[Federal Register Volume 77, Number 52 (Friday, March 16, 2012)]
[Notices]
[Pages 15765-15779]
[FR Doc No: 2012-6389]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451]

Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 028

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing a
publication containing modifications the Agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
recognized consensus standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 028'' (Recognition List Number: 028), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.

DATES: Submit either electronic or written comments concerning this
document at any time. See section VII of this document for the
effective date of the recognition of standards announced in this
document.

ADDRESSES: Submit written requests for single copies of ``Modifications
to the List of Recognized Standards, Recognition List Number: 028'' to
the Division of Small Manufacturers, International and Consumer
Assistance, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD
20993. Send two self-addressed adhesive labels to assist that office in
processing your requests, or fax your request to<PHONE_NUMBER>. Submit
electronic comments concerning this document to<EMAIL_ADDRESS>
Submit written comments concerning this document, or recommendations
for additional standards for recognition, to the contact person (see
FOR FURTHER INFORMATION CONTACT). This document may also be accessed on
FDA's Internet site at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI of
this document for electronic access to the searchable database for the
current list of FDA recognized consensus standards, including
Recognition List Number: 028 modifications and other standards related
information.

FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire

Ave., Bldg. 66, Rm. 3628, Silver Spring, MD 20993,<PHONE_NUMBER>.

I. Background

    Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended
section 514 allows FDA to recognize consensus standards developed by
international and national organizations for use in satisfying portions
of device premarket review submissions or other requirements.
    In a notice published in the Federal Register of February 25, 1998
(63 FR 9561), FDA announced the availability of a guidance entitled
``Recognition and Use of Consensus Standards.'' The notice described
how FDA would implement its standard recognition program and provided
the initial list of recognized standards.
    Modifications to the initial list of recognized standards, as
published in the Federal Register, are identified in table 1 of this
document.

       Table 1--Previous Publication of Standard Recognition Lists
------------------------------------------------------------------------

-------------------------------------------------------------------------
February 25, 1998 (63 FR 9561)
October 16, 1998 (63 FR 55617)
July 12, 1999 (64 FR 37546)
November 15, 2000 (65 FR 69022)
May 7, 2001 (66 FR 23032)
January 14, 2002 (67 FR 1774)
October 2, 2002 (67 FR 61893)
April 28, 2003 (68 FR 22391)
March 8, 2004 (69 FR 10712)
June 18, 2004 (69 FR 34176)
October 4, 2004 (69 FR 59240)
May 27, 2005 (70 FR 30756)
November 8, 2005 (70 FR 67713)
March 31, 2006 (71 FR 16313)
June 23, 2006 (71 FR 36121)
November 3, 2006 (71 FR 64718)
May 21, 2007 (72 FR 28500)
September 12, 2007 (72 FR 52142)
December 19, 2007 (72 FR 71924)
September 9, 2008 (73 FR 52358)
March, 18, 2009 (74 FR 11586)
September 8, 2009 (74 FR 46203)
May 5, 2010 (75 FR 24711)
June 10, 2010 (75 FR 32943)
October 4, 2010 (75 FR 61148)
March 14, 2011 (76 FR 13631)
August 2, 2011 (76 FR 46300)
------------------------------------------------------------------------

    These notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The Agency maintains ``hypertext
markup language (HTML)'' and ``portable document format (PDF)''
versions of the list of ``FDA Recognized Consensus Standards.'' Both
versions are publicly accessible at the Agency's Internet site. See
section VI of this document for electronic access information.
Interested persons should review the supplementary information sheet
for the standard to understand fully the extent to which FDA recognizes
the standard.

II. Modifications to the List of Recognized Standards, Recognition List
Number: 028

    FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency will recognize for
use in satisfying premarket reviews and other requirements for devices.
FDA will incorporate these modifications in the list of FDA Recognized
Consensus Standards in the Agency's searchable database. FDA will use
the term ``Recognition List Number: 028'' to identify these current
modifications.
    In table 2 of this document, FDA describes the following
modifications: (1) The withdrawal of standards and their replacement by
others, (2) the correction of errors made by FDA in listing previously
recognized standards, and (3) the changes to the supplementary
information sheets of recognized standards that describe revisions to
the applicability of the standards.
    In section III of this document, FDA lists modifications the Agency
is making that involve the initial addition of standards not previously
recognized by FDA.

                           Table 2--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
                                          Replacement
          Old recognition No.             recognition        Title of standard \1\               Change
                                              No.
----------------------------------------------------------------------------------------------------------------
                                                  A. Anesthesia
----------------------------------------------------------------------------------------------------------------
1-15..................................  ..............  ISO 5361-4 Second edition 1987- Contact person.
                                                         12-15 Tracheal tubes--Part 4:
                                                         Cole type.
1-18..................................  ..............  ISO 8359 Second edition 1996-   Contact person.
                                                         12-15 Oxygen concentrators
                                                         for medical use--Safety
                                                         requirements.
1-35..................................  ..............  ISO 5361 First edition 1999-09- Contact person.
                                                         15 Corrected and reprinted
                                                         1999-12-15 Anaesthetic and
                                                         respiratory equipment--
                                                         Tracheal tubes and connectors.
1-36..................................  ..............  ISO 5366-3 Second edition 2001- Contact person.
                                                         08-15 Anaesthetic and
                                                         respiratory equipment--
                                                         Tracheostomy tubes--Part 3:
                                                         Pediatric tracheostomy tubes.
1-44..................................  ..............  ISO 5366-1 Fourth edition 2000- Contact person.
                                                         12-15 Anaesthetic and
                                                         respiratory equipment--
                                                         Tracheostomy tubes--Part 1:
                                                         Tubes and connectors for use
                                                         in adults.
1-46..................................  ..............  ISO 5367 Fourth edition 2000-   Contact person.
                                                         06-01 Breathing tubes
                                                         intended for use with
                                                         anaesthetic apparatus and
                                                         ventilators.
1-56..................................  ..............  CGA V-7.1:1997 (Reaffirmed      Contact person.
                                                         2008) Standard Method of
                                                         Determining Cylinder Valve
                                                         Outlet Connections for
                                                         Medical Gases.
1-57..................................  ..............  ASTM F1101-90 (Reapproved       Contact person.
                                                         2003) \1\ Standard
                                                         Specification for Ventilators
                                                         Intended for Use During
                                                         Anesthesia.
1-58..................................  ..............  ASTM G175-03 (Reapproved 2011)  Reaffirmation.
                                                         Standard Test Method for
                                                         Evaluating the Ignition
                                                         Sensitivity and Fault
                                                         Tolerance of Oxygen
                                                         Regulators Used for Medical
                                                         and Emergency Applications.
1-60..................................  ..............  IEC 60601-2-12 [ISO 10651-1]    Contact person.
                                                         Second edition 2001-10
                                                         Medical electrical equipment--
                                                         Part 2-12: Particular
                                                         requirements for the safety
                                                         of lung ventilators--Critical
                                                         care ventilators.
1-62..................................  ..............  ISO 5356-1 Third edition 2004-  Contact person.
                                                         05-15 Anaesthetic and
                                                         respiratory equipment--
                                                         Conical connectors: Part 1:
                                                         Cones and sockets.

1-69..................................  ..............  ASTM F 1464-93 (Reapproved      Contact person.
                                                         2005) Standard Specification
                                                         for Oxygen Concentrators for
                                                         Domiciliary Use.
1-70..................................  ..............  ASTM F 1246-91 (Reapproved      Contact person.
                                                         2005) Standard Specification
                                                         for Electrically Powered Home
                                                         Care Ventilators, Part 1--
                                                         Positive-Pressure Ventilators
                                                         and Ventilator Circuits.
1-72..................................  ..............  ISO 10651-5 First edition 2006- Contact person.
                                                         02-01 Lung ventilators for
                                                         medical use--Particular
                                                         requirements for basic safety
                                                         and essential performance--
                                                         Part 5: Gas-powered emergency
                                                         resuscitators.
1-73..................................  ..............  ISO 10651-4 First edition 2002- Contact person.
                                                         03-01 Lung ventilators--Part
                                                         4: Particular requirements
                                                         for operator-powered
                                                         resuscitators.
1-75..................................  ..............  ISO 5362 Fourth edition 2006-   Contact person.
                                                         06-01 Anaesthetic reservoir
                                                         bags.
1-79..................................  ..............  ISO 26825 First edition 2008-   Contact person.
                                                         08-15 Corrected version 2009-
                                                         09-15 Anaesthetic and
                                                         respiratory equipment--User-
                                                         applied labels for syringes
                                                         containing drugs used during
                                                         anaesthesia--Colours, design
                                                         and performance.
----------------------------------------------------------------------------------------------------------------
                                               B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-87..................................           2-174  ISO 10993-10 Third Edition      Withdrawn and replaced
                                                         2010-08-01 Biological           with newer version.
                                                         evaluation of medical
                                                         devices--Part 10: Tests for
                                                         irritation and skin
                                                         sensitization.
2-93..................................  ..............  ASTM F763-04 (Reapproved 2010)  Reaffirmation.
                                                         Standard Practice for Short-
                                                         Term Screening of Implant
                                                         Materials.
2-94..................................  ..............  ASTM F981-04 (Reapproved 2010)  Reaffirmation.
                                                         Standard Practice for
                                                         Assessment of Compatibility
                                                         of Biomaterials for Surgical
                                                         Implants with Respect to
                                                         Effect of Materials on Muscle
                                                         and Bone.
2-108.................................  ..............  ASTM F1905-98 Standard          Withdrawn.
                                                         Practice for Selecting Tests
                                                         for Determining the
                                                         Propensity of Materials to
                                                         Cause Immunotoxicity.
2-114.................................  ..............  ASTM F1877-05 (Reapproved       Reaffirmation.
                                                         2010) Standard Practice for
                                                         Characterization of Particles.
2-117.................................  ..............  ANSI/AAMI/ISO 10993-            Extent of recognition
                                                         3:2003(R)2009 Biological        and Contact person.
                                                         evaluation of medical
                                                         devices--Part 3: Tests for
                                                         genotoxicity,
                                                         carcinogenicity, and
                                                         reproductive toxicity.
2-118.................................  ..............  ANSI/AAMI/ISO 10993-11:2006/    Reaffirmation.
                                                         (R)2010 Biological evaluation
                                                         of medical devices--Part 11:
                                                         Tests for systemic toxicity.
2-120.................................  ..............  ANSI/AAMI/ISO 10993-6:2007/     Reaffirmation.
                                                         (R)2010 Biological evaluation
                                                         of medical devices--Part 6:
                                                         Tests for local effects after
                                                         implantation.
2-126.................................  ..............  ASTM F748-06 (Reapproved 2010)  Reaffirmation.
                                                         Standard Practice for
                                                         Selecting Generic Biological
                                                         Test Methods for Materials
                                                         and Devices.
2-134.................................  ..............  ASTM F2065-00 (Reapproved       Reaffirmation.
                                                         2010) Standard Practice for
                                                         Testing for Alternative
                                                         Pathway Complement Activation
                                                         in Serum by Solid Materials.
2-155.................................  ..............  ASTM F2147-01 (Reapproved       Reaffirmation.
                                                         2010) Standard Practice for
                                                         Guinea Pig: Split Adjuvant
                                                         and Closed Patch Testing for
                                                         Contact Allergens.
2-157.................................           2-184  USP34-NF29:2011<87> Biological  Withdrawn and replaced
                                                         Reactivity Tests, In Vitro--    with newer version.
                                                         Direct Contact Test.
2-158.................................           2-185  USP 34-NF29:2011 Biological     Withdrawn and replaced
                                                         Tests <87> Biological           with newer version.
                                                         Reactivity Test, In Vitro--
                                                         Elution Test.
2-159.................................           2-186  USP 34-NF29:2011 Biological     Withdrawn and replaced
                                                         Tests <88> Biological           with newer version.
                                                         Reactivity Tests, In Vivo,
                                                         Procedure Preparation of
                                                         Sample.
2-160.................................           2-187  USP 34-NF29:2011 Biological     Withdrawn and replaced
                                                         Tests <88> Biological           with newer version.
                                                         Reactivity Test, In Vitro,
                                                         Classification of Plastics--
                                                         Intracutaneous Test.
2-161.................................           2-188  USP 34-NF29:2011 Biological     Withdrawn and replaced
                                                         Tests <88> Biological           with newer version.
                                                         Reactivity Tests, In Vivo
                                                         Classification of Plastics--
                                                         Systemic Injection Test.
2-165.................................  ..............  ANSI/AAMI/ISO 10993-14:2001     Reaffirmation.
                                                         (Reapproved 2006) Biological
                                                         evaluation of medical
                                                         devices--Part 14:
                                                         Identification and
                                                         quantification of degradation
                                                         products from ceramics.
2-166.................................           2-180  ANSI/AAMI/ISO 10993-16:2010     Withdrawn and replaced
                                                         Biological evaluation of        with newer version.
                                                         medical devices--Part 16:
                                                         Toxicokinetic study design
                                                         for degradation products and
                                                         leachables.
----------------------------------------------------------------------------------------------------------------
                                                C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-52..................................  ..............  ANSI/AAMI EC12:2000/(R)2010     Reaffirmation.
                                                         Disposable ECG electrodes.
3-61..................................            3-95  IEC 60601-2-27 Edition 3.0      Newer version with
                                                         2011-03 Medical electrical      transition period.
                                                         equipment--Part 2-27:
                                                         Particular requirements for
                                                         the basic safety and
                                                         essential performance of
                                                         electrocardiographic
                                                         monitoring equipment.
----------------------------------------------------------------------------------------------------------------

                                                  D. Dental/ENT
----------------------------------------------------------------------------------------------------------------
4-76..................................  ..............  ISO 7785-2 Second edition 1995- Contact person.
                                                         08-01 Dental handpieces--Part
                                                         2: Straight and geared angle
                                                         handpieces.
4-83..................................  ..............  ISO 11498 First edition 1997-   Contact person.
                                                         02-15 Dental handpieces--
                                                         Dental low-voltage electrical
                                                         motors.
4-84..................................  ..............  ISO 13294 First edition 1997-   Contact person.
                                                         05-01 Dental handpieces--
                                                         Dental air-motors.
4-90..................................  ..............  ANSI S3.39 Reaffirmed by ANSI   Contact person.
                                                         May 18, 2007 Specifications
                                                         for Instruments to Measure
                                                         Aural Acoustic Impedance and
                                                         Admittance (Aural Acoustic
                                                         Immittance).
4-119.................................  ..............  ANSI/ADA Specification No. 82-  Reaffirmation.
                                                         1998 (R2009) Reversible/
                                                         Irreversible Hydrocolloid
                                                         Impression Material Systems.
4-121.................................  ..............  ISO 7494-2 First edition 2003-  Contact person.
                                                         03-01 Dentistry--Dental
                                                         units--Part 2: Water and air
                                                         supply.
4-123.................................  ..............  ANSI/ASA S3.6-2004              Contact person.
                                                         Specification for Audiometers.
4-126.................................  ..............  ISO 10477 Second edition 2004-  Contact person.
                                                         10-01 Dentistry--Polymer-
                                                         based crown and bridge
                                                         materials.
4-134.................................  ..............  ISO 7494-1 First edition 2004-  Contact person.
                                                         08-15 Dentistry--Dental
                                                         units--Part 1: General
                                                         requirements and test methods.
4-136.................................  ..............  ASTM Designation: F2504-05      Contact person.
                                                         Standard Practice for
                                                         Describing System Output of
                                                         Implantable Middle Ear
                                                         Hearing Devices.
4-150.................................  ..............  ANSI/ADA Specification No. 19-  Contact person.
                                                         2003 Dental Elastometric
                                                         Impression Material:2003.
4-154.................................  ..............  ISO 4823 Third edition 2000-12- Contact person.
                                                         15 Dentistry--Elastometric
                                                         impression materials.
4-155.................................  ..............  ISO 4823:2000 Technical         Contact person.
                                                         Corrigendum 1 Published 2004-
                                                         07-15 Dentistry--Elastomeric
                                                         impression materials.
4-156.................................  ..............  ISO 4823 Third edition 2000-12- Contact person.
                                                         15 Amendment 1 2007-07-01
                                                         Dentistry--Elastometric
                                                         impression materials.
4-160.................................  ..............  ANSI S3.1-1999 (Reaffirmed by   Contact person.
                                                         ANSI October 28, 2008)
                                                         American National Standard
                                                         Maximum Permissible Ambient
                                                         Noise Levels for Audiometric
                                                         Test Rooms.
4-162.................................  ..............  ANSI S3.4-2007 American         Contact person.
                                                         National Standard Procedure
                                                         for the Computation of
                                                         Loudness of Steady Sounds.
4-163.................................  ..............  ANSI S3.5-1997 (R1986)          Contact person.
                                                         Reaffirmed by ANSI May 18,
                                                         2007 American National
                                                         Standard Methods for
                                                         Calculation of the Speech
                                                         Intelligibility Index.
4-164.................................  ..............  ANSI S3.7-1995 (Reaffirmed by   Contact person.
                                                         ANSI October 28, 2008)
                                                         American National Standard
                                                         Method for Coupler
                                                         Calibration of Earphones.
4-165.................................  ..............  ANSI S3.13-1987 Reaffirmed by   Contact person.
                                                         ANSI June 1, 2007 American
                                                         National Standard Mechanical
                                                         Coupler for Measurement of
                                                         Bone Vibrators.
4-170.................................  ..............  ANSI S3.36-1985 Reaffirmed by   Contact person.
                                                         ANSI on 4/27/2006 American
                                                         National Standard
                                                         Specification for a Manikin
                                                         for Simulated in-situ
                                                         Airborne Acoustic
                                                         Measurements.
4-171.................................  ..............  ANSI S3.37-1987 (Reaffirmed by  Contact person.
                                                         ANSI May 18, 2007) American
                                                         National Standard Preferred
                                                         Earhook Nozzle Thread for
                                                         Postauricular Hearing Aids.
4-172.................................  ..............  ANSI S3.42-1992 Reaffirmed by   Contact person.
                                                         ANSI May 18, 2007 American
                                                         National Standard Testing
                                                         Hearing Aids with a Broad-
                                                         Band Noise Signal.
4-173.................................  ..............  ANSI S3.44-1996 Reaffirmed by   Contact person.
                                                         ANSI on 27 April 2006
                                                         American National Standard
                                                         Determination of Occupational
                                                         Noise Exposure and Estimation
                                                         of Noise-Induced Hearing
                                                         Impairment.
4-175.................................  ..............  ANSI S3.46-1997 American        Contact person.
                                                         National Standard Methods of
                                                         Measurement of Real-Ear
                                                         Performance Characteristics
                                                         of Hearing Aids.
4-177.................................  ..............  ANSI S12.65-2006 (Reaffirmed    Reaffirmation.
                                                         by ANSI March 30, 2011)
                                                         American National Standard
                                                         For Rating Noise with Respect
                                                         to Speech Interference.
4-179.................................  ..............  ISO 7405 Second edition 2008-   Contact person.
                                                         12-15 Dentistry--Evaluation
                                                         of biocompatibility of
                                                         medical devices used in
                                                         dentistry.
4-180.................................  ..............  ISO 9168 Third edition 2009-07- Contact person.
                                                         15 Dentistry--Hose connectors
                                                         for air driven dental
                                                         handpieces.
4-183.................................  ..............  ANSI S3.2-2009 American         Contact person.
                                                         National Standard Method for
                                                         Measuring the Intelligibility
                                                         of Speech over Communication
                                                         Systems.
4-184.................................  ..............  ANSI/ASA S3.25-2009 American    Contact person.
                                                         National Standard For an
                                                         Occluded Ear Simulator.
4-185.................................  ..............  ANSI/ASA S3.45-2009 American    Contact person.
                                                         National Standard Procedures
                                                         for Testing Basic Vestibular
                                                         Function.

4-186.................................  ..............  ANSI/ASA S12.2-2008 American    Contact person.
                                                         National Standard Criteria
                                                         for Evaluating Room Noise.
4-190.................................  ..............  ANSI/ASA S3.35-2010 American    Contact person.
                                                         National Standard Method of
                                                         Measurement of Performance
                                                         Characteristics of Hearing
                                                         Aids Under Simulated Real-Ear
                                                         Working Conditions.
4-192.................................  ..............  ANSI/ADA Specification No. 58-  Contact person.
                                                         2010 Root Canal Files Type H
                                                         (Hedstrom): 2007.
----------------------------------------------------------------------------------------------------------------
                                                   E. General
----------------------------------------------------------------------------------------------------------------
5-29..................................  ..............  AAMI/ANSI HE74-2001 (R 2009)    Withdrawn, see 5-67.
                                                         Human factors design process
                                                         for medical devices.
5-39..................................  ..............  IEC 60812 Second edition 2006-  Contact person.
                                                         01 Analysis techniques for
                                                         system reliability--Procedure
                                                         for failure mode and effects
                                                         analysis (FMEA).
5-40..................................  ..............  ISO 14971 Second edition 2007-  Contact person.
                                                         03-01 Medical devices--
                                                         Application of risk
                                                         management to medical devices.
5-42..................................  ..............  ASTM D903-98 (Reapproved 2010)  Reaffirmation.
                                                         Standard Test Methods for
                                                         Peel or Stripping Strength of
                                                         Adhesive Bonds.
5-58..................................  ..............  IEC 60601-1-11 Edition          Extent of recognition
                                                         1.0:2010 Medical electrical     and relevant guidance.
                                                         equipment--Part 1-11: General
                                                         requirements for basic safety
                                                         and essential performance--
                                                         Collateral Standard:
                                                         Requirements for medical
                                                         electrical equipment and
                                                         medical electrical systems
                                                         used in the home healthcare
                                                         environment.
----------------------------------------------------------------------------------------------------------------
                                   F. General Hospital/General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
6-117.................................  ..............  ASTM F2172-02(2011) Standard    Reaffirmation and
                                                         Specification for Blood/        Contact person.
                                                         Intravenous Fluid/Irrigation
                                                         Fluid Warmers.
6-161.................................  ..............  ISO 10555-1 First edition 1995- Title and Contact
                                                         06-15 Sterile, Single-use       person.
                                                         intravascular catheters--Part
                                                         1: General requirements.
6-164.................................  ..............  ISO 10555-5 First edition 1996- Title and Contact
                                                         06-15 Sterile, single-use       person.
                                                         intravascular catheters--Part
                                                         5: Over-needle peripheral
                                                         catheters.
6-164.................................           6-266  ISO 10555-5 First edition 1996- See 6-164.
                                                         06-15 AMENDMENT 1 1999-01-15
                                                         Corrected and reprinted 1999-
                                                         07-15 Sterile, single-use
                                                         intravascular catheters--Part
                                                         5: Over-needle peripheral
                                                         catheters.
6-164.................................           6-267  ISO 10555-5:1996 TECHNICAL      See 6-164.
                                                         CORRIGENDUM 1 Published 2002-
                                                         06-15 Sterile, single-use
                                                         intravascular catheters--Part
                                                         5: Over-needle peripheral
                                                         catheters TECHNICAL
                                                         CORRIGENDUM.
6-176.................................  ..............  ASTM D7103-06 \1\ Standard      Editorial change.
                                                         Guide for Assessment of
                                                         Medical Gloves.
6-177.................................  ..............  ASTM E1112-00 (Reapproved       Reaffirmation.
                                                         2011) Standard Specification
                                                         for Electronic Thermometer
                                                         for Intermittent
                                                         Determination of Patient
                                                         Temperature.
6-198.................................           6-254  ASTM F2100-11, Standard         Withdrawn and replaced
                                                         Specification for Performance   with newer version.
                                                         of Materials Used in Medical
                                                         Face Masks.
6-203.................................  ..............  ASTM D6499-07, Standard Test    Extent of recognition.
                                                         Method for The Immunological
                                                         Measurement of Antigenic
                                                         Protein in Natural Rubber and
                                                         its Products.
6-219.................................           6-255  USP 34-NF 29<11>:2011 Sodium    Withdrawn and replaced
                                                         Chloride Irrigation.            with newer version.
6-226.................................           6-256  USP 34-NF 29<11>:2011 Sodium    Withdrawn and replaced
                                                         Chloride Injection.             with newer version.
6-246.................................           6-257  USP 34-NF 29 2011               Withdrawn and replaced
                                                         Nonabsorbable Surgical Suture.  with newer version.
6-248.................................           6-258  USP 34-NF 29 2011 <881>         Withdrawn and replaced
                                                         Tensile Strength.               with newer version.
6-249.................................           6-259  USP 34-NF 29 2011 <861>         Withdrawn and replaced
                                                         Sutures Diameter.               with newer version.
6-250.................................           6-260  USP 34-NF 29 2011 <871>         Withdrawn and replaced
                                                         Sutures--Needle.                with newer version.
6-251.................................           6-261  USP 34-NF 29 <11>:2011 Sterile  Withdrawn and replaced
                                                         Water for Irrigation.           with newer version.
6-252.................................           6-262  USP 34-NF 29 <11>:2011 Heparin  Withdrawn and replaced
                                                         Lock Flush Solution.            with newer version.
----------------------------------------------------------------------------------------------------------------
                                             G. In Vitro Diagnostics
----------------------------------------------------------------------------------------------------------------
7-102.................................           7-221  CLSI H01-A6 Tubes and           Withdrawn and replaced
                                                         Additives for Venous and        with newer version.
                                                         Capillary Blood Specimen
                                                         Collection; Approved
                                                         Standard--Sixth Edition.
7-112.................................  ..............  CLSI H49-A Point-of-Care        Withdrawn duplicate, see
                                                         Monitoring of Anticoagulation   7-162.
                                                         Therapy; Approved Guideline.

7-126.................................           7-222  CLSI M24-A2 Susceptibility      Withdrawn and replaced
                                                         Testing of Mycobacteria,        with newer version
                                                         Nocardiae, and Other Aerobic    Contact person.
                                                         Actinomycetes; Approved
                                                         Standards--Second Edition.
7-128.................................  ..............  CLSI EP14-A2 Evaluation of      Withdrawn duplicate, see
                                                         Matrix Effects; Approved        7-143.
                                                         Guideline--Second Edition.
7-130.................................  ..............  CLSI H20-A2 Reference           Withdrawn duplicate, see
                                                         Leukocyte (WBC) Differential    7-165.
                                                         Count (Proportional) and
                                                         Evaluation of Instrumental
                                                         Methods; Approved Standard--
                                                         Second Edition.
7-134.................................  ..............  CLSI GP20-A2 Fine Needle        Withdrawn duplicate, see
                                                         Aspiration Biopsy (FNAB)        7-166.
                                                         Techniques; Approved
                                                         Guideline--Second Edition.
7-140.................................           7-223  GP22-A3--Quality Management     Withdrawn and replaced
                                                         System: Continual               with newer version.
                                                         Improvement; Approved
                                                         Guideline--Third Edition.
7-143.................................  ..............  CLSI EP14-A2 Evaluation of      Contact person, Type of
                                                         Matrix Effects; Approved        standard, Processes
                                                         Guideline--Second Edition.      impacted.
7-147.................................  ..............  CLSI M22-A3 Quality Control     Withdrawn duplicate, see
                                                         for Commercially Prepared       7-178.
                                                         Microbiological Culture
                                                         Media; Approved Standard--
                                                         Third Edition.
7-150.................................  ..............  CLSI H43-A2 Clinical Flow       Title, Contact person.
                                                         Cytometric Analysis of
                                                         Neoplastic Hematolymphoid
                                                         Cells; Approved Guideline--
                                                         Second Edition.
7-162.................................  ..............  CLSI H49-A Point-of-Care        Contact person, Devices
                                                         Monitoring of Anticoagulation   affected, Processes
                                                         Therapy; Approved Guideline.    affected, Type of
                                                                                standard, CFR citation
                                                                                and product codes.
7-165.................................  ..............  CLSI H20-A2 Reference           Contact person, Devices
                                                         Leukocyte (WBC) Differential    affected, Processes
                                                         Count (Proportional) and        affected, Type of
                                                         Evaluation of Instrumental      standard, CFR citation
                                                         Methods; Approved Standard--    and product codes.
                                                         Second Edition.
7-166.................................  ..............  CLSI GP20-A2 Fine Needle        Devices affected,
                                                         Aspiration Biopsy (FNAB)        Process affected, CFR
                                                         Techniques; Approved            citation and product
                                                         Guideline--Second Edition.      codes.
7-169.................................  ..............  CLSI M27-A3 Reference Method    Withdrawn duplicate, see
                                                         for Broth Dilution Antifungal   7-204.
                                                         Susceptibility Testing of
                                                         Yeasts; Approved Standard--
                                                         Third Edition.
7-172.................................  ..............  CLSI C28-A3 Defining,           Withdrawn duplicate, see
                                                         Establishing, and Verifying     7-224.
                                                         Reference Intervals in the
                                                         Clinical Laboratory; Approved
                                                         Guideline--Third Edition.
7-202.................................           7-224  CLSI C28-A3c Defining,          Withdrawn and replaced
                                                         Establishing, and Verifying     with newer version.
                                                         Reference Intervals in the
                                                         Clinical Laboratory; Approved
                                                         Guideline--Third Edition.
7-178.................................  ..............  CLSI M22-A3 Quality Control     Extent of recognition,
                                                         for Commercially Prepared       CFR citation and
                                                         Microbiological Culture         product codes.
                                                         Media; Approved Standard--
                                                         Third Edition.
7-204.................................  ..............  CLSI M27-A3 Reference Method    Contact person.
                                                         for Broth Dilution Antifungal
                                                         Susceptibility Testing of
                                                         Yeasts; Approved Standard--
                                                         Third Edition.
7-206.................................  ..............  CLSI I/LA 20-A2 Analytical      Title, Contact person.
                                                         Performance Characteristics
                                                         and Clinical Utility of
                                                         Immunological Assays for
                                                         Human Immunoglobulin E (IgE)
                                                         Antibodies and Defined
                                                         Allergen Specificities;
                                                         Approved Guideline--Second
                                                         Edition.
----------------------------------------------------------------------------------------------------------------
                                                  H. Materials
----------------------------------------------------------------------------------------------------------------
11-219................................           8-203  ASTM F2026-08 Standard          Transferred.
                                                         Specification for
                                                         Polyetheretherketone (PEEK)
                                                         Polymers for Surgical Implant
                                                         Applications.
8-101.................................           8-204  ASTM F2118-10 Standard Test     Withdrawn and replaced
                                                         Method for Constant Amplitude   with newer version.
                                                         of Force Controlled Fatigue
                                                         Testing of Acrylic Bone
                                                         Cement Materials.
8-105.................................           8-205  ASTM F1635-11 Standard Test     Withdrawn and replaced
                                                         Method for in vitro             with newer version.
                                                         Degradation Testing of
                                                         Hydrolytically Degradable
                                                         Polymer Resins and Fabricated
                                                         Forms for Surgical Implants.
8-114.................................  ..............  ASTM F2255-05 (Reapproved       Reaffirmation.
                                                         2010) Standard Test Method
                                                         for Strength Properties of
                                                         Tissue Adhesives in Lap-Shear
                                                         by Tension Loading.
8-115.................................  ..............  ASTM F2256-05 (Reapproved       Reaffirmation.
                                                         2010) Standard Test Method
                                                         for Strength Properties of
                                                         Tissue Adhesives in T-Peel by
                                                         Tension Loading.
8-116.................................  ..............  ASTM F2258-05 (Reapproved       Reaffirmation.
                                                         2010) Standard Test Method
                                                         for Strength Properties of
                                                         Tissue Adhesives in Tension.
8-119.................................           8-206  ASTM F688-10 Standard           Withdrawn and replaced
                                                         Specification for Wrought       with newer version.
                                                         Cobalt-35 Nickel-20 Chromium-
                                                         10 Molybdenum Alloy Plate,
                                                         Sheet, and Foil for Surgical
                                                         Implants (UNS R30035).
8-121.................................  ..............  ASTM F2005-05 (Reapproved       Reaffirmation.
                                                         2010) Standard Terminology
                                                         for Nickel-Titanium Shape
                                                         Memory Alloys.
8-125.................................  ..............  ASTM F2004-05 (Reapproved       Reaffirmation.
                                                         2010) Standard Test Method
                                                         for Transformation
                                                         Temperature of Nickel-
                                                         Titanium Alloys by Thermal
                                                         Analysis.

8-126.................................  ..............  ASTM F561-05a (Reapproved       Reaffirmation.
                                                         2010) Standard Practice for
                                                         Retrieval and Analysis of
                                                         Medical Devices, and
                                                         Associated Tissues and Fluids.
8-132.................................  ..............  ASTM F1088-04a (Reapproved      Reaffirmation and
                                                         2010) Standard Specification    contact person.
                                                         for Beta-Tricalcium Phosphate
                                                         for Surgical Implantation.
8-135.................................  ..............  ASTM F2392-04 (Reapproved       Reaffirmation.
                                                         2010) Standard Test Method
                                                         for Burst Strength of
                                                         Surgical Sealants.
8-136.................................  ..............  ASTM F2458-05 (Reapproved       Reaffirmation.
                                                         2010) Standard Test Method
                                                         for Wound Closure Strength of
                                                         Tissue Adhesives and Sealants.
8-172.................................           8-207  ASTM F1926/F1926M-10 Standard   Withdrawn and replaced
                                                         Test Method for Evaluation of   with newer version.
                                                         the Environmental Stability
                                                         of Calcium Phosphate
                                                         Granules, Fabricated Forms,
                                                         and Coatings.
8-178.................................           8-208  ASTM F648-10a Standard          Withdrawn and replaced
                                                         Specification for Ultra-High-   with newer version.
                                                         Molecular-Weight Polyethylene
                                                         Powder and Fabricated Form
                                                         for Surgical Implants.
8-181.................................           8-209  ASTM F899-11 Standard           Withdrawn and replaced
                                                         Specification for Wrought       with newer version.
                                                         Stainless Steels for Surgical
                                                         Instruments.
8-191.................................           8-210  ASTM F2182-11 Standard Test     Withdrawn and replaced
                                                         Method for Measurement of       with newer version.
                                                         Radio Frequency Induced
                                                         Heating On or Near Passive
                                                         Implants During Magnetic
                                                         Resonance Imaging.
8-195.................................  ..............  ASTM F2024-10, Standard         Extent of Recognition,
                                                         Practice for X-Ray              devices affected, CFR
                                                         Diffraction Determination of    citations and
                                                         Phase Content of Plasma-        associated procodes and
                                                         Sprayed Hydroxyapatite          contact person.
                                                         Coatings.
----------------------------------------------------------------------------------------------------------------
                                                  I. Neurology
----------------------------------------------------------------------------------------------------------------
17-1..................................  ..............  ANSI/AAMI NS28:1988/(R) 2010    Reaffirmation.
                                                         Intracranial pressure
                                                         monitoring devices.
17-3..................................  ..............  ISO 7197:2006 Third edition     Contact person.
                                                         2006-06-01 Neurosurgical
                                                         implants--Sterile, single-use
                                                         hydrocephalus shunts and
                                                         components.
17-4..................................  ..............  ASTM F 647-94 (Reapproved       Contact person.
                                                         2006) Standard Practice for
                                                         Evaluating and Specifying
                                                         Implantable Shunt Assemblies
                                                         for Neurosurgical Application.
17-7..................................  ..............  ISO 7197:2006 Technical         Contact person.
                                                         Corrigendum 1 Published:2007-
                                                         07-01 Neurological implants--
                                                         Sterile, single-use
                                                         hydrocephalus shunts and
                                                         components.
----------------------------------------------------------------------------------------------------------------
                                           J. OB-GYN/Gastroenterology
----------------------------------------------------------------------------------------------------------------
9-21..................................  ..............  ISO 8600-4 First edition 1997-  Contact person.
                                                         07-01 Optics and optical
                                                         instruments--Medical
                                                         endoscopes and certain
                                                         accessories--Part 4:
                                                         Determination of maximum
                                                         width of insertion portion.
9-37..................................  ..............  ISO 8600-1 Second edition 2005- Contact person.
                                                         05-01 Optics and photonics--
                                                         Medical endoscopes and
                                                         endotherapy devices--Part 1:
                                                         General requirements.
9-38..................................  ..............  ISO 8600-3 First edition 1997-  Contact person.
                                                         07-01 AMENDMENT 1 2003-12-01
                                                         Optics and optical
                                                         instruments--Medical
                                                         endoscopes and endoscopic
                                                         accessories Part 3:
                                                         Determination of field of
                                                         view and direction of view of
                                                         endoscopes with optics.
9-39..................................  ..............  ISO 8600-5 First edition 2005-  Contact person.
                                                         03-15 Optics and photonics--
                                                         Medical endoscopes and
                                                         endotherapy devices--Part 5:
                                                         Determination of optical
                                                         resolution of rigid
                                                         endoscopes with optics.
9-40..................................  ..............  ISO 8600-6 First edition 2005-  Contact person.
                                                         03-15 Optics and photonics--
                                                         Medical endoscopes and
                                                         endotherapy devices--Part 6:
                                                         Vocabulary.
9-44..................................  ..............  ASTM Designation: F 623-99      Contact person.
                                                         (Reapproved 2006) Standard
                                                         Performance Specification for
                                                         Foley Catheter.
9-49..................................  ..............  AAMI/ANSI RD61:2006,            Withdrawn, see 9-73.
                                                         Concentrates for hemodialysis.
9-50..................................  ..............  ANSI/AAMI RD52:2004/(R)2010     Withdrawn, see 9-70 and
                                                         Dialysate for Hemodialysis.     9-71.
9-53..................................  ..............  ASTM F 1992-99 (Reapproved      Contact person.
                                                         2007) Standard Practice for
                                                         Reprocessing of Reusable,
                                                         Heat-Stable Endoscopic
                                                         Accessory Instruments (EAI)
                                                         Used with Flexible Endoscopes.
9-55..................................  ..............  AAMI/ANSI RD62:2006 and ANSI/   Withdrawn, see 9-69.
                                                         AAMI RD62:2006/A1:2009, Water
                                                         treatment equipment for
                                                         hemodialysis applications.
9-61..................................  ..............  IEC 60601-2-18 Edition 3.0      Contact person.
                                                         2009-08 Medical electrical
                                                         equipment--Part 2-18:
                                                         Particular requirements for
                                                         the basic safety and
                                                         essential performance of
                                                         endoscopic equipment.
9-59..................................  ..............  AAMI/ANSI RD5:2003/(R)2008,     Withdrawn, see 9-72.
                                                         Hemodialysis.
----------------------------------------------------------------------------------------------------------------

                                                  K. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-15.................................  ..............  ISO 9394 Second edition 1998-   Contact person.
                                                         08-15 Ophthalmic optics--
                                                         Contact lenses and contact
                                                         lens care products--
                                                         Determination of
                                                         biocompatibility by ocular
                                                         study using rabbit eyes.
10-24.................................           10-67  ISO 11986 Second edition 2010-  Withdrawn and replaced
                                                         11-01 Ophthalmic optics--       with newer version.
                                                         Contact lenses and contact
                                                         lens care products--
                                                         Determination of preservative
                                                         uptake and release.
10-26.................................           10-68  ISO 13212 Second edition 2011-  Withdrawn and replaced
                                                         05-15 Ophthalmic optics--       with newer version.
                                                         Contact lens care products--
                                                         Guidelines for determination
                                                         of shelf-life.
10-28.................................  ..............  ISO 14729 First edition 2001-   Contact person.
                                                         04-15 Ophthalmic optics--
                                                         Contact lens care products--
                                                         Microbiological requirements
                                                         and test methods for products
                                                         and regimens for hygienic
                                                         management of contact lenses.
10-29.................................  ..............  ISO 14730 First edition 2000-   Contact person.
                                                         09-15 Ophthalmic optics--
                                                         Contact lens care products--
                                                         Antimicrobial preservative
                                                         efficacy testing and guidance
                                                         on determining discard date.
10-33.................................           10-69  ANSI Z80.18-2010 for            Withdrawn and replaced
                                                         Ophthalmics--Contact Lens       with newer version.
                                                         Care Products--Vocabulary,
                                                         Performance Specifications,
                                                         and Test Methodology.
10-38.................................           10-70  ISO 10943 Third edition 2011-   Withdrawn and replaced
                                                         08-15 Ophthalmic instruments--  with newer version.
                                                         Indirect ophthalmoscopes.
10-59.................................  ..............  ISO 11980 Second edition 2009-  Contact person.
                                                         10-15 Ophthalmic optics--
                                                         Contact lenses and contact
                                                         lens care products--Guidance
                                                         for clinical investigations.
----------------------------------------------------------------------------------------------------------------
                                                  L. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-167................................          11-226  ASTM F1089-10 Standard Test     Withdrawn and replaced
                                                         Method for Corrosion of         with newer version.
                                                         Surgical Instruments.
11-180................................          11-227  ASTM F366-10 Standard           Withdrawn and replaced
                                                         Specification for Fixation      with newer version;
                                                         Pins and Wires.                 change contact.
11-196................................  ..............  ASTM F1672-95 (Reapproved       Reaffirmation.
                                                         2011) Standard Specification
                                                         for Resurfacing Patellar
                                                         Prosthesis.
11-201................................          11-228  ASTM F564-10 Standard           Withdrawn and replaced
                                                         Specification and Test          with newer version.
                                                         Methods for Metallic Bone
                                                         Staples.
11-217................................          11-229  ASTM F2083-10 Standard          Withdrawn and replaced
                                                         Specification for Total Knee    with newer version.
                                                         Prosthesis.
11-221................................          11-230  ASTM F1717-10 Standard Test     Withdrawn and replaced
                                                         Methods for Spinal Implant      with newer version.
                                                         Constructs in a Vertebrectomy
                                                         Model.
11-155................................          11-231  ISO 7207-2 Second edition 2011- Withdrawn and replaced
                                                         07-01 Implants for surgery--    with newer version.
                                                         Components for partial and
                                                         total knee joint prostheses--
                                                         Part 2: Articulating surfaces
                                                         made of metal, ceramic and
                                                         plastics materials.
11-219................................           8-203  ASTM F2026-10 Standard          Transferred and replaced
                                                         Specification for               with a newer version.
                                                         Polyetheretherketone (PEEK)
                                                         Polymers for Surgical Implant
                                                         Applications.
----------------------------------------------------------------------------------------------------------------
                                                  M. Radiology
----------------------------------------------------------------------------------------------------------------
12-52.................................  ..............  UL 544 (1998), Standard for     Withdrawn, see 5-4 and 5-
                                                         Medical and Dental Equipment--  52.
                                                         Ed. 4.0.
12-62.................................  ..............  UL 187 (1998), Standard for X-  Withdrawn, see 5-4 and 5-
                                                         ray Equipment--Ed. 7.0.         52.
12-100................................  ..............  NEMA UD 3-2004 (R2009),         Reaffirmation.
                                                         Standard for Real Time
                                                         Display of Thermal and
                                                         Mechanical Acoustic Output
                                                         Indices on Diagnostic
                                                         Ultrasound Equipment,
                                                         Revision 2.
12-105................................  ..............  NEMA UD 2-2004 (R2009),         Reaffirmation.
                                                         Acoustic Output Measurement
                                                         Standard for Diagnostic
                                                         Ultrasound Equipment,
                                                         Revision 3.
12-106................................  ..............  ISO 17526 First edition 2003-   Contact person.
                                                         06-15, Optics and optical
                                                         instruments--Lasers and laser-
                                                         related equipment--Lifetime
                                                         of lasers.
12-108................................          12-246  ISO 21254-2 First edition 2011- Withdrawn and replaced
                                                         07-15 Lasers and laser-         with newer version.
                                                         related equipment--Test
                                                         methods for laser-induced
                                                         damage threshold--Part 2:
                                                         Threshold determination.
12-109................................          12-245  ISO 21254-1 First edition 2011- Withdrawn and replaced
                                                         07-15 Lasers and laser-         with newer version.
                                                         related equipment--Test
                                                         methods for laser-induced
                                                         damage threshold--Part 1:
                                                         Definitions and general
                                                         principles.
12-110................................  ..............  ISO 11551 Second edition 2003-  Contact person.
                                                         12-01, Optics and optical
                                                         instruments--Lasers and laser-
                                                         related equipment--Test
                                                         method for absorptance of
                                                         optical laser components.
12-113................................  ..............  ISO 12005 Second edition 2003-  Contact person.
                                                         04-01, Lasers and laser-
                                                         related equipment--Test
                                                         methods for laser beam
                                                         parameters--Polarization.
12-115................................  ..............  ISO 13695 First edition 2004-   Contact person.
                                                         06-01, Optics and photonics--
                                                         Lasers and laser-related
                                                         equipment--Test methods for
                                                         the spectral characteristics
                                                         of lasers.

12-117................................  ..............  ISO 15367-1 First edition 2003- Contact person.
                                                         09-15, Lasers and laser-
                                                         related equipment--Test
                                                         methods for determination of
                                                         the shape of a laser beam
                                                         wavefront--Part 1:
                                                         Terminology and fundamental
                                                         aspects.
12-134................................  ..............  ISO 11146-1 First edition 2005- Contact person.
                                                         01-15, Lasers and laser-
                                                         related equipment--Test
                                                         methods for laser beam
                                                         widths, divergence angles and
                                                         beam propagation ratios--Part
                                                         1: Stigmatic and simple
                                                         astigmatic beams.
12-140................................  ..............  AIUM RTD2-2004, Standard for    Title.
                                                         Real-Time Display of Thermal
                                                         and Mechanical Acoustic
                                                         Output Indices on Diagnostic
                                                         Ultrasound Equipment Revision
                                                         2.
12-142................................  ..............  ISO 11146-2 First edition 2005- Contact person.
                                                         02-15, Lasers and laser-
                                                         related equipment--Test
                                                         methods for laser beam
                                                         widths, divergence angles and
                                                         beam propagation ratios--Part
                                                         2: General astigmatic beams.
12-143................................  ..............  ISO 15367-2 First edition 2005- Contact person.
                                                         03-15, Lasers and laser-
                                                         related equipment--Test
                                                         methods for determination of
                                                         the shape of a laser beam
                                                         wavefront--Part 2: Shack-
                                                         Hartman sensors.
12-144................................          12-247  ISO 11990-1 First edition 2011- Withdrawn and replaced
                                                         08-01 Lasers and laser-         with newer version.
                                                         related equipment--
                                                         Determination of laser
                                                         resistance of tracheal tubes--
                                                         Part 1: Tracheal tube shaft.
12-154................................          12-248  ISO 21254-3 First edition 2011- Withdrawn and replaced
                                                         07-15 Lasers and laser-         with newer version.
                                                         related equipment--Test
                                                         methods for laser-induced
                                                         damage threshold--Part 3:
                                                         Assurance of laser power
                                                         (energy) handling
                                                         capabilities.
12-155................................  ..............  ISO 11554 Third edition 2006-   Contact person.
                                                         05-01, Optics and photonics--
                                                         Lasers and laser-related
                                                         equipment--Test methods for
                                                         laser beam power, energy and
                                                         temporal characteristics.
12-156................................  ..............  ISO 11670:2003 Technical        Contact person.
                                                         Corrigendum 1 Published 2004-
                                                         05-15, Lasers and laser-
                                                         related equipment--Test
                                                         methods for laser beam
                                                         parameters--Beam positional
                                                         stability.
12-157................................  ..............  ISO 13694:2000 Technical        Contact person.
                                                         Corrigendum 1 Published 2005-
                                                         11-01, Optics and optical
                                                         instruments--Lasers and laser-
                                                         related equipment--Test
                                                         methods for laser beam power
                                                         (energy) density distribution.
12-174................................  ..............  ISO 13697 First edition 2006-   Contact person.
                                                         05-15, Optics and photonics--
                                                         Lasers and laser-related
                                                         equipment--Test methods for
                                                         specular reflectance and
                                                         regular transmittance of
                                                         optical laser components.
12-175................................  ..............  ISO 24013 First edition 2006-   Contact person.
                                                         11-15, Optics and photonics--
                                                         Lasers and laser-related
                                                         equipment--Measurement of
                                                         phase retardation of optical
                                                         components for polarized
                                                         laser radiation.
12-177................................          12-249  ANSI/UL 122-2007 Standard for   Withdrawn and replaced
                                                         Photographic Equipment--Ed.     with newer version.
                                                         5.0.
12-125................................          12-231  NEMA MS 5-2010, Determination   Withdrawn and replaced
                                                         of Slice Thickness in           with newer version.
                                                         Diagnostic Magnetic Resonance
                                                         Imaging.
12-151................................          12-232  NEMA MS 4-2010, Acoustic Noise  Withdrawn and replaced
                                                         Measurement Procedure for       with newer version.
                                                         Diagnosing Magnetic Resonance
                                                         Imaging Devices.
12-160................................          12-234  NEMA MS 12-2010,                Withdrawn and replaced
                                                         Quantification and Mapping of   with newer version.
                                                         Geometric Distortion for
                                                         Special Applications.
12-162................................          12-235  IEC 60731 Edition 3.0 2011-02,  Withdrawn and replaced
                                                         Amendment 1, Medical            with newer version.
                                                         electrical equipment--
                                                         Dosimeters with ionization
                                                         chambers as used in
                                                         radiotherapy.
12-178................................          12-236  IEC 60601-2-45 Edition 3.0      Newer version with
                                                         2011-02, Medical electrical     transition period.
                                                         equipment--Part 2-45:
                                                         Particular requirements for
                                                         the basic safety and
                                                         essential performance of
                                                         mammographic X-ray equipment
                                                         and mammographic stereotactic
                                                         devices.
12-191................................          12-237  IEC 62359 Edition 2.0 2010-10,  Withdrawn and replaced
                                                         Ultrasonics--Field              with newer version.
                                                         characterization--Test
                                                         methods for the determination
                                                         of thermal and mechanical
                                                         indices related to medical
                                                         diagnostic ultrasonic fields.
12-218................................          12-238  NEMA PS 3.1-3.20 (2011),        Withdrawn and replaced
                                                         Digital Imaging and             with newer version.
                                                         Communications in Medicine
                                                         (DICOM) Set.
----------------------------------------------------------------------------------------------------------------
                                             N. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-11.................................           13-30  CLSI AUTO3-A2 Laboratory        Withdrawn and replaced
                                                         Automation: Communications      with newer version.
                                                         with Automated Clinical
                                                         Laboratory Systems,
                                                         Instruments, Devices, and
                                                         Information Systems; Approved
                                                         Standard, Second Edition 2009.
----------------------------------------------------------------------------------------------------------------
                                                  O. Sterility
----------------------------------------------------------------------------------------------------------------
14-135................................  ..............  AAMI/ANSI ST63:2002,            Withdrawn, see 14-339.
                                                         Sterilization of health care
                                                         products--Requirements for
                                                         the development, validation
                                                         and routine control of an
                                                         industrial sterilization
                                                         process for medical devices--
                                                         Dry heat.

14-169................................  ..............  ASTM F2391-05 (Reapproved       Reaffirmation.
                                                         2011) Standard Test Method
                                                         for Measuring Package and
                                                         Seal Integrity Using Helium
                                                         as the Tracer Gas.
14-170................................          14-313  ASTM F2475-11 Standard Guide    Withdrawn and replaced
                                                         for Biocompatibility            with newer version.
                                                         Evaluation of Medical Device
                                                         Packaging Materials.
14-181................................  ..............  ANSI/AAMI ST58:2005/(R)2010     Reaffirmation and
                                                         Chemical sterilization and      contact person.
                                                         high-level disinfection in
                                                         health care facilities.
14-193................................  ..............  ANSI/AAMI/ISO 11607-1:2006/     Reaffirmation.
                                                         (R)2010 Packaging for
                                                         terminally sterilized medical
                                                         devices--Part 1: Requirements
                                                         for materials, sterile
                                                         barrier systems, and
                                                         packaging systems.
14-194................................  ..............  ANSI/AAMI/ISO 11607-2:2006/     Reaffirmation.
                                                         (R)2010 Packaging for
                                                         terminally sterilized medical
                                                         devices--Part 2: Validation
                                                         requirements for forming,
                                                         sealing, and assembly
                                                         processes.
14-195................................  ..............  ANSI/AAMI/ISO 11140-            Reaffirmation, extent of
                                                         1:2005(R)2010 Sterilization     recognition, and type
                                                         of health care products--       of standard.
                                                         Chemical indicators--Part 1:
                                                         General requirements.
14-201................................  ..............  ANSI/AAMI ST77:2006/(R)2010     Reaffirmation and
                                                         Containment devices for         contact person.
                                                         reusable medical device
                                                         sterilization.
14-214................................  ..............  AOAC 6.2.04:2009 Official       Reaffirmation.
                                                         Method 955.15, Testing
                                                         Disinfectants Against
                                                         Staphylococcus aureus, Use--
                                                         Dilution Method.
14-216................................  ..............  AOAC 6.2.06:2009 Official       Reaffirmation.
                                                         Method 964.02, Testing
                                                         Disinfectants Against
                                                         Pseudomonas aeruginosa, Use--
                                                         Dilution Method.
14-219................................  ..............  AOAC 6.3.06:2008 Official       Reaffirmation.
                                                         Method 965.12, Tuberculocidal
                                                         Activity of Disinfectants.
14-222................................  ..............  ANSI/AAMI/ISO 18472:2006/       Reaffirmation, and
                                                         (R)2010 Sterilization of        contact person.
                                                         health care products--
                                                         Biological and chemical
                                                         indicators--Test equipment.
14-225................................  ..............  ANSI/AAMI/ISO 11137-2:2006      Extent of recognition
                                                         Sterilization of health care    and relevant guidance.
                                                         products--Radiation--Part 2:
                                                         Establishing the
                                                         sterilization dose.
14-227................................  ..............  ANSI/AAMI/ISO 11737-1:2006      Extent of recognition
                                                         Sterilization of health care    and title.
                                                         products--Microbiological
                                                         methods--Part 1:
                                                         Determination of the
                                                         population of microorganisms
                                                         on product.
14-228................................  ..............  ANSI/AAMI/ISO 11135-1:2007      Extent of recognition.
                                                         Sterilization of health care
                                                         products--Ethylene oxide--
                                                         Part 1: Requirements for
                                                         development, validation, and
                                                         routine control of a
                                                         sterilization process for
                                                         medical devices.
14-238................................  ..............  ANSI/AAMI/ISO 11140-5:2007,     Relevant guidance.
                                                         Sterilization of health care
                                                         products--Chemical
                                                         indicators--Part 5: Class 2
                                                         indicators for Bowie and Dick-
                                                         type air removal tests.
14-261................................  ..............  ANSI/AAMI/ISO 17665-1:2006      Extent of recognition,
                                                         Sterilization of health care    relevant guidance and
                                                         products--Moist heat--Part 1:   contact person.
                                                         Requirements for the
                                                         development, validation, and
                                                         routine control of a
                                                         sterilization process for
                                                         medical devices.
14-274................................  ..............  ANSI/AAMI/ISO 15882:2008        Extent of recognition.
                                                         Sterilization of health care
                                                         products--Chemical
                                                         indicators--Guidance for
                                                         selection, use, and
                                                         interpretation of results.
14-276................................          14-314  ANSI/AAMI ST67:2011             Withdrawn and replaced
                                                         Sterilization of health care    with newer version.
                                                         products--Requirements and
                                                         guidance for selecting a
                                                         sterility assurance level
                                                         (SAL) for products labeled
                                                         ``sterile''.
14-285................................  ..............  ANSI/AAMI/ISO 14161:2009        Title, contact person.
                                                         Sterilization of health care
                                                         products--Biological
                                                         indicators--Guidance for the
                                                         selection, use and
                                                         interpretation of results.
14-287................................  ..............  ANSI/AAMI/ISO 11737-2:2009      Extent of recognition
                                                         Sterilization of medical        and title.
                                                         devices--Microbiological
                                                         methods--Part 2: Tests of
                                                         sterility performed in the
                                                         definition, validation and
                                                         maintenance of a
                                                         sterilization process.
14-291................................  ..............  ANSI/AAMI/ISO 14937:2009        Extent of recognition.
                                                         Sterilization of health care
                                                         products--General
                                                         requirements for
                                                         characterization of a
                                                         sterilizing agent and the
                                                         development, validation, and
                                                         routine control of a
                                                         sterilization process for
                                                         medical devices.
14-295................................  ..............  ANSI/AAMI ST81:2004/(R)2010,    Relevant guidance and
                                                         Sterilization of medical        contact person.
                                                         devices--Information to be
                                                         provided by the manufacturer
                                                         for the processing of
                                                         resterilizable medical
                                                         devices.
14-296................................  ..............  ANSI/AAMI/ISO 11138-1:2006/     Extent of recognition,
                                                         (R)2010 Sterilization of        contact person and
                                                         health care products--          relevant guidance.
                                                         Biological indicators--Part
                                                         1: General requirements.
14-297................................  ..............  ANSI/AAMI/ISO 11137-1:2006/     Extent of recognition,
                                                         (R)2010 Sterilization of        and relevant guidance.
                                                         health care products--
                                                         Radiation--Part 1:
                                                         Requirements for development,
                                                         validation, and routine
                                                         control of a sterilization
                                                         process for medical devices.
14-298................................  ..............  ANSI/AAMI/ISO 11137-3:2006/     Extent of recognition
                                                         (R)2010 Sterilization of        and relevant guidance.
                                                         health care products--
                                                         Radiation--Part 3: Guidance
                                                         on dosimetric aspects.
14-301................................          14-315  USP 34:2011 <61>                Withdrawn and replaced
                                                         Microbiological Examination     with newer version.
                                                         of Nonsterile Products:
                                                         Microbial Enumeration Tests.
14-302................................          14-316  USP 34:2011 <71> Sterility      Withdrawn and replaced
                                                         Tests.                          with newer version.

14-303................................          14-317  USP 34:2011 <85> Bacterial      Withdrawn and replaced
                                                         Endotoxins Test.                with newer version.
14-304................................          14-318  USP 34:2011 <151> Pyrogen Test  Withdrawn and replaced
                                                         (USP Rabbit Test).              with newer version.
14-305................................          14-319  USP 34:2011 <161> Transfusion   Withdrawn and replaced
                                                         and Infusion Assemblies and     with newer version.
                                                         Similar Medical Devices.
14-306................................          14-320  USP 34:2011 Biological          Withdrawn and replaced
                                                         Indicator for Steam             with newer version.
                                                         Sterilization--Self Contained.
14-307................................          14-321  USP 34:2011 Biological          Withdrawn and replaced
                                                         Indicator for Dry-Heat          with newer version.
                                                         Sterilization, Paper Carrier.
14-308................................          14-322  USP 34:2011 Biological          Withdrawn and replaced
                                                         Indicator for Ethylene Oxide    with newer version.
                                                         Sterilization, Paper Carrier.
14-309................................          14-323  USP 34:2011 Biological          Withdrawn and replaced
                                                         Indicator for Steam             with newer version.
                                                         Sterilization, Paper Carrier.
14-310................................          14-324  USP 34:2011 <62>                Withdrawn and replaced
                                                         Microbiological Examination     with newer version.
                                                         of Nonsterile Products: Tests
                                                         for Specified Microorganisms.
----------------------------------------------------------------------------------------------------------------
                                              P. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-7..................................           15-27  ASTM F2315-11 Standard Guide    Withdrawn and replaced
                                                         for Immobilization or           with newer version.
                                                         Encapsulation of Living Cells
                                                         or Tissue in Alginate Gels.
15-8..................................  ..............  ASTM F2064-00 (Reapproved       Editorial change.
                                                         2006) \1\ Standard Guide for
                                                         Characterization and Testing
                                                         of Alginates as Starting
                                                         Materials Intended for Use in
                                                         Biomedical and Tissue-
                                                         Engineered Medical Products
                                                         Application.
15-10.................................  ..............  ASTM F2451-05 (Reapproved       Reaffirmation.
                                                         2010) Standard Guide for in
                                                         vivo Assessment of
                                                         Implantable Devices Intended
                                                         to Repair or Regenerate
                                                         Articular Cartilage.
15-12.................................           15-28  ASTM F2103-11 Standard Guide    Withdrawn and replaced
                                                         for Characterization and        with newer version.
                                                         Testing of Chitosan Salts as
                                                         Starting Materials Intended
                                                         for Use in Biomedical and
                                                         Tissue-Engineered Medical
                                                         Product Applications.
15-15.................................           15-29  ASTM F2259-10 Standard Test     Withdrawn and replaced
                                                         Method for Determining the      with newer version.
                                                         Chemical Composition and
                                                         Sequence in Alginate by
                                                         Proton Nuclear Magnetic
                                                         Resonance (1H NMR)
                                                         Spectroscopy.
15-18.................................           15-30  ASTM F2212-11 Standard Guide    Withdrawn and replaced
                                                         for Characterization of Type    with newer version.
                                                         I Collagen as Starting
                                                         Material for Surgical
                                                         Implants and Substrates for
                                                         Tissue Engineered Medical
                                                         Products (TEMPs).
15-25.................................           15-31  ASTM F2312-11 Standard          Withdrawn and replaced
                                                         Terminology Relating to         with newer version.
                                                         Tissue Engineered Medical
                                                         Products.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.

    In table 3 of this document, FDA provides the listing of new
entries and consensus standards added as modifications to the list of
recognized standards under Recognition List Number: 028.

        Table 3--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
                                                            Reference
        Recognition No.          Title of standard \1\   Number and date
------------------------------------------------------------------------
                           A. Biocompatibility
------------------------------------------------------------------------
2-173.........................  Biological evaluation   ANSI/AAMI/ISO
                                 of medical devices--    10993-10:2010.
                                 Part 10: Tests for
                                 irritation and skin
                                 sensitization.
2-175.........................  Biological evaluation   ISO 10993-3
                                 of medical devices      Second edition
                                 Part 3: Tests for       2003-10-15.
                                 genotoxicity,
                                 carcinogenicity and
                                 reproductive toxicity.
2-176.........................  Biological evaluation   ISO 10993-11
                                 of medical devices      Second edition
                                 Part 11: Tests for      2006-08-15.
                                 systemic toxicity.
2-177.........................  Biological evaluation   ISO 10993-6
                                 of medical devices--    Second edition
                                 Part 6: Tests for       2007-04-15.
                                 local effects after
                                 implantation.
2-178.........................  Biological evaluation   ISO 10993-12
                                 of medical devices--    Third edition
                                 Part 12: Sample         2007-11-15
                                 preparation and         Corrected
                                 reference materials.    version 2008-02-
                                                         15.
2-179.........................  Biological evaluation   ISO 10993-1
                                 of medical devices--    Fourth edition
                                 Part 1: Evaluation      2009-10-15.
                                 and testing within a
                                 risk management
                                 process.
2-181.........................  Clinical investigation  ANSI/AAMI/ISO
                                 of medical devices      14155:2011.
                                 for human subjects--
                                 Good clinical
                                 practice.

2-182.........................  Clinical investigation  ISO 14155 Second
                                 of medical devices      edition 2011-02-
                                 for human subjects--    01.
                                 Good clinical
                                 practice.
2-183.........................  Clinical investigation  ISO 14155: 2011
                                 of medical devices      Technical
                                 for human subjects--    Corrigendum 1
                                 Good clinical           Published 2011-
                                 practice TECHNICAL      07-15.
                                 CORRIGENDUM 1.
------------------------------------------------------------------------
                            B. Cardiovascular
------------------------------------------------------------------------
3-96..........................  Non-invasive            ISO 81060-1
                                 sphygmomanometers--Pa   First edition
                                 rt 1: Requirements      2007-12-01.
                                 and test methods for
                                 non-automated
                                 measurement type.
3-97..........................  Non-invasive            ISO 81060-2
                                 sphygmomanometers--Pa   First edition
                                 rt 2: Clinical          2009-05-01.
                                 validation of
                                 automated measurement
                                 type.
3-98..........................  Non-invasive            ISO 81060-2:2009
                                 sphygmomanometers--Pa   TECHNICAL
                                 rt 2: Clinical          CORRIGENDUM 1
                                 validation of           Published 2011-
                                 automated measurement   02-15.
                                 type TECHNICAL
                                 CORRIGENDUM 1.
3-99..........................  Evaluation of           AAMI TIR42:2010.
                                 particulates
                                 associated with
                                 vascular medical
                                 devices.
3-100.........................  Medical electrical      ANSI/AAMI/IEC
                                 equipment--Part 2-27:   60601-2-27:2011
                                 Particular              .
                                 requirements for the
                                 basic safety and
                                 essential performance
                                 of
                                 electrocardiographic
                                 monitoring equipment.
------------------------------------------------------------------------
                               C. General
------------------------------------------------------------------------
5-68..........................  Medical devices--       ANSI/AAMI/ISO
                                 Symbols to be used      15223-2:2010.
                                 with medical device
                                 labels, labelling,
                                 and information to be
                                 supplied--Part 2:
                                 Symbol development,
                                 selection and
                                 validation.
5-69..........................  Medical electrical      IEC 60601-1-11
                                 equipment--Part 1-11:   (First edition--
                                 General requirements    2010) April
                                 for basic safety and    2011.
                                 essential
                                 performance--Collater
                                 al Standard:
                                 Requirements for
                                 medical electrical
                                 equipment and medical
                                 electrical systems
                                 used in the home
                                 healthcare
                                 environment
                                 Corrigendum 1.
5-70..........................  Medical devices--       ANSI/AAMI/ISO
                                 Application of risk     14971:2007/
                                 management to medical   (R)2010.
                                 devices.
------------------------------------------------------------------------
               D. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
6-263.........................  Absorbable Surgical     USP 34-NF 28
                                 Suture.                 2011.
6-264.........................  Sterile, single-use     ISO 10555-1
                                 intravascular           First edition
                                 catheters--Part 1:      1995-06-15
                                 General requirements.   Amendment 1
                                                         1999-07-15.
6-265.........................  Sterile, single-use     ISO 10555-1
                                 intravascular           First edition
                                 catheters--Part 1:      1995-06-15
                                 General requirements.   AMENDMENT 2
                                                         2004-05-15.
6-268.........................  Standard Terminology    ASTM F921--10
                                 Relating to             (Reapproved
                                 Hemostatic Forceps.     2011).
6-269.........................  Standard Terminology    ASTM F1078--10
                                 for Surgical            (Reapproved
                                 Scissors--Inserted      2011).
                                 and Non-Inserted
                                 Blades.
6-270.........................  Standard Terminology    ASTM F1840-10
                                 for Surgical Suture     \1\.
                                 Needles.
6-271.........................  Standard Test Method    ASTM F1874--98
                                 for Bend Testing of     (Reapproved
                                 Needles Used in         2011).
                                 Surgical Sutures.
6-272.........................  Standard Specification  ASTM F2062--00
                                 for Square Drive        (Reapproved
                                 Interconnections on     2011).
                                 Surgical Instruments.
6-273.........................  Sharps injury           ISO 23908 First
                                 protection--Requireme   edition 2011-06-
                                 nts and test methods--  11.
                                 Sharps protection
                                 features for single-
                                 use hypodermic
                                 needles, introducers
                                 for catheters and
                                 needles used for
                                 blood sampling.
------------------------------------------------------------------------
                         E. In Vitro Diagnostics
------------------------------------------------------------------------
7-225.........................  Validation and          CLSI GP34-A.
                                 Verification of Tubes
                                 for Venous and
                                 Capillary Blood
                                 Specimen Collection;
                                 Approved Guideline.
7-226.........................  Quality Management      CLSI GP26-A4.
                                 System: A Model for
                                 Laboratory Services;
                                 Approved Guideline--
                                 Fourth Edition.
7-227.........................  Criteria for            CLSI M53-A.
                                 Laboratory Testing
                                 and Diagnosis of
                                 Human
                                 Immunodeficiency
                                 Virus Infection;
                                 Approved Guideline.