                                             Classification.
12-207......................  12-271......................  IEC 60601-2-33 Edition 3.1    Withdrawn and replaced
                                                             2013-04 Medical electrical    with newer version.
                                                             equipment--Part 2-33:
                                                             Particular requirements for
                                                             the basic safety and
                                                             essential performance of
                                                             magnetic resonance
                                                             equipment for medical
                                                             diagnosis.
12-208......................  12-268......................  IEC 60601-2-22 Edition 3.1    Withdrawn and replaced
                                                             2012-10 Medical electrical    with newer version.
                                                             equipment--Part 2-22:
                                                             Particular requirements for
                                                             basic safety and essential
                                                             performance of surgical,
                                                             cosmetic, therapeutic and
                                                             diagnostic laser equipment.
12-210......................  12-269......................  IEC 60601-1-3 Edition 2.1     Withdrawn and replaced
                                                             2013-04 Medical electrical    with newer version.
                                                             equipment--Part 1-3:
                                                             General requirements for
                                                             basic safety and essential
                                                             performance--Collateral
                                                             Standard: Radiation
                                                             protection in diagnostic X-
                                                             ray equipment.
12-219......................  ............................  IEC 60336 (2005) Medical      Withdrawn. See 12-260.
                                                             electrical equipment--X-ray
                                                             tube assemblies for medical
                                                             diagnosis--Characteristics
                                                             of focal spots.
12-222......................  12-270......................  IEC 61223-3-5 First edition   Withdrawn and replaced
                                                             2004-08 Evaluation and        with newer version
                                                             routine testing in medical    including technical
                                                             imaging departments--Part 3-  corrigendum.
                                                             5: Acceptance tests--
                                                             Imaging performance of
                                                             computed tomography X-ray
                                                             equipment [Including:
                                                             TECHNICAL CORRIGENDUM 1
                                                             (2006)].
12-223......................  ............................  IEC 61223-3-5 (First edition  Withdrawn. See 12-270.
                                                             2004) Evaluation and
                                                             routine testing in medical
                                                             imaging departments--Part 3-
                                                             5: Acceptance tests--
                                                             Imaging performance of
                                                             computed tomography X-ray
                                                             equipment CORRIGENDUM 1.
12-227......................  ............................  IEC 61391-1 First edition     Extent of recognition.
                                                             2006-07 Ultrasonics--Pulse-
                                                             echo scanners--Part 1:
                                                             Techniques for calibrating
                                                             spatial measurement systems
                                                             and measurement of system
                                                             point-spread function
                                                             response.
12-228......................  ............................  IEC 61391-2 Edition 1.0 2010- Extent of recognition.
                                                             01 Ultrasonics--Pulse-echo
                                                             scanners--Part 2:
                                                             Measurement of maximum
                                                             depth of penetration and
                                                             local dynamic range.
12-233......................  12-262......................  ISO 11670 Second edition      Withdrawn and replaced
                                                             2003-04-01 Lasers and laser-  with newer version
                                                             related equipment--Test       including technical
                                                             methods for laser beam        corrigendum.
                                                             parameters--Beam positional
                                                             stability [Including:
                                                             TECHNICAL CORRIGENDUM 1
                                                             (2004)].
12-237......................  12-258......................  IEC 62359 Edition 2.0 2010-   Withdrawn and replaced
                                                             10 Ultrasonics--Field         with newer version
                                                             characterization--Test        including technical
                                                             methods for the               corrigendum.
                                                             determination of thermal
                                                             and mechanical indices
                                                             related to medical
                                                             diagnostic ultrasonic
                                                             fields [Including TECHNICAL
                                                             CORRIGENDUM 1 (2011)].

12-243......................  12-263......................  ISO 13694 First edition 2000- Withdrawn and replaced
                                                             04-01 Optics and optical      with newer version
                                                             instruments--Lasers and       including technical
                                                             laser-related equipment--     corrigendum.
                                                             Test methods for laser beam
                                                             power [energy] density
                                                             distribution [Including:
                                                             TECHNICAL CORRIGENDUM 1
                                                             (2005)].
12-244......................  ............................  IEC 62359 (Second edition     Withdrawn. See 12-258.
                                                             2010) March 2011
                                                             Ultrasonics--Field
                                                             characterization--Test
                                                             methods for the
                                                             determination of thermal
                                                             and mechanical indices
                                                             related to medical
                                                             diagnostic ultrasonic
                                                             fields CORRIGENDUM 1.
12-247......................  ............................  ISO 11990-1 First edition     Extent of recognition.
                                                             2011-08-01, Lasers and
                                                             laser-related equipment--
                                                             Determination of laser
                                                             resistance of tracheal
                                                             tubes--Part 1: Tracheal
                                                             tube shaft.
----------------------------------------------------------------------------------------------------------------
                                             P. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-4........................  ............................  ANSI/UL 1998 Standards for    Extent of recognition.
                                                             Safety Software in
                                                             Programmable Components,
                                                             Second Edition. [This
                                                             Standard contains revisions
                                                             through and including
                                                             October 28, 2008.]
----------------------------------------------------------------------------------------------------------------
                                                  Q. Sterility
----------------------------------------------------------------------------------------------------------------
14-143......................  14-395......................  ISO 14698-2 First edition     Withdrawn and replaced
                                                             2003-09-15 Cleanrooms and     with newer version
                                                             associated controlled         including technical
                                                             environments--Biocontaminat   corrigendum.
                                                             ion control--Part 2:
                                                             Evaluation and
                                                             interpretation of
                                                             biocontamination data.
                                                             [Including: TECHNICAL
                                                             CORRIGENDUM 1 Published
                                                             2004-11-01].
14-193......................  ............................  ANSI/AAMI/ISO 11607-1:2006/   Extent of recognition
                                                             (R)2010 Packaging for         and relevant
                                                             terminally sterilized         guidance.
                                                             medical devices--Part 1:
                                                             Requirements for materials,
                                                             sterile barrier systems and
                                                             packaging systems.
14-194......................  ............................  ANSI/AAMI/ISO 11607-2:2006/   Extent of recognition
                                                             (R)2010 Packaging for         and relevant
                                                             terminally sterilized         guidance.
                                                             medical devices--Part 2:
                                                             Validation requirements for
                                                             forming, sealing and
                                                             assembly processes.
14-195......................  ............................  ANSI/AAMI/ISO 11140-          Extent of recognition.
                                                             1:2005(R)2010 Sterilization
                                                             of health care products--
                                                             Chemical indicators--Part
                                                             1: General requirements.
14-201......................  14-396......................  ANSI/AAMI ST77:2013           Withdrawn and replaced
                                                             Containment devices for       with newer version.
                                                             reusable medical device
                                                             sterilization.
14-214......................  14-397......................  AOAC 6.2.04:2013 Official     Withdrawn and replaced
                                                             Method 955.15 Testing         with newer version.
                                                             Disinfectants Against
                                                             Staphylococcus aureus, Use-
                                                             Dilution Method.
14-218......................  14-398......................  AOAC 6.3.05:2013 Official     Withdrawn and replaced
                                                             Method 966.04 Sporicidal      with newer version.
                                                             Activity of Disinfectants
                                                             Method I.
14-219......................  14-399......................  AOAC 6.3.06:2012 Official     Withdrawn and replaced
                                                             Method 965.12                 with newer version.
                                                             Tuberculocidal Activity of
                                                             Disinfectants.
14-230......................  14-400......................  ASTM F2203-13 Standard Test   Withdrawn and replaced
                                                             Method for Linear             with newer version.
                                                             Measurement Using Precision
                                                             Steel Rule.
14-231......................  14-401......................  ASTM F2217/F2217M-13          Withdrawn and replaced
                                                             Standard Practice for         with newer version.
                                                             Coating/Adhesive Weight
                                                             Determination.
14-235......................  14-402......................  ASTM F1140/F1140M-13          Withdrawn and replaced
                                                             Standard Test Methods for     with newer version.
                                                             Internal Pressurization
                                                             Failure Resistance of
                                                             Unrestrained Packages.
14-236......................  14-403......................  ASTM F2054/F2054M-13          Withdrawn and replaced
                                                             Standard Test Method for      with newer version.
                                                             Burst Testing of Flexible
                                                             Package Seals Using
                                                             Internal Air Pressurization
                                                             Within Restraining Plates.
14-241......................  14-424......................  ISO 13408-6 First edition     Withdrawn and replaced
                                                             2005-06-15 Aseptic            with newer version
                                                             processing of health care     including amendment.
                                                             products--Part 6: Isolator
                                                             systems [Including
                                                             AMENDMENT 1 (2013)].
14-258......................  14-404......................  ASTM F2250-13 Standard        Withdrawn and replaced
                                                             Practice for Evaluation of    with newer version.
                                                             Chemical Resistance of
                                                             Printed Inks and Coatings
                                                             on Flexible Packaging
                                                             Materials.
14-260......................  14-405......................  ASTM F2252/F2252M-13[egr]1    Withdrawn and replaced
                                                             Standard Practice for         with newer version.
                                                             Evaluating Ink or Coating
                                                             Adhesion to Flexible
                                                             Packaging Materials Using
                                                             Tape.
14-264......................  14-406......................  ANSI/AAMI ST8:2013 Hospital   Withdrawn and replaced
                                                             steam sterilizers.            with newer version.
14-274......................  ............................  ANSI/AAMI/ISO 15882:2008      Extent of recognition
                                                             Sterilization of health       and relevant
                                                             care products--Chemical       guidance.
                                                             indicators--Guidance for
                                                             selection, use, and
                                                             interpretation of results.
14-285......................  ............................  ANSI/AAMI/ISO 14161:2009      Extent of recognition.
                                                             Sterilization of health
                                                             care products--Biological
                                                             indicators--Guidance for
                                                             the selection, use and
                                                             interpretation of results.
14-289......................  ............................  ISO 14698-2:2003 TECHNICAL    Withdrawn. See 14-395.
                                                             CORRIGENDUM Cleanrooms and
                                                             associated controlled
                                                             environments--Biocontaminat
                                                             ion control--Part 2:
                                                             Evaluation and
                                                             interpretation of
                                                             biocontamination data.

14-296......................  ............................  ANSI/AAMI/ISO 11138-1:2006/   Relevant guidance.
                                                             (R)2010, Sterilization of
                                                             health care products--
                                                             Biological indicators--Part
                                                             1: General requirements.
14-300......................  ............................  ASTM D4169-09 Standard        Extent of recognition.
                                                             Practice for Performance
                                                             Testing of Shipping
                                                             Containers and Systems.
14-326......................  14-407......................  ISO 11737-1 Second edition    Withdrawn and replaced
                                                             2006-04-01, Sterilization     with newer version
                                                             of medical devices--          including technical
                                                             Microbiological methods--     corrigendum.
                                                             Part 1: Determination of a
                                                             population of
                                                             microorganisms on products
                                                             [Including: TECHNICAL
                                                             CORRIGENDUM 1 Published
                                                             2007-05-15].
14-328......................  14-428......................  ISO 11137-1 First edition     Withdrawn and replaced
                                                             2006-04-15 Sterilization of   with newer version
                                                             health care products--        including amendment.
                                                             Radiation--Part 1:
                                                             Requirements for
                                                             development, validation and
                                                             routine control of a
                                                             sterilization process for
                                                             medical devices [Including
                                                             AMENDMENT 1 (2013)].
14-334......................  ............................  ISO 15882 Second edition      Extent of recognition,
                                                             2008-09-01 Sterilization of   title.
                                                             health care products--
                                                             Chemical indicators--
                                                             Guidance for selection, use
                                                             and interpretation of
                                                             results.
14-335......................  14-408......................  ISO 10993-7 Second edition    Withdrawn and replaced
                                                             2008-10-15 Biological         with newer version
                                                             evaluation of medical         including technical
                                                             devices--Part 7: Ethylene     corrigendum.
                                                             oxide sterilization
                                                             residuals [Including:
                                                             TECHNICAL CORRIGENDUM 1
                                                             Published 2009-11-15].
14-336......................  ............................  ISO 14161 Second edition      Extent of recognition.
                                                             2009-09-15 Sterilization of
                                                             health care products--
                                                             Biological indicators--
                                                             Guidance for the selection,
                                                             use and interpretation of
                                                             results.
14-338......................  ............................  ISO 11138-1 Second edition    Relevant guidance.
                                                             2006-07-01, Sterilization
                                                             of health care products--
                                                             Biological indicators--Part
                                                             1: General requirements.
14-352......................  14-425......................  ANSI/AAMI/ISO 13408-6:2005    Withdrawn and replaced
                                                             Aseptic processing of         with newer version
                                                             health care products--Part    including amendment.
                                                             6: Isolator systems
                                                             [Including AMENDMENT 1
                                                             (2013)].
14-353......................  ............................  ISO 11140-1 Second edition    Extent of recognition.
                                                             2005-07-15 Sterilization of
                                                             health care products--
                                                             Chemical indicators--Part
                                                             1: General requirements.
14-355......................  ............................  ISO 11607-1 First edition     Extent of recognition