title: Tin Cup

text: Roger Ebert of the "Chicago Sun-Times" gave the film 3 out of 4 and wrote: "Well written. The dialogue is smart and fresh." Todd McCarthy of "Variety" magazine wrote: "Amiable and constantly amusing rather than uproarious, this mangy tale of a ne'er-do-well's fitful assault on personal and professional respectability benefits greatly from Kevin Costner's ingratiatingly comic star turn, his most appealing work in years."


title: Methyl isocyanate

text: Methyl isocyanate (MIC) is an organic compound with the molecular formula CHNCO. Synonyms are isocyanatomethane and methyl carbylamine. Methyl isocyanate is an intermediate chemical in the production of carbamate pesticides (such as carbaryl, carbofuran, methomyl, and aldicarb). It has also been used in the production of rubbers and adhesives. As an extremely toxic and irritating compound, it is very hazardous to human health. It was the principal toxicant involved in the infamous Bhopal gas disaster, which officially killed around 20,000 people in total. It is also a very potent lachrymatory agent.


title: Methyl isocyanate

text: Methyl isocyanate is a colorless, poisonous, lachrymatory (tearing agent), flammable liquid. It is soluble in water to 6–10 parts per 100 parts, but it also reacts with water (see Reactions below).


title: Methyl isocyanate

text: Methyl isocyanate is usually manufactured by the reaction of monomethylamine and phosgene. For large scale production, it is advantageous to combine these reactants at higher temperature in the gas phase. A mixture of methyl isocyanate and two moles of hydrogen chloride is formed, but N-methylcarbamoyl chloride (MCC) forms as the mixture is condensed, leaving one mole of hydrogen chloride as a gas.


title: Methyl isocyanate

text: The methyl isocyanate is obtained by treating the MCC with a tertiary amine, such as N,N-dimethylaniline, or with pyridine or by separating it by using distillation techniques.


title: Methyl isocyanate

text: Methyl isocyanate is also manufactured from N-methylformamide and air. In the latter process, it is immediately consumed in a closed-loop process to make methomyl. Other manufacturing methods have been reported.


title: Methyl isocyanate

text: Methyl isocyanate reacts readily with many substances that contain N-H or O-H groups. With water, it forms 1,3-dimethylurea and carbon dioxide with the evolution of heat (1358.5 joules, or 325 calories, per gram of MIC):


title: Methyl isocyanate

text: At 25 °C, in excess water, half of the MIC is consumed in 9 min.; if the heat is not efficiently removed from the reacting mixture, the rate of the reaction will increase and rapidly cause the MIC to boil. Such a reaction triggered the Bhopal disaster after that water was accidentally introduced in a MIC storage tank during cleaning operation of an adjacent pipe without closing the proper isolation valve of the reservoir. The consequence of the out of control exothermic process was a runaway reaction and the direct release of 42 tons of MIC to the atmosphere.


title: Methyl isocyanate

text: If MIC is in excess, 1,3,5-trimethylbiuret is formed along with carbon dioxide. Alcohols and phenols, which contain an O-H group, react slowly with MIC, but the reaction can be catalyzed by trialkylamines or dialkyltin dicarboxylate. Oximes, hydroxylamines, and enols also react with MIC to form methylcarbamates. These reactions produce the products described below (Uses).


title: Methyl isocyanate

text: Ammonia, primary, and secondary amines rapidly react with MIC to form substituted ureas. Other N-H compounds, such as amides and ureas, react much more slowly with MIC.


title: Methyl isocyanate

text: It also reacts with itself to form a trimer or higher molecular weight polymers. In the presence of catalysts, MIC reacts with itself to form a solid trimer, trimethyl isocyanurate, or a higher molecular weight polymer:


title: Methyl isocyanate

text: Sodium methoxide, triethyl phosphine, ferric chloride and certain other metal compounds catalyze the formation of the MIC-trimer, while the high-molecular-weight polymer formation is catalyzed by certain trialkylamines. Since the formation of the MIC trimer is exothermic (1246 joules, or 298 calories, per gram of MIC), the reaction can lead to violent boiling of the MIC. The high-molecular-weight polymer hydrolyzes in hot water to form the trimethyl isocyanurate. Since catalytic metal salts can be formed from impurities in commercial grade MIC and steel, this product must not be stored in steel drums or tanks.


title: Methyl isocyanate

text: Methyl isocyanate is extremely toxic. There is no known antidote. The threshold limit value set by the American Conference of Governmental Industrial Hygienists is 0.02 ppm. MIC is toxic by inhalation, ingestion and contact in quantities as low as 0.4 ppm. Exposure symptoms include coughing, chest pain, dyspnea, asthma, irritation of the eyes, nose and throat, as well as skin damage. Higher levels of exposure, over 21 ppm, can result in pulmonary or lung edema, emphysema and hemorrhages, bronchial pneumonia and death. Although the odor of methyl isocyanate cannot be detected at 5 ppm by most people, its potent lachrymal properties provide an excellent warning of its presence (at a concentration of 2–4 parts per million (ppm) subject's eyes are irritated, while at 21 ppm, subjects could not tolerate the presence of methyl isocyanate in air).


title: Methyl isocyanate

text: Proper care must be taken to store methyl isocyanate because of its ease of exothermically polymerizing (see Reactions) and its similar sensitivity to water. Only stainless steel or glass containers may be safely used; the MIC must be stored at temperatures below and preferably at .


title: Methyl isocyanate

text: The toxic effect of the compound was apparent in the 1984 Bhopal disaster, when around of methyl isocyanate and other gases were released from the underground reservoirs of the Union Carbide India Limited (UCIL) factory, over a populated area on 3 December 1984, killing about 3,500 people immediately and 15,000 more over the next several years.


title: Methyl isocyanate

text: During structural fires, natural materials can contribute to releasing isocyanates including methyl isocyanate.


title: Methyl isocyanate

text: Until recent decades, the mechanism of methyl isocyanate toxicity in humans was largely unknown or unclear. Methyl isocyanate and other isocyanates are electrophiles and are currently thought to cause toxicity by the alkylation of biomolecules. The mechanism of methyl isocyanate was previously suspected to be the carbamylation of hemoglobin which would interfere with its oxygen binding capability causing hypoxia. However, experiments showed that when rats and guinea pigs were exposed to methyl isocyanate at concentrations above the median lethal concentration (LC, the concentration sufficient to kill 50% of the tested population), only 2% of hemoglobin molecules were carbamylated, suggesting that this is probably not the mechanism of toxicity.


title: Methyl isocyanate

text: On 30 July 2015, scientists reported that upon the first touchdown of the "Philae" lander on comet 67/P surface, measurements by the COSAC and Ptolemy instruments revealed sixteen organic compounds, four of which were seen for the first time on a comet, including acetamide, acetone, methyl isocyanate and propionaldehyde.


title: Methyl isocyanate

text: In 2017, two teams of astronomers using the Atacama Large Millimeter Array (ALMA) interferometer made of 66 radio telescopes in the Atacama Desert (northern Chile) have discovered the presence of MIC around young Sun-like stars.


title: Methyl isocyanate

text: MIC is considered a prebiotic molecule as explained by the discoverers of the ALMA findings in IRAS 16293-2422, a multiple system of very young stars: "This family of organic molecules is involved in the synthesis of peptides and amino acids, which, in the form of proteins, are the biological basis for life as we know it".


title: Honda Shadow

text: The Honda Shadow refers to a family of cruiser-type motorcycles made by Honda since 1983. The Shadow line features motorcycles with a liquid-cooled 45 or 52-degree V-twin engine ranging from 125 to 1,100 cc engine displacement. The 250 cc Honda Rebel is associated with the Shadow line in certain markets.


title: Honda Shadow

text: In 1983, Honda introduced the Shadow series of motorcycles in an attempt to address the needs of the American cruiser market with the VT500c and VT750c. However, due to tariff restrictions in the United States on imported Japanese bikes over 701 cc, the VT750c was reduced to 700 cc in 1984 and was sold as the Vt700c. In 1985, the tariff was lifted and the line soon expanded to an 1,100 cc bike the VT1100c. The VT750c was replaced by an 800 cc version the VT800c in 1988.


title: Honda Shadow

text: The VT600c was launched in 1988 as Honda's new entry level Shadow though still slotted above the Honda Rebel. The line changed little until the introduction of the 750 cc Honda Shadow Ace in 1997. From 2000 to 2007, the Honda Shadow Sabre replaced the VT1100 until the 1,100 cc class was discontinued in favor of the new VTX line, specifically the 1,300 cc offering known as the VTX1300. As of 2011, the Shadow brand has been limited to a single 750 cc cruiser available in Spirit, Aero, Phantom, and RS trims. All other offers are known under the VTX or Rebel brands.


title: Honda Shadow

text: The RS and Phantom are the 2 latest additions to the 750 cc line-up from year 2010. Both are Fuel injected. Shadow RS recalls a flat track racing bike with chain drive, a 'peanut' style gas tank and a slightly higher seat height ( 29 inches ) with foot pegs less forward than conventional cruisers ( meaning a more standard seating position). Phantom is more like a conventional cruiser in ergonomics.


title: Honda Shadow

text: The Honda 125 is mainly for the UK and Europe market, as it fits within the restrictions placed on learner drivers in the UK and the light motorcycle license in Europe. It also has a chain drive instead of a shaft drive seen on the larger engined bikes. Sales ended in 2009.


title: Honda Shadow

text: The 500cc "VT500C" introduced in 1983 featured chrome side covers and black engine covers. The headlight was chrome and rectangular and had a single horn. The engine was the Honda VT500, a OHC three-valve, liquid cooled V-Twin that averaged around 51.7MPG and put out 54HP@9,000RPM and 31 ft-Ib of torque @7,000RPM and mated to a six-speed, shaft drive transmission.


title: Honda Shadow

text: In 1984, The "VT500C' was featured include the fuel tank and rear fenders painted the same. The front fender is chrome and this year the side covers and engine covers were painted black. The headlight was chrome and rectangular and there was a single horn. The engine is virtually the same as the 1983 model.


title: Honda Shadow

text: The 1985 "VT500C" had round and chromed headlamps. This model continued with the dual horns. A two piece seat with an integrated backrest was incorporated. Starting this year, the engine covers were polished chrome and the fins enlarged. The "Honda" tank decal was curved instead of straight.


title: Honda Shadow

text: The "VLX" "Shadow 600" (aka "VT600C") was introduced as a new model in 1988. It has a single shock rear suspension, a low seat height and a long wheelbase with a fuel tank. The engine is a SOHC three-valve liquid cooled 52-degree V-Twin that averaged 49.5MPG and unlike prior models this engine utilized a shared crankpin to have a more Harley Davidson-like sound & shake thus generating a low 39HP @6,500rpm and 36 ft-Ib of torque @3,500RPM connected to a four-speed transmission and chain drive. In 1993 the dual Keihin CV carburetors were replaced by a single vertical Keihin CV carburetor more like the single carbs found on Harley Davidsons via different heads and a special intake manifold again like many Harley Davidsons, this further reduced horsepower from 39 hp down to 35 hp.


title: Honda Shadow

text: In 1989, The VLX VT600C remained largely the same. The VT600C was not made in 1990 but did make a comeback in 1991 offered only in black. The engine and body style was retained from the 1991 model year.


title: Honda Shadow

text: A new deluxe version "VT600CD" introduced in 1993 added more chrome on the engine cases and valve covers. The seat on the deluxe version is soft and tucked. By 1994 the Deluxe model was a standard offering for every year the VLX was made.


title: Honda Shadow

text: A 1983 model year 750cc V-twin motorcycle is the senior member in the large family of Honda cruisers (of various sizes) named "Shadow". As of 2018 the once-extensive Shadow line has been reduced to two successors of that original model, the "Shadow Aero 750" and the "Shadow Phantom 750". Even after multiple engine redesigns the current Shadow 750 still uses the same general layout as the 1983 motor: 4-stroke liquid-cooled narrow-angle V-twin, SOHC three-valve cylinder heads with dual spark plugs.


title: Honda Shadow

text: The VT750C "Shadow debuted in late 1982 for North American markets, and a nearly identical NV750 "Custom launched in Japan for Honda's domestic market. Both were propelled by a new 750 cc liquid-cooled four-stroke dual-carburetor SOHC three-valve 45-degree V-twin engine with a six-speed transmission and shaft final drive. The Honda identification code for this type of engine is RC14E.


title: Honda Shadow

text: In a January 1983 road test, "Cycle" said: "This 750 twin is built around what is arguably the most technologically sophisticated Vee ever designed." Advanced technology included three-valve two-plug combustion chambers and a vibration-canceling offset dual-pin crankshaft, as well as hydraulic valve adjusters to keep the valvetrain running at effectively zero-clearance while also eliminating routine adjustments. Each cylinder head had a single chain-driven camshaft and an individual downdraft CV carburetor. Engineering innovations appeared in the transmission as well. The clutch was actuated hydraulically rather than through a mechanical cable; a diaphragm clutch spring was used instead of more common coil springs and a slipper clutch eliminated rear-wheel hop during engine braking or quick downshifting.


title: Honda Shadow

text: In addition to the V-engine, the Shadow's frame and body incorporated classic American cruiser styling cues: a teardrop fuel tank (with a hidden sub-tank to increase capacity), a low height two-piece seat with sissy bar and backrest, cruiser handlebar, cast wheels, chrome front fender, a round head lamp and instrument casings, large rake angle and angle-cut mufflers. In the US market 1983 was the only model year for the VT750C Shadow, which was available in two colors, Black and Candy Wineberry Red. The VT750C remained available in Canada for the 1984 and 1985 model years nearly unchanged, apart from color, from the 1983 model.


title: Honda Shadow

text: For the 1986 model year, Japan's NV750C was renamed "Honda Shadow" as part of appearance and frame updates, including a lower seat, longer wheelbase, increased rake and trail as well as a rod linkage for the rear brake (previously cable operated). Cast wheels were changed from ten spokes to five. Gold color was added to wheels, crankcase cover and headlight trim. The NV750C Shadow continued to use the RC14E motor. Canadian VT750C models for 1986 were updated in the same manner as the NV750C. The Shadow 750 was exported to Germany in 1987, the last VT750C model year.


title: Honda Shadow

text: The VT700C "Shadow" is among a class of motorcycles (including 700cc Honda Sabre and Magna models) known as "tariff-busters." Honda introduced the Shadow 700cc model in 1984 exclusively for the US market in response to tariffs (to protect Harley-Davidson) on Japanese motorcycles with engines over 700cc. Honda took the RC14E 45-degree V-twin and reduced its bore size by to create the smaller displacement RC19E engine which was not subject to the import tariff.


title: Honda Shadow

text: The VT700C for 1984 was available in either Black or Candy Scorpio Red; for 1985 the color choices were Black or Candy Glory Red. Both years had painted side covers with a "Shadow 700" decal.


title: Honda Shadow

text: For 1986 Honda altered the frame and appearance of the VT700C (as with the Canadian and Japanese 750 models) which included lowering the seat, stretching the wheelbase, increasing rake and trail, switching the front brake from dual disks to a single disk and replacing ten-spoke with five-spoke cast wheels. The new frame was designed to suppress engine vibrations, and a new camshaft improved low-rpm performance with a slight reduction in peak power. The engine was no longer painted black, the front fender was painted instead of chrome plated, and side covers were chrome instead of paint. Side covers displayed the single word "Shadow" and Honda's wing logotype was showcased on the tank. The passenger backrest was eliminated. Color schemes for 1986 were either Black or Candy Brilliant Red and then Black or Candy Glory for 1987, last model year for the VT700C.


title: Honda Shadow

text: Honda introduced the VT800C "Shadow" for 1988, the sixth year of the Shadow series. The 800cc engine had the same bore diameter as the original Shadow 750 engine, and a longer stroke, but was otherwise the same SOHC, three valves per cylinder, 45-degree V-twin engine. Besides having a larger displacement, this new RC32E engine did have another significant difference – it had a four-speed transmission. The VT800c ran on spoke-and-rim wheels that required tube-type tires instead of the tubeless tires used on the earlier models with cast wheels.


title: Honda Shadow

text: The 1988 Shadow 800 had a new look, with more chrome plating along with two-toned paint on the fuel tank and fenders. Color combinations were Black and Candy Glory Red, or Candy Wineberry Red and Dry Silver Metallic. The tank also wore a simple "Shadow" decal, rather than the Honda wing. The VT800C was produced only for the North American market, and only for the 1988 model year.


title: Honda Shadow

text: Honda brought out a new engine for the VT750C "Shadow ACE" in 1997 (the ACE or A.C.E. designation, for "American Classic Edition", was used only in North America). The RC44E engine had its origin in the 600cc Shadow VLX 52-degree V-twin, enlarged to 750cc by means of a wider bore and a longer stroke. This new engine was similar to the old (RC14E) Shadow 750 in that it had liquid cooling and SOHC three-valve dual-plug combustion chambers, conversely, it lacked hydraulically adjusted valves, offset crankpins and a slipper clutch. The shared crankpin limited these engines to 43 hp @ 5500rpm and 44ftlb @ 3000rpm. Further changes to the drivetrain included a wide-ratio five-speed gearbox (down from six) and a chain final drive instead of shaft. Engine intake was through dual CV carburetors, with Secondary air injection on the exhaust side for emissions control.


title: Honda Shadow

text: The VT750C Shadow ACE had full fenders and retro style features similar to the VT1100C Shadow ACE released two years earlier. A chrome plated exhaust had the look of a two-into-one system, but each header pipe had separate channel inside the large muffler, exiting through two tailpipes. North American models had an electronic speedometer and idiot lights mounted on the handlebar, while models for the European and other market had them mounted on the fuel tank. The Shadow 750 was available as a standard or Deluxe model with more chrome (VT750CD) and optional two-tone paint. The 750cc Shadow was also available in Japan as the NV750C (and as a nearly identical Shadow 400cc model) continuing through 2001. The NV750C was also available in South Korea from 1999 to 2001.


title: Honda Shadow

text: 1998 through 2000 models of the VT750C continued with annual color changes. From 2001, North American models had the speedometer mounted on the tank (the same as European and Australian versions). The 750cc Shadow ACE was the best-selling model in Honda's 2002 street motorcycle lineup. For 2002 and 2003, rather than the standard VT750C standard model, Honda manufactured only VT750CD (Deluxe) or VT750DC (Spirit) models.


title: Honda Shadow

text: For the 2001 model year, Honda added a slightly modified version of the VT750C to the Shadow line, the VT750DC "Shadow Spirit (North American models, Shadow Black Widow in Europe) with lower gearing and street-rod or chopper style bodywork. The VT750DC Shadow was exported to Australia, and Honda's domestic market version was the NV750DC "Shadow Slasher.


title: Honda Shadow

text: Although the frame and body were new, VT750DC and NV750DC models used the existing RC44E motor with dual CV carburetors. Distinguishing features were a narrower front tire on a 19-inch wheel, slim front fender and a bobbed rear fender. Honda manufactured the VT750DC Shadow Spirit through the 2003 model year, skipped 2004, then resumed production in 2005‑2007 for North America. The last model year for the VT750DC overlapped with its shaft-drive replacement, the 2007 VT750C2 Shadow Spirit.


title: Honda Shadow

text: Honda announced in 2009 that they would produce a roadster version of the Shadow 750 with chain final drive. Honda Motor Co. originally designed the VT750S, powered by the RC58E fuel-injected 52° V-twin, for their domestic market. Nonetheless, the made-in-Japan VT750S was exported to Europe as well as Australia and New Zealand.


title: Honda Shadow

text: At the request of American Honda, this new model was also exported to North America as the VT750RS ("Retro Standard"). With the arrival of the VT750RS in 2010, there were four concurrent models in the Shadow 750 lineup: the fuel-injected RS and Phantom, in addition to the carbureted (in North America) Spirit and Aero. Honda kept the Shadow RS on the roster for four model years, from 2010 to 2013 inclusive.


title: Honda Shadow

text: With frame geometry that differed significantly from Shadow cruisers, the VT750S and RS models' footpegs, handlebars and seat put the rider into a neutral, upright posture. The seat height of , for example, was higher than most cruisers and a full above that of the Shadow Phantom. Rake and trail were 32.5 degrees and , 1.5 degrees steeper and approximately less than other Shadows. The VT750RS wheelbase of was about shorter.


title: Honda Shadow

text: The VT750RS had spoked wheels with tube-type tires, 100/90-19 in front and 150/80-16-inch in back. Brakes were a single 296 mm front disc with a twin-piston caliper and a mechanical drum rear.


title: Honda Shadow

text: Several reviewers observed that there was more than a passing resemblance between the VT750RS and Sportster 883 models; Honda's peanut-shaped fuel tank, for instance, emulated classic Sportster tanks. A few road tests included side-by-side comparisons of the Honda and the Harley-Davidson.


title: Honda Shadow

text: For the 2011 model year, the VT750RS was painted in Honda Racing tricolors, evocative of the Honda VFR750R.


title: Honda Shadow

text: At the 2003 Tokyo Motor Show, Honda exhibited a preproduction "low-and-long" 750cc Shadow kitted out in retro-style bodywork, equipped with shaft final drive and the Honda Ignition Security System (HISS) electronic anti-theft device.


title: Honda Shadow

text: Honda dropped the "ACE" and "Spirit" models from the 750cc Shadow line for 2004, manufacturing just the new VT750C "Shadow Aero" model (chain-drive Spirit production restarted in 2005). The reengineered RC50E engine was still a 52-degree, liquid-cooled V-Twin, single-pin crankshaft configuration. SOHC cylinder heads still had two spark plugs and three valves, but were modified to increase the compression ratio. Engine tuning changes de emphasized peak power in favor of torque at low and mid RPMs. A 2‑into‑1 exhaust ended in a large muffler containing separate silencers for each cylinder (similar to that on the 750 ACE) as well as a catalytic converter. The dual CV carburetors of the RC44E motor were replaced by a single CV carburetor on the RC50E. A new steel-tube frame with lower frame rails moved the Aero's seat height further down than either of the models it replaced.


title: Honda Shadow

text: Honda replaced the 2‑into‑1 exhaust with a 2‑into‑2 system for 2008 and subsequent model years, including the 2008‑2009 Shadow Tourer VT750T model equipped with a windscreen, saddlebags and passenger backrest. Except for North America, 2008 VT750C models had programmed fuel injection (PGM-FI) in place of the CV carburetor. Shadow Aero models were given PGM-FI in North America starting with the 2011 model year.


title: Honda Shadow

text: Honda offers anti-lock brake options for the 750cc Shadow Aero. Early VT750CA models had front-wheel ABS only, subsequent VT750CS models replace the rear drum brake with a hydraulic disk brake, required for Honda's combined ABS (C-ABS) with individual control of front and rear brakes. Shadow Aero VT750C and VT750CS models remain in the American Honda line-up for 2019.


title: Honda Shadow

text: In 2007 (the twenty-fifth year of the Shadow line) Honda sold three different Shadow 750 cruisers, the original chain-drive "Spirit", the shaft-drive "Aero" and the first "Spirit "VT750C2. Canadian automotive journalist David Booth said "that the VT750C2 is essentially the mechanicals of the VT750C Aero mated to the styling of the VT750D Spirit, with a few essential tweaks." The C2 model inherited its 750cc engine from the Aero, with a CV carburetor for North America and a PGM-FI throttle body elsewhere.


title: Honda Shadow

text: The VT750C2 Spirit came by its frame layout from the VT750C Aero as well, but Honda's designers adjusted the new Spirit's geometry to give it a drag-bike or chopper-style appearance. A wheelbase stretched to , a rake angle of 34°30' along with noticeable triple-tree offset gave prominence to bare forks and a 21 inch front wheel (a first for Honda cruisers). The chopper look was reinforced by a two-into-two exhaust system and a seat height reduced to .


title: Honda Shadow

text: There were two significant updates to the VT750C2 Spirit. From 2012, North American Spirit models eliminated the carburetor in favor of a PGM-FI throttle body. From 2013, a new Spirit VT750C2S model with antilock front and rear disc brakes (C-ABS) was sold alongside the VT750C2 in the USA and was the only model offered in Europe.


title: Honda Shadow

text: Confusingly, the model code VT750C2 had already been used to identify 1997-2001 European and Australian 750 Shadows with two-tone paint.


title: Honda Shadow

text: The 2010 VT750C2B "Shadow Phantom debuted in Fall 2009 powered by a blackened fuel-injected version (engine code RC53E) of the existing Shadow 750 shaft-drive engine. The Phantom's frame and abridged bodywork, based on the Aero 750, were both painted black. This model was called the Shadow Black Spirit in European markets. Honda Motor Europe described the VT750C2B, called Shadow Black Spirit" in some European markets, a variant of the VT750C2 Shadow Spirit with "authentic bobber styling."


title: Honda Shadow

text: In North America, the 2010 model year marked the arrival of PGM-FI equipped Shadow 750 engines, in both Phantom and VT750RS models.


title: Honda Shadow

text: Honda and NHTSA issued a January 2016 recall for 2010 through 2016 VT750C/CA/CS, VT750C2/ C2F/C2S, and VT750C2B models. The NHTSA announcement said that “engine vibration may cause the bank angle sensor wire to rub on the wire harness joint connector, resulting in a loss of the sensor signal.” Honda Motor Company had received reports, dating back to 2013, of engine stall or misfire incidents resulting from bank angle sensor failure.


title: Honda Shadow

text: Honda Japan created a series of models for the Japanese domestic market in 1997, practically identical to the VT750 series but with smaller displacement engines. Among these was the Shadow Slasher, introduced in February 2000. From 2009, Honda Australia imports the VT400 as a Learner Approved Motorcycle alongside the popular VT750.


title: Honda Shadow

text: The V-Twin 1100 (VT1100) was introduced by Honda in 1985 and was in continuous production till 2007.<br>


title: Honda Shadow

text: All models used an 1099cc displacement engine, the Honda VT1100 engine with minimal mechanical changes during its production.


title: Honda Shadow

text: The VT1100C (Sc18?) model was introduced in 1985 as a larger model from the 750/800 cc models. The 1985–86 models are recognizable by the dual horns below the headlight, square turn signals, dual front disk brakes, and one exhaust pipe on each side (front cylinder on right side, rear cylinder on left). There are dual gauges on the bars for speedometer and tachometer, and fuel and temperature gauges that on the fuel tank. The engine is a SOHC liquid cooled V-twin with a five-speed transmission and shaft drive. the 1985 and 1986 engines were higher performance engines vs later models, having a longer stroke and smaller piston compared to 1987 and later models, allowing this first generation motor to make approximately 76 horsepower.


title: Honda Shadow

text: The 1987 VT1100C model took on a brand-new look with a lower seat (), a longer wheelbase , a fuel tank, an extended front fork , and weighs a hefty . Both exhaust pipes were now run along the right side of the bike, with the horns being relocated to the sides of the engine. The engine, while the same 1099 cc displacement as the previous model, is rated for approximately 63 horsepower due to shorter stroke and larger pistons. It also now had a four-speed transmission with a hydraulically actuated clutch. The "VT1100C" model was not manufactured in 1991 (to sell off excess stock of 1990 models), but returned in 1992 with a "Made in the USA" stamp on the seat.<br>


title: Honda Shadow

text: Some sites will list this model as the "VT1100 Standard" or "1100 Shadow Standard", but this was never an official name. <br>


title: Honda Shadow

text: In 1995, the V-Twin market really got going, and manufacturers expanded their offerings with variants of their standing models. <br>The American Classic Edition (A.C.E.) (VT1100C2) was introduced this year as an additional model to the still available VT1100C. It featured a more retro styling than the VT1100C, with a full rear fender, induced vibrations, and a 'Harley-Davidson-like' sound from a single pin crank engine. The model lost about 10 hp, but gained a new 5 speed transmission.


title: Honda Shadow

text: 1997 saw the Standard replaced with the Spirit with more chrome on the engine but the same basic engine as the standard. This model also has a 5 speed transmission and a cable actuated clutch. There were slight frame and body work changes with this model versus the previous model as well. Horns were moved to the front of the bike and the front exhaust now follows the frame instead of cutting across the engine.<br> An ACE Tourer was also introduced based on the 1100 Spirit engine but the ACE styling. The ACE Tourer came with a two-into-one-into-two exhaust system, a counterbalanced with a dual crank pin crankshaft, and hard, color-matched saddlebags. The last of the 6,000+ Tourer models was produced in January 2001.


title: Honda Shadow

text: In 1998, 1100cc Honda rolled out the VT1100C3 Aero, based on the VT1100C2 ACE engine with the single pin crank, but a larger two into one exhaust and more retro styling. The 1100 Aero was discontinued after the 2003 model year.


title: Honda Shadow

text: The Honda Shadow Sabre model was introduced, based on the Honda VT1100 engine with different styling than the still manufactured Spirit model. The most notable feature was the front cast aluminum wheel. This model also had a slightly lower rear gear ratio in the transmission allowing the bike to have better off the line acceleration than the regular Spirit model; however this also caused higher engine RPM at highway speeds. <br>


title: Honda Shadow

text: Due to lower sales and the availability of the VTX1300, 2007 was the final year Honda made the VT1100 Shadow.


title: Rage of Bahamut (TV series)

text: The first season, titled , consists of 12 episodes aired between October 6, 2014 and December 29, 2014. It has been licensed for streaming in North America by Funimation. A second season, titled , was announced on May 6, 2015 at the series' orchestra concert event. It consists of 24 episodes aired between April 7, 2017 and September 29, 2017. Amazon exclusively streamed the second season in the United States and in the United Kingdom on their Prime Video service. The streaming in the United States was originally part of the now defunct Anime Strike service.


title: Rage of Bahamut (TV series)

text: A spin-off series, titled "Manaria Friends", was released in 2019. It is also based on the "Rage of Bahamut" social game.


title: Rage of Bahamut (TV series)

text: Mistarcia is a magical world where humans, gods, and demons mingle together. In the past, the black-and-silver winged demon beast Bahamut had threatened to destroy the land, but humans, gods, and demons overcame their differences to fight together and sealed its power. The key to that seal was split in two, one half given to the gods and the other to demons, so that they would never be united and Bahamut never released. Now, two thousand years later, the world is in an era of peace until the day a woman named Amira appears with the gods' half of the key. With an apparent loss of memory, she searches for her lost mother and is assisted by the bounty hunters Favaro Leone and Kaisar Lidfard. Their quest is part of a larger story of an epic clash between humans, gods and demons, between those who want to revive Bahamut and those who are trying to prevent it.


title: Rage of Bahamut (TV series)

text: The anime is directed by Keiichi Sato, with series composition by Keiichi Hasegawa, character designs by Naoyuki Onda and music by Yoshihiro Ike.


title: Drinking Buddies

text: Drinking Buddies is a 2013 American comedy-drama film written, directed and edited by Joe Swanberg, and starring Olivia Wilde, Jake Johnson, Anna Kendrick and Ron Livingston. The film is about two co-workers at a craft brewery in Chicago.


title: Drinking Buddies

text: The film premiered at the 2013 South by Southwest Film Festival, and also screened within Maryland Film Festival 2013.


title: Drinking Buddies

text: Kate and Luke are co-workers at Chicago craft brewery Revolution Brewing, spending their days drinking and goofing off. Seemingly perfect for each other, they are both in relationships with other people. Kate is with Chris, and Luke with Jill. Jill is a nice, practical girl, and Chris an introvert. Jill wants to get married, which Luke promises to talk about soon.


title: Drinking Buddies

text: One day, Luke and Kate are drinking with co-workers, and Jill and Chris also show up. Chris invites the other couple to join him and Kate on a trip to his cottage. On a hike on the trip, Jill and Chris kiss.


title: Drinking Buddies

text: Luke and Kate spend the whole trip drinking and staying up late together, and have a bonfire. Kate dares Luke to go skinny dipping, stripping and running into the lake.


title: Drinking Buddies

text: When the couples return home, Chris realizes his and Kate's differences and breaks up with her. Kate insists the whole brewery crew go out the next evening for drinks to celebrate her 'singleness'. That night she ends up sleeping with co-worker, Dave. When Luke hears, he is angry at them both, spending the whole day snapping at them, but later apologizes.


title: Drinking Buddies

text: Jill decides to go away for a week with some college friends. During this trip, Luke and Kate go out for dinner and fall asleep together on the couch. He helps her pack up her old apartment and move the next day. At the end of the day, he falls asleep on the bed. Kate joins him.


title: Drinking Buddies

text: The next morning, Luke and Kate keep moving, planning to have a celebratory dinner when they are done. He cuts his hand badly while helping move a couch, and she is squeamish about the blood and unhelpful. An impatient driver, blocked by the moving van, starts a fight with Luke. Kate calls Dave and another co-worker to help finish the move. Dave invites Kate out for drinks, and she agrees instead of dining with Luke. He is annoyed and they argue.


title: Drinking Buddies

text: Returning home, Luke finds Jill has come home early, and she is crying. She sees his injuries and while cleaning him up, confesses to kissing Chris while at the cottage. She tells him how guilty she feels about it, and that she really loves him and wants to marry him. Luke forgives Jill and lets her know that he still loves her and wants to marry her too. The next day at work Kate and Luke awkwardly interact and then eventually sit together at lunch. They offer one another bits of their lunch, Kate refusing the banana and he tosses it, their way of saying they will remain friends. They smile and share a beer.


title: Drinking Buddies

text: The idea to set the film in a brewery came when director Joe Swanberg received a brewing set-up as a birthday present. According to Swanberg,


title: Drinking Buddies

text: I wanted to do something about Craft Beer [independent breweries] and set in the Craft Beer world but also I was inspired by "Bob & Carol & Ted & Alice", a Paul Mazursky movie. Just to tell a complicated adult [story] that was funny, that managed to remain funny even though it was getting into serious, interesting things.


title: Drinking Buddies

text: The dialogue was improvised. Instead of a script, the actors received outlines which covered the major plot points and were told each day what had to happen in that day's scenes. Relying heavily on improvisation is a key feature of the Mumblecore film movement. He said, "knowing that the structure was already pretty heavily in place, it was about letting the actors own their characters, and have a big say in the clothes that they wore, and in the interactions that they have with each other." He added: "The improv was used to mainly make the middle of the movie more complicated, and less predictable than a typical romantic comedy would be." Swanberg also stated "They need to be listening to each other and reacting honestly and I need to be paying really close attention because there’s not a script to fall back on. The goal of doing it that way is to keep everybody engaged and create situations that feel fun and natural".


title: Drinking Buddies

text: Filming took place in Chicago, Illinois in July 2012. The film was shot in an actual brewery, called Revolution, where one of the female brewers named Kate was the basis for Wilde's character. The actors actually drank real beer during the filming and even did real work for the brewing company. Wilde would later comment that the cast was "hammered the entire movie."


title: Drinking Buddies

text: The film concludes with an open ending with Swanberg stating "it's hard for me, knowing how uncertain the world is, to put a certain, definite ending on a movie. I feel like I'm hopefully hinting that there's a resolution without it being cemented down, or hammering you over the head with it."


title: Drinking Buddies

text: "Drinking Buddies" has music supervised by Chris Swanson, Grant Manship and Kathleen Cook of Jagjaguwar. The soundtrack features Jag artists Foxygen and Richard Youngs, The Amazing and Richard Swift, as well as Plants & Animals, Here We Go Magic, Phèdre, and other additional artists.


title: Drinking Buddies

text: Olivia Wilde said getting nude for this movie was all her idea. There was no script for the film, only Swanberg as its captain, and Wilde told her director she wanted to skinny dip because "it felt so incredibly organic to that moment."


title: Drinking Buddies

text: "Drinking Buddies" received positive reviews from critics. , the film holds an 84% approval rating on the review aggregation website Rotten Tomatoes, based on 122 reviews with an average rating of 6.9/10. The site's consensus reads, "Smart, funny, and powered by fine performances from Olivia Wilde and Jake Johnson, "Drinking Buddies" offers a bittersweet slice of observational comedy." On Metacritic the film has a weighted average score of 71 out of 100, based on 32 critics, indicating "general favorable reviews".


title: Drinking Buddies

text: A. O. Scott of "The New York Times" remarked "Mr. Swanberg’s camera weaves through bodies at rest, at work and at the bar in no particular hurry, and his script captures the idioms of men and women who are equally inclined to waste words and to say very little. But the busy tedium of their lives is given shape and direction by the skill of the cast and by the precision of the director’s eye, ear and editing instincts."


title: Drinking Buddies

text: Upon the film's UK release, Peter Bradshaw gave the film three stars out of five, calling it "a lo-fi relationship drama that is interesting, if unevenly presented...an intriguing and distinctive story, soberly told"; according to Bradshaw, "Swanberg interestingly shows how booze loosens them up, lowers their inhibitions, and yet blurs their emotional reactions, in the process weirdly muting and endlessly deferring the sexual drama."


title: Medical device

text: A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.


title: Medical device

text: Discovery of what would be considered a medical device by modern standards dates as far back as c. 7000 BC in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it wasn't until the Federal Food, Drug, and Cosmetic Act (FD&C Act) in 1938 that medical devices were regulated. Later in 1976, the Medical Device Amendments to the FD&C Act established medical device regulation and oversight as we know it today in the United States. Medical device regulation in Europe as we know it today came into effect in the 1993 by what is collectively known as the Medical Device Directive (MDD). On May 26, 2017, the Medical Device Regulation (MDR) replaced the MDD.


title: Medical device

text: Medical devices vary in both their intended use and indications for use. Examples range from simple, low-risk devices such as tongue depressors, medical thermometers, disposable gloves, and bedpans to complex, high-risk devices that are implanted and sustain life. One example of high-risk devices are those with embedded software such as pacemakers, and which assist in the conduct of medical testing, implants, and prostheses. The design of medical devices constitutes a major segment of the field of biomedical engineering.


title: Medical device

text: The global medical device market reached roughly US$209 billion in 2006 and was estimated to be between $220 and US$250 billion in 2013. The United States controls ~40% of the global market followed by Europe (25%), Japan (15%), and the rest of the world (20%). Although collectively Europe has a larger share, Japan has the second largest country market share. The largest market shares in Europe (in order of market share size) belong to Germany, Italy, France, and the United Kingdom. The rest of the world comprises regions like (in no particular order) Australia, Canada, China, India, and Iran. This article discusses what constitutes a medical device in these different regions and throughout the article these regions will be discussed in order of their global market share.


title: Medical device

text: A global definition for medical device is difficult to establish because there are numerous regulatory bodies worldwide overseeing the marketing of medical devices. Although these bodies often collaborate and discuss the definition in general, there are subtle differences in wording that prevent a global harmonization of the definition of a medical device, thus the appropriate definition of a medical device depends on the region. Often a portion of the definition of a medical device is intended to differentiate between medical devices and drugs, as the regulatory requirements of the two are different. Definitions also often recognize In vitro diagnostics as a subclass of medical devices and establish accessories as medical devices.


title: Medical device

text: Section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act defines a device as an "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:


title: Medical device

text: which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term 'device' does not include software functions excluded pursuant to section 520(o)."


title: Medical device

text: According to Article 1 of Council Directive 93/42/EEC, 'medical device' means any "instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:


title: Medical device

text: and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;"


title: Medical device

text: Based on the "New Approach", rules that relate to safety and performance of medical devices were harmonised in the EU in the 1990s. The "New Approach", defined in a European Council Resolution of May 1985, represents an innovative way of technical harmonisation. It aims to remove technical barriers to trade and dispel the consequent uncertainty for economic operators, to facilitate free movement of goods inside the EU.


title: Medical device

text: They aim at ensuring a high level of protection of human health and safety and the good functioning of the Single Market. These three main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47 EC.


title: Medical device

text: The government of each Member State must appoint a "competent authority" responsible for medical devices. The competent authority (CA) is a body with authority to act on behalf of the member state to ensure that member state government transposes requirements of medical device directives into national law and applies them. The CA reports to the minister of health in the member state. The CA in one Member State has no jurisdiction in any other member state, but exchanges information and tries to reach common positions.


title: Medical device

text: In the UK, for example, the Medicines and Healthcare products Regulatory Agency (MHRA) acted as a CA. In Italy it is the Ministero Salute (Ministry of Health) Medical devices must not be mistaken with medicinal products. In the EU, all medical devices must be identified with the CE mark. The conformity of a medium or high risk medical device with relevant regulations is also assessed by an external entity, the Notified Body, before it can be placed on the market.


title: Medical device

text: In September 2012, the European Commission proposed new legislation aimed at enhancing safety, traceability, and transparency. The regulation was adopted in 2017.


title: Medical device

text: The future core legal framework consists of two regulations, replacing the previous three directives:


title: Medical device

text: Article 2, Paragraph 4, of the Pharmaceutical Affairs Law (PAL) defines medical devices as "instruments and apparatus intended for use in diagnosis, cure or prevention of diseases in humans or other animals; intended to affect the structure or functions of the body of man or other animals."


title: Medical device

text: The term medical device, as defined in the Food and Drugs Act, is "any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in: the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in a human being; the restoration, correction or modification of a body function or the body structure of a human being; the diagnosis of pregnancy in a human being; or the care of a human being during pregnancy and at and after the birth of a child, including the care of the child. It also includes a contraceptive device but does not include a drug."


title: Medical device

text: The term covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. Health Canada reviews medical devices to assess their safety, effectiveness, and quality before authorizing their sale in Canada. According to the Act, medical device does not include any device that is intended for use in relation to animals."


title: Medical device

text: There is no specific definition of the term 'medical devices' in Indian law. However, certain medical devices are notified as DRUGS under the Drugs & Cosmetics Act. Section 3 (b) (iv) relating to definition of "drugs" holds that "Devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals" are also drugs. As of April 2022, 14 classes of devices are classified as drugs.


title: Medical device

text: The regulatory authorities recognize different classes of medical devices based on their potential for harm if misused, design complexity, and their use characteristics. Each country or region defines these categories in different ways. The authorities also recognize that some devices are provided in combination with drugs, and regulation of these combination products takes this factor into consideration.


title: Medical device

text: Classifying medical devices based on their risk is essential for maintaining patient and staff safety while simultaneously facilitating the marketing of medical products. By establishing different risk classifications, lower risk devices, for example, a stethoscope or tongue depressor, are not required to undergo the same level of testing that higher risk devices such as artificial pacemakers undergo. Establishing a hierarchy of risk classification allows regulatory bodies to provide flexibility when reviewing medical devices.


title: Medical device

text: Under the Food, Drug, and Cosmetic Act, the U.S. Food and Drug Administration recognizes three classes of medical devices, based on the level of control necessary to assure safety and effectiveness.


title: Medical device

text: The classification procedures are described in the Code of Federal Regulations, Title 21, part 860 (usually known as 21 CFR 860).


title: Medical device

text: Class I devices are subject to the least regulatory control and are not intended to help support or sustain life or be substantially important in preventing impairment to human health, and may not present an unreasonable risk of illness or injury. Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments.


title: Medical device

text: Class II devices are subject to special labeling requirements, mandatory performance standards and postmarket surveillance. Examples of Class II devices include acupuncture needles, powered wheelchairs, infusion pumps, air purifiers, surgical drapes, stereotaxic navigation systems, and surgical robots.


title: Medical device

text: Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury and require premarket approval. Examples of Class III devices include implantable pacemakers, pulse generators, HIV diagnostic tests, automated external defibrillators, and endosseous implants.


title: Medical device

text: The classification of medical devices in the European Union is outlined in Article IX of the Council Directive 93/42/EEC and Annex VIII of the EU medical device regulation. There are basically four classes, ranging from low risk to high risk, Classes I, IIa, IIb, and III (this excludes "in vitro" diagnostics including software, which fall in four classes: from A (lowest risk) to D (highest risk)):


title: Medical device

text: Class I Devices: Non-invasive, everyday devices or equipment. Class I devices are generally low risk and can include bandages, compression hosiery, or walking aids. Such devices require only for the manufacturer to complete a Technical File.


title: Medical device

text: Class Is Devices: Class Is devices are similarly non-invasive devices, however this sub-group extends to include sterile devices. Examples of Class Is devices include stethoscopes, examination gloves, colostomy bags, or oxygen masks. These devices also require a technical file, with the added requirement of an application to a European Notified Body for certification of manufacturing in conjunction with sterility standards.


title: Medical device

text: Class Im Devices: This refers chiefly to similarly low-risk measuring devices. Included in this category are: thermometers, droppers, and non-invasive blood pressure measuring devices. Once again the manufacturer must provide a technical file and be certified by a European Notified Body for manufacturing in accordance with metrology regulations.


title: Medical device

text: Class IIa Devices: Class IIa devices generally constitute low to medium risk and pertain mainly to devices installed within the body in the short term. Class IIa devices are those which are installed within the body for only between 60 minutes and 30 days. Examples include hearing-aids, blood transfusion tubes, and catheters. Requirements include technical files and a conformity test carried out by a European Notified Body.


title: Medical device

text: Class IIb Devices: Slightly more complex than IIa devices, class IIb devices are generally medium to high risk and will often be devices installed within the body for periods of 30 days or longer. Examples include ventilators and intensive care monitoring equipment. Identical compliance route to Class IIa devices with an added requirement of a device type examination by a Notified Body.


title: Medical device

text: Class III Devices: Class III devices are strictly high risk devices. Examples include balloon catheters, prosthetic heart valves, pacemakers, etc. The steps to approval here include a full quality assurance system audit, along with examination of both the device's design and the device itself by a European Notified Body.


title: Medical device

text: The authorization of medical devices is guaranteed by a Declaration of Conformity. This declaration is issued by the manufacturer itself, but for products in Class Is, Im, Ir, IIa, IIb or III, it must be verified by a Certificate of Conformity issued by a Notified Body. A Notified Body is a public or private organisation that has been accredited to validate the compliance of the device to the European Directive. Medical devices that pertain to class I (on condition they do not require sterilization or do not measure a function) can be marketed purely by self-certification.


title: Medical device

text: The European classification depends on rules that involve the medical device's duration of body contact, invasive character, use of an energy source, effect on the central circulation or nervous system, diagnostic impact, or incorporation of a medicinal product. Certified medical devices should have the CE mark on the packaging, insert leaflets, etc.. These packagings should also show harmonised pictograms and EN standardised logos to indicate essential features such as instructions for use, expiry date, manufacturer, sterile, don't reuse, etc.


title: Medical device

text: In November 2018 the Federal Administrative Court of Switzerland decided that the "Sympto" app, used to analyze a woman's menstrual cycle, was a medical device because it calculates a fertility window for each woman using personal data. The manufacturer, Sympto-Therm Foundation, argued that this was a didactic, not a medical process. the court laid down that an app is a medical device if it is to be used for any of the medical purposes provided by law, and creates or modifies health information by calculations or comparison, providing information about an individual patient.


title: Medical device

text: Medical devices (excluding in vitro diagnostics) in Japan are classified into four classes based on risk:


title: Medical device

text: Classes I and II distinguish between extremely low and low risk devices. Classes III and IV, moderate and high risk respectively, are highly and specially controlled medical devices. In vitro diagnostics have three risk classifications.


title: Medical device

text: For the remaining regions in the world the risk classifications are generally similar to the United States, European Union, and Japan or are a variant combining two or more of the three countries' risk classifications.


title: Medical device

text: The classification of medical devices in Australia is outlined in section 41BD of the Therapeutic Goods Act 1989 and Regulation 3.2 of the Therapeutic Goods Regulations 2002, under control of the Therapeutic Goods Administration. Similarly to the EU classification, they rank in several categories, by order of increasing risk and associated required level of control. Various rules identify the device's category


title: Medical device

text: The Medical Devices Bureau of Health Canada recognizes four classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device. Class I devices present the lowest potential risk and do not require a licence. Class II devices require the manufacturer's declaration of device safety and effectiveness, whereas Class III and IV devices present a greater potential risk and are subject to in-depth scrutiny. A guidance document for device classification is published by Health Canada.


title: Medical device

text: Canadian classes of medical devices correspond to the European Council Directive 93/42/EEC (MDD) devices:


title: Medical device

text: Examples include surgical instruments (Class I), contact lenses and ultrasound scanners (Class II), orthopedic implants and hemodialysis machines (Class III), and cardiac pacemakers (Class IV).


title: Medical device

text: Medical devices in India are regulated by Central Drugs Standard Control Organisation (CDSCO). Medical devices under the Medical Devices Rules, 2017 are classified as per Global Harmonization Task Force (GHTF) based on associated risks.


title: Medical device

text: Iran produces about 2,000 types of medical devices and medical supplies, such as appliances, dental supplies, disposable sterile medical items, laboratory machines, various biomaterials and dental implants. 400 Medical products are produced at the C and D risk class with all of them licensed by the Iranian Health Ministry in terms of safety and performance based on EU-standards.


title: Medical device

text: Some producers in Iran export medical devices and supplies which adhere to European Union standards to applicant countries, including 40 Asian and European countries.


title: Medical device

text: The ISO standards for medical devices are covered by ICS 11.100.20 and 11.040.01. The quality and risk management regarding the topic for regulatory purposes is convened by ISO 13485 and ISO 14971. ISO 13485:2016 is applicable to all providers and manufacturers of medical devices, components, contract services and distributors of medical devices. The standard is the basis for regulatory compliance in local markets, and most export markets. Additionally, sets precedence because it signifies that a company engages in the creation of new products. It requires that the development of manufactured products have an approval process and a set of rigorous quality standards and development records before the product is distributed. Further standards are IEC 60601-1 which is for electrical devices (mains-powered as well as battery powered), EN 45502-1 which is for Active implantable medical devices, and IEC 62304 for medical software. The US FDA also published a series of guidances for industry regarding this topic against 21 CFR 820 Subchapter H—Medical Devices. Subpart B includes quality system requirements, an important component of which are design controls (21 CFR 820.30). To meet the demands of these industry regulation standards, a growing number of medical device distributors are putting the complaint management process at the forefront of their quality management practices. This approach further mitigates risks and increases visibility of quality issues.


title: Medical device

text: Starting in the late 1980s the FDA increased its involvement in reviewing the development of medical device software. The precipitant for change was a radiation therapy device (Therac-25) that overdosed patients because of software coding errors. FDA is now focused on regulatory oversight on medical device software development process and system-level testing.


title: Medical device

text: A 2011 study by Dr. Diana Zuckerman and Paul Brown of the National Center for Health Research, and Dr. Steven Nissen of the Cleveland Clinic, published in the "Archives of Internal Medicine", showed that most medical devices recalled in the last five years for "serious health problems or death" had been previously approved by the FDA using the less stringent, and cheaper, 510(k) process. In a few cases, the devices had been deemed so low-risk that they did not they did not undergo any FDA regulatory review. Of the 113 devices recalled, 35 were for cardiovascular issues. This study was the topic of Congressional hearings re-evaluating FDA procedures and oversight.


title: Medical device

text: A 2014 study by Dr. Diana Zuckerman, Paul Brown, and Dr. Aditi Das of the National Center for Health Research, published in JAMA Internal Medicine, examined the scientific evidence that is publicly available about medical implants that were cleared by the FDA 510(k) process from 2008 to 2012. They found that scientific evidence supporting "substantial equivalence" to other devices already on the market was required by law to be publicly available, but the information was available for only 16% of the randomly selected implants, and only 10% provided clinical data. Of the more than 1,100 predicate implants that the new implants were substantially equivalent to, only 3% had any publicly available scientific evidence, and only 1% had clinical evidence of safety or effectiveness. The researchers concluded that publicly available scientific evidence on implants was needed to protect the public health.


title: Medical device

text: In 2014-2015 a new international agreement, the Medical Device Single Audit Program (MDSAP), was put in place with five participant countries: Australia, Brazil, Canada, Japan, and the United States. The aim of this program was to "develop a process that allows a single audit, or inspection to ensure the medical device regulatory requirements for all five countries are satisfied".


title: Medical device

text: In 2017, a study by Dr. Jay Ronquillo and Dr. Diana Zuckerman published in the peer-reviewed policy journal Milbank Quarterly found that electronic health records and other device software were recalled due to life-threatening flaws. The article pointed out the lack of safeguards against hacking and other cybersecurity threats, stating "current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market". They added that legislative changes resulting from the law entitled the 21st Century Cures Act "will further deregulate health IT, reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients".


title: Medical device

text: A study by Dr. Stephanie Fox-Rawlings and colleagues at the National Center for Health Research, published in 2018 in the policy journal Milbank Quarterly, investigated whether studies reviewed by the FDA for high-risk medical devices are proven safe and effective for women, minorities, or patients over 65 years of age. The law encourages patient diversity in clinical trials submitted to the FDA for review, but does not require it. The study determined that most high-risk medical devices are not tested and analyzed to ensure that they are safe and effective for all major demographic groups, particularly racial and ethnic minorities and people over 65. Therefore, they do not provide information about safety or effectiveness that would help patients and physicians make well informed decisions.


title: Medical device

text: In 2018, an investigation involving journalists across 36 countries coordinated by the International Consortium of Investigative Journalists (ICIJ) prompted calls for reform in the United States, particularly around the 510(k) substantial equivalence process; the investigation prompted similar calls in the UK and Europe Union.


title: Medical device

text: Medical device packaging is highly regulated. Often medical devices and products are sterilized in the package.


title: Medical device

text: Sterility must be maintained throughout distribution to allow immediate use by physicians. A series of special packaging tests measure the ability of the package to maintain sterility. Relevant standards include:


title: Medical device

text: Package testing is part of a quality management system including verification and validation. It is important to document and ensure that packages meet regulations and end-use requirements. Manufacturing processes must be controlled and validated to ensure consistent performance. EN ISO 15223-1 defines symbols that can be used to convey important information on packaging and labeling.


title: Medical device

text: Medical device cleanliness has come under greater scrutiny since 2000, when Sulzer Orthopedics recalled several thousand metal hip implants that contained a manufacturing residue. Based on this event, ASTM established a new task group (F04.15.17) for established test methods, guidance documents, and other standards to address cleanliness of medical devices. This task group has issued two standards for permanent implants to date: 1. ASTM F2459: Standard test method for extracting residue from metallic medical components and quantifying via gravimetric analysis 2. ASTM F2847: Standard Practice for Reporting and Assessment of Residues on Single Use Implants 3. ASTM F3172: Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices


title: Medical device

text: The ASTM F04.15.17 task group is working on several new standards that involve designing implants for cleaning, selection and testing of brushes for cleaning reusable devices, and cleaning assessment of medical devices made by additive manufacturing. Additionally, the FDA is establishing new guidelines for reprocessing reusable medical devices, such as orthoscopic shavers, endoscopes, and suction tubes. New research was published in ACS Applied Interfaces and Material to keep Medical Tools pathogen free.


title: Medical device

text: Medical device manufacturing requires a level of process control according to the classification of the device. Higher risk; more controls. When in the initial R&D phase, manufacturers are now beginning to design for manufacturability. This means products can be more precision-engineered to for production to result in shorter lead times, tighter tolerances and more advanced specifications and prototypes. These days, with the aid of CAD or modelling platforms, the work is now much faster, and this can act also as a tool for strategic design generation as well as a marketing tool.


title: Medical device

text: Failure to meet cost targets will lead to substantial losses for an organisation. In addition, with global competition, the R&D of new devices is not just a necessity, it is an imperative for medical device manufacturers. The realisation of a new design can be very costly, especially with the shorter product life cycle. As technology advances, there is typically a level of quality, safety and reliability that increases exponentially with time.


title: Medical device

text: For example, initial models of the artificial cardiac pacemaker were external support devices that transmits pulses of electricity to the heart muscles via electrode leads on the chest. The electrodes contact the heart directly through the chest, allowing stimulation pulses to pass through the body. Recipients of this typically developed an infection at the entrance of the electrodes, which led to the subsequent trial of the first internal pacemaker, with electrodes attached to the myocardium by thoracotomy. Future developments led to the isotope-power source that would last for the lifespan of the patient.


title: Medical device

text: With the rise of smartphone usage in the medical space, in 2013, the FDA issued to regulate mobile medical applications and protect users from their unintended use, soon followed by European and other regulatory agencies. This guidance distinguishes the apps subjected to regulation based on the marketing claims of the apps. Incorporation of the guidelines during the development phase of such apps can be considered as developing a medical device; the regulations have to adapt and propositions for expedite approval may be required due to the nature of 'versions' of mobile application development.


title: Medical device

text: On September 25, 2013, the FDA released a draft guidance document for regulation of mobile medical applications, to clarify what kind of mobile apps related to health would not be regulated, and which would be.


title: Medical device

text: Medical devices such as pacemakers, insulin pumps, operating room monitors, defibrillators, and surgical instruments, including deep-brain stimulators, can incorporate the ability to transmit vital health information from a patient's body to medical professionals. Some of these devices can be remotely controlled. This has engendered concern about privacy and security issues, human error, and technical glitches with this technology. While only a few studies have looked at the susceptibility of medical devices to hacking, there is a risk. In 2008, computer scientists proved that pacemakers and defibrillators can be hacked wirelessly via radio hardware, an antenna, and a personal computer. These researchers showed they could shut down a combination heart defibrillator and pacemaker and reprogram it to deliver potentially lethal shocks or run out its battery. Jay Radcliff, a security researcher interested in the security of medical devices, raised fears about the safety of these devices. He shared his concerns at the Black Hat security conference. Radcliff fears that the devices are vulnerable and has found that a lethal attack is possible against those with insulin pumps and glucose monitors. Some medical device makers downplay the threat from such attacks and argue that the demonstrated attacks have been performed by skilled security researchers and are unlikely to occur in the real world. At the same time, other makers have asked software security experts to investigate the safety of their devices. As recently as June 2011, security experts showed that by using readily available hardware and a user manual, a scientist could both tap into the information on the system of a wireless insulin pump in combination with a glucose monitor. With the PIN of the device, the scientist could wirelessly control the dosage of the insulin. Anand Raghunathan, a researcher in this study, explains that medical devices are getting smaller and lighter so that they can be easily worn. The downside is that additional security features would put an extra strain on the battery and size and drive up prices. Dr. William Maisel offered some thoughts on the motivation to engage in this activity. Motivation to do this hacking might include acquisition of private information for financial gain or competitive advantage; damage to a device manufacturer's reputation; sabotage; intent to inflict financial or personal injury or just satisfaction for the attacker. Researchers suggest a few safeguards. One would be to use rolling codes. Another solution is to use a technology called "body-coupled communication" that uses the human skin as a wave guide for wireless communication. On 28 December 2016 the US Food and Drug Administration released its recommendations that are not legally enforceable for how medical device manufacturers should maintain the security of Internet-connected devices.


title: Medical device

text: Similar to hazards, cybersecurity threats and vulnerabilities cannot be eliminated but must be managed and reduced to a reasonable level. When designing medical devices, the tier of cybersecurity risk should be determined early in the process in order to establish a cybersecurity vulnerability and management approach (including a set of cybersecurity design controls). The medical device design approach employed should be consistent with the NIST Cybersecurity Framework for managing cybersecurity-related risks.


title: Medical device

text: In August 2013, the FDA released over 20 regulations aiming to improve the security of data in medical devices, in response to the growing risks of limited cybersecurity.


title: Medical device

text: The number of approved medical devices using artificial intelligence or machine learning (AI/ML) is increasing. As of 2020, there were several hundred AI/ML medical devices approved by the US FDA or CE-marked devices in Europe. Most AI/ML devices focus upon radiology. As of 2020, there was no specific regulatory pathway for AI/ML-based medical devices in the US or Europe. However, in January 2021, the FDA published a proposed regulatory framework for AI/ML-based software, and the EU medical device regulation which replaces the EU Medical Device Directive in May 2021, defines regulatory requirements for medical devices, including AI/ML software.


title: Medical device

text: Medical equipment (also known as armamentarium) is designed to aid in the diagnosis, monitoring or treatment of medical conditions.


title: Medical device

text: The identification of medical devices has been recently improved by the introduction of Unique Device Identification (UDI) and standardised naming using the Global Medical Device Nomenclature (GMDN) which have been endorsed by the International Medical Device Regulatory Forum (IMDRF).


title: Medical device

text: A biomedical equipment technician (BMET) is a vital component of the healthcare delivery system. Employed primarily by hospitals, BMETs are the people responsible for maintaining a facility's medical equipment. BMET mainly act as an interface between doctor and equipment.


title: Medical device

text: There are challenges surrounding the availability of medical equipment from a global health perspective, with low-resource countries unable to obtain or afford essential and life-saving equipment. In these settings, well-intentioned equipment donation from high- to low-resource settings is a frequently used strategy to address this through individuals, organisations, manufacturers and charities. However, issues with maintenance, availability of biomedical equipment technicians (BMET), supply chains, user education and the appropriateness of donations means these frequently fail to deliver the intended benefits. The WHO estimates that 95% of medical equipment in low- and middle-income countries (LMICs) is imported and 80% of it is funded by international donors or foreign governments. While up to 70% of medical equipment in sub-Saharan Africa is donated, only 10%–30% of donated equipment becomes operational. A review of current practice and guidelines for the donation of medical equipment for surgical and anaesthesia care in LMICs has demonstrated a high level of complexity within the donation process and numerous shortcomings. Greater collaboration and planning between donors and recipients is required together with evaluation of donation programs and concerted advocacy to educate donors and recipients on existing equipment donation guidelines and policies


title: Treta Yuga

text: Treta Yuga, in Hinduism, is the second and second best of the four "yugas" (world ages) in a "Yuga Cycle", preceded by "Krita (Satya) Yuga" and followed by "Dvapara Yuga". "Treta Yuga" lasts for 1,296,000 years (3,600 divine years).


title: Treta Yuga

text: "Treta" means 'a collection of three things' in Sanskrit, and is so called because during the "Treta Yuga", there were three Avatars of Vishnu that were seen, the fifth, sixth and seventh incarnations as Vamana, Parashurama and Rama, respectively. The bull of Dharma symbolizes that morality stood on three legs during this period. It had all four legs in the "Satya Yuga" and two in the succeeding "Dvapara Yuga". Currently, in the immoral age of "Kali", it stands on one leg.


title: Treta Yuga

text: Yuga (), in this context, means "an age of the world", where its archaic spelling is yug, with other forms of yugam, ', and yuge, derived from yuj (), believed derived from ""' (Proto-Indo-European: 'to join or unite').


title: Treta Yuga

text: Treta Yuga () means "the age of three or triads", where its length is three times that of "Kali Yuga", and the "Dharma" bull, which symbolizes morality, stands on three legs during this period.


title: Treta Yuga

text: "Treta Yuga" is described in the "Mahabharata", "Manusmriti", "Surya Siddhanta", "Vishnu Smriti", and various Puranas.


title: Treta Yuga

text: Hindu texts describe four "yugas" (world ages) in a "Yuga Cycle", where, starting in order from the first age of "Krita (Satya) Yuga", each "yuga's" length decreases by one-fourth (25%), giving proportions of 4:3:2:1. Each "yuga" is described as having a main period ( "yuga" proper) preceded by its (dawn) and followed by its (dusk), where each twilight (dawn/dusk) lasts for one-tenth (10%) of its main period. Lengths are given in divine years (years of the gods), each lasting for 360 solar (human) years.


title: Treta Yuga

text: "Treta Yuga", the second age in a cycle, lasts for 1,296,000 years (3,600 divine years), where its main period lasts for 1,080,000 years (3,000 divine years) and its two twilights each lasts for 108,000 years (300 divine years). The current cycle's "Treta Yuga" has the following dates based on "Kali Yuga", the fourth and present age, starting in 3102BCE:


title: Josette Simon

text: Josette Patricia Simon is a British actress. She trained for the stage at the Central School of Speech and Drama in London, and played the part of Dayna Mellanby in the third and fourth series of the television sci-fi series "Blake's 7" from 1980 to 1981. On stage, she has appeared in Royal Shakespeare Company (RSC) productions from 1982, playing Ariel in "The Tempest", to 2018 when she was Cleopatra in "Antony and Cleopatra". The first black woman in an RSC play, Simon has been at the forefront of 'colour-blind casting', playing roles traditionally taken by white actresses, including Maggie, a character that is thought to be based on Marilyn Monroe, in Arthur Miller's "After the Fall" at the National Theatre in 1990.


title: Josette Simon

text: Her first leading role at the RSC, the first for a black actress, was as Rosaline, in Love's Labour's Lost, directed by Barry Kyle, in 1984. In 1987, Simon appeared for the RSC again, in the lead role of Isabelle in "Measure for Measure". Later leading roles for the RSC saw her as Titania/Hippolyta in "A Midsummer Night's Dream" (1999–2000) and Cleopatra in Antony And Cleopatra (2017–18). She has played numerous other roles across stage, television, film, and radio.


title: Josette Simon

text: Simon won the "Evening Standard" Best Actress award, a Critics' Circle Theatre Award, and "Plays and Players" Critic Awards for "After the Fall", and two film festival awards for her part in "Milk and Honey" (1988). She was awarded the Order of the British Empire in 2000, for services to drama.


title: Josette Simon

text: Josette Patricia Simon was born in Leicester. Her mother, from Anguilla, and her father, from Antigua had both moved to Leicester in the 1950s, and worked at Thorn EMI. Simon attended Rushey Mead primary school, followed by Alderman Newton's Girls School. She became interested in acting after successfully auditioning, aged 14, with a friend for the choir for "Joseph and the Amazing Technicolor Dreamcoat". Simon later appeared in pantomimes before finishing secondary school, and played Martha in a 1976 production of "The Miracle Worker" directed by Michael Bogdanov at the Leicester Haymarket Theatre. Alan Rickman, who was in the production of "Joseph and the Amazing Technicolor Dreamcoat", encouraged Simon to apply for the Central School of Speech and Drama in London, and she was accepted.


title: Josette Simon

text: Simon won the part of Dayna Mellanby in the BBC 1 television sci-fi series "Blake's 7" after being talent-spotted while still at the Central School of Speech and Drama. Simon played Mellanby in the third and fourth series, originally broadcast between January 1980 and December 1981. The character was an expert combatant and highly knowledgeable about weapons.


title: Josette Simon

text: Simon has performed frequently with the Royal Shakespeare Company and Royal National Theatre. After taking part in a reading of "Salvation Now" by Snoo Wilson in 1982, she was cast as one of the three "weird sisters" in "Macbeth" alongside Kathy Behean and Lesley Sharp later that year. In the same RSC season, she had roles in "Much Ado About Nothing", as a spirit in "The Tempest" and as Iras in "Antony And Cleopatra". She was with the RSC for two consecutive two-year season cycles, and in the second cycle her roles included Nerissa in "The Merchant Of Venice" and starring as Dorcas Ableman in "Golden Girls". In 1997 she told academic Alison Oddey that what she learnt from working with Michael Gambon and, particularly, Helen Mirren for "Antony And Cleopatra" had been an early influence on her career.


title: Josette Simon

text: Simon was the first black woman to appear in a Shakespeare play at the RSC. She has been at the forefront of 'colour-blind casting', playing roles traditionally taken by white actresses. From the mid-1980s to the late 1990s, a time when it was unusual for black women to feature as leads in leading Shakespeare plays, Simon played several major roles for the RSC. Her first leading role, and the first for a black actress at the RSC, was as Rosaline, in Love's Labour's Lost, directed by Barry Kyle, in 1984. Jami Rogers, in her book "British Black and Asian Shakespeareans" (2022) commented that in Kyle's production, where the women were dressed in Belle Époque-style silk dresses, Rosalie's clothing "immediately marked her as a woman of high status ...For the first time on a major British stage, an African-Caribbean woman portrayed an intelligent, witty and strong leading Shakespearean character." Rogers described the reviews of the production as "glowing". She noted that some reviewers and academics "treated Josette Simon's casting ... as a novelty", criticising the description of integrated casting as an "experiment" as "deeply problematic as it infers the practice is an aberration rather than what it was [by 1990], a common practice". Simon told Oddey that , despite being conscious of discussions about whether audiences would accept a black actress as Rosaline, "I also felt that you should be allowed to fail, because if you don't take risks you can't reach higher planes" and that she had focused on her performance rather than debates around her casting, saying that "If I had thought about those things beforehand, I would not have set foot on the stage".


title: Josette Simon

text: In 1987, Simon appeared for the RSC again, in the lead role of Isabelle in "Measure for Measure", directed by Nicholas Hynter. In a review of the Stratford production, Michael Coveney of the "Financial Times" felt that Simon "fails ... with the full range of the role. Like so many of this season's leading ladies, she is technically underpowered." Irving Wardle wrote in "The Times" that:


title: Josette Simon

text: The play transferred to the Theatre Royal, Newcastle, and then to the Barbican in 1988. "Financial Times" critic Martin Hoyle wrote of the Barbican production that Simon "has transformed her voice, both timbre and enunciation ... Incisive, vocally varied, though slightly lacking the full weight for the early emotional climaxes, she gives the best performance I have seen from her, dignified and touching." In "The Times" in 1991, Benedict Nightingale opined that by casting Simon as Isabella and Rosaline, and Hugh Quarshie in other plays, the RSC had been "launching two performers of huge potential".


title: Josette Simon

text: In 2014, the RSC's Head of Casting, Hannah Miller, explained that the RSC's policy was to select the best actor for the role regardless of factors including gender, race, class, and disability status. Academic Lynette Goddard argued that despite the RSC's inclusive policy, black actresses still had limited opportunities to progress, "which makes Josette Simon's case all the more compelling". Goddard commented that "the more well known Simon became, the less compelled reviewers felt to mention race". Simon told David Jays of "The Guardian" in 2017 that "I hate the term 'black actor' ... I'm black, which I'm proud of, but it doesn't mean anything. You're an actor, full stop." Colour-blind casting also applied when Simon played Maggie in Arthur Miller's "After the Fall" at the National Theatre in 1990. The character is thought to have been based on Marilyn Monroe, who was married to Miller. It was a performance that won Simon the "Evening Standard"'s Best Actress award, Critics' Circle Theatre Award and "Plays and Players" Critic Awards. Miller attended rehearsals for two weeks, and Simon told Oddey that, like playing Rosaline, meeting Miller was one of the key moments in her career, and the experience helped her to focus on her work and disregard distractions. Simon portrayed Vittoria in the Royal National Theatre's "The White Devil" in 1991.


title: Josette Simon

text: Simon returned to the RSC in 1999 as Queen Elizabeth in "Don Carlos". Nightingale described her performance as " vivid and vital". Next, she was Titania/Hippolyta in "A Midsummer Night's Dream". The "Financial Times" reviewer wrote that Simon spoke "Titania's lines with an almost jazz musicality, dances, moves, and stands with compelling power. Her stance alone is more regal than that of several of today's ballerinas." Paul Taylor of "The Independent" called the production's Nicolas Jones and Simon " the sexiest, most commanding Oberon and Titania of recent years".


title: Josette Simon

text: In 2017, Simon took the role of Cleopatra in "Antony and Cleopatra" for the RSC. Michael Billington wrote for "The Guardian" that "Simon seems born to play Cleopatra and she gives us a hypnotically mercurial figure whose eroticism is expressed through a permanent restlessness", although he felt that Simon employed too many voices in the role. Making a similar criticism about the range of accents used, Ian Shuttleworth of the "Financial Times" felt that Simon failed to play to her strengths as an actor, and concluded that "On the occasion of Simon's first RSC appearance this century, she is heartbreaking in all the wrong ways." Ann Treneman of "The Times" felt that Simon, with a performance that was "quite bonkers" at times, provided the highlight of the show, despite a "lamentable lack of chemistry" between her and Anthony Byrne as Antony.


title: Josette Simon

text: In 1992 Simon was the lead, and sang, in David Zane Mairowitz's play "Dictator Gal", broadcast on BBC Radio 3 in 1992. Her character is married to an exiled dictator who is dying in hospital. Simon's character sings a range of songs, including Richard Wagner and Motown compositions in an attempt to revive him.


title: Josette Simon

text: Simon's film appearances include the part of Dr. Ramphele in "Cry Freedom" (1987). She was nominated for a Genie Awards Best Actress award for "Milk and Honey" (1988), in which she played Joanna, who leaves Jamaica with her child to work as a nanny in Toronto. Rick Groen of "The Globe and Mail" wrote that Simons "riveting performance ... carries the picture" for the first part, but felt that from the second act onward, the film descended into histrionics. In the "San Francisco Chronicle", Judy Stone praised Simon's performance as Joanna, commenting that "she displays a quality of grace all too rare in today's films".


title: Josette Simon

text: The 1992 television play "Bitter Harvest" had Simon in the lead role, as a woman who has gone missing after travelling to the Dominican Republic as an aid worker and whose parents go there in search of her. Academic Claire Tylee considered that Simon's character was a "credible protagonist", the film was adversely affected by a mismatch between the thriller plotline from the production's originator Charles Pattinson and the thread about tensions in a mixed race family introduced by Winsome Pinnock, who has joined the project after Simon had already accepted the leading role based on a plot outline by Pattinson. According to Tylee, neither Simon's character or the character of her father "sufficiently resembles the usual hero of a thriller to successfully play on thriller conventions, and the plots end by humiliating both of them, fetishising the black female body along the way."


title: Josette Simon

text: In 1993, Simon starred alongside Brenda Fricker in the two-part television series "Seekers", written by Lynda La Plante. Their characters discover that they are both married to the same man, who has now disappeared. They later work as partners in the detective agency that he had founded. Lynda Gilbey of "Sunday Life" wrote that the show was "a first class detective drama ... beautifully plotted, wonderfully performed". The "Newcastle Journal" reviewer Norman Davison commented that the two lead actresses "invested the roles with the sort of power that all La Plante women seem to have and the men were all the wimps".


title: Josette Simon

text: Benedict Nightingale of The Times wrote in a negative review of Jean Genet's play "The Maids" in 1997 that Simon provided the "one strong performance". In 2019 she appeared as Cynthia in the science fiction series "Nightflyers", and as Grams in the movie "Detective Pikachu". She had a recurring role in "Anatomy of a Scandal" in 2022. Simon has played senior police officers in "Silent Witness" (1998), "Minder" (2009), and "Broadchurch" (2017), and has been cast as Chief Commissioner Camberwell in the "Anansi Boys", which was in production as of May 2022.


title: Josette Simon

text: Simon visits patients, with her dog Milo, through the charity Pets As Therapy, and supports the Kaos Signing Choir for Deaf and Hearing Children. She is a patron of Action Deafness, the Life and Deaf Association, the Deaf Ethnic Women's Association, and Safety Curtain.


title: Josette Simon

text: In 1995, Simon was awarded an honorary Master of Arts degree by the University of Leicester. In the 2000 Birthday Honours she was appointed an Officer of the Order of the British Empire (OBE), for services to drama. She received a Pioneers and Achievers award in 1998, in recognition of being one of the people from Leicester who had "paved the way for the next generations of African Caribbean people to achieve and excel in a diverse range of professions and spheres of influence".


title: Étouffée

text: Étouffée or etouffee (, ) is a dish found in both Cajun and Creole cuisine typically served with shellfish over rice. The dish employs a technique known as smothering, a popular method of cooking in the Cajun and Creole areas of southwest Louisiana. Étouffée is most popular in New Orleans and in the Acadiana region of the southernmost half of Louisiana as well as the coastal counties of Mississippi, Alabama, northern Florida, and eastern Texas.


title: Étouffée

text: In French, the word "étouffée" (borrowed into English as "stuffed" or "stifled") literally means "smothered" or "suffocated", from the verb "étouffer".


title: Étouffée

text: Étouffée is a dish of shellfish, simmered in a sauce made from a light or blond roux, served over rice. It is most commonly made with shellfish, such as crab or shrimp. The most popular version of the dish is made with crawfish. Depending on who is making it and where it is being made it is flavored with either Creole or Cajun seasonings. Although Creole and Cajun cuisines are distinct, there are many similarities.


title: Étouffée

text: In the case of the Creole version of crawfish étouffée, it is made with a blond or brown roux and sometimes tomatoes are added. A blond roux is one that is cooked, stirring constantly, for approximately 5 minutes to remove the "raw" flavor of the flour and to add a slightly "nutty" flavor, while a brown roux is cooked longer (30 to 35 minutes) in order to deepen the color and flavor.


title: Étouffée

text: Around the 1950s, crawfish étouffée was introduced to restaurant goers in Breaux Bridge, Louisiana; however, the dish may have been invented as early as the late 1920s, according to some sources. Originally, crawfish étouffée was a popular dish amongst Cajuns in the bayous and backwaters of Louisiana.


title: Whelk

text: Whelk (also known as scungilli) is a common name applied to various kinds of sea snail. Although a number of whelks are relatively large and are in the family Buccinidae (the true whelks), the word "whelk" is also applied to some other marine gastropod species within several families of sea snails that are not very closely related.


title: Whelk

text: Many have historically been used, or are still used, by humans and other animals as food. In a reference serving of whelk, there are of food energy, 24 g of protein, 0.34 g of fat, and 8 g of carbohydrates.


title: Whelk

text: Dogwinkles, a predatory species, were used in antiquity to make a rich red dye that improves in color as it ages.


title: Whelk

text: True whelks are carnivorous, and feed on annelids, crustaceans, mussels and other molluscs, drilling holes through shells to gain access to the soft tissues. Whelks use chemoreceptors to locate their prey.


title: Whelk

text: The species, genera and families referred to by this common name vary a great deal from one geographic area to another.


title: Whelk

text: In the United States, "whelk" refers to several large edible species in the genera "Busycon" and "Busycotypus", which are now classified in the family Buccinidae. These are sometimes called "Busycon whelks".


title: Whelk

text: In addition, the unrelated invasive murex "Rapana venosa" is referred to as the "Veined rapa whelk" or "Asian rapa whelk" in the family Muricidae.


title: Whelk

text: In Brazil, there is a very popular Afro-Brazilian divination game practiced by older women of African ancestry called "jogo de búzios" (game of whelks), which uses empty shells of these gastropods.


title: Whelk

text: In the British Isles, Belgium and the Netherlands ("wulk"/"wullok"), the word is used for a number of species in the family Buccinidae, especially "Buccinum undatum", an edible European and Northern Atlantic species.


title: Whelk

text: In the British Isles, the common name "dog whelk" is used for "Nucella lapillus" (family Muricidae) and for "Nassarius" species (family Nassariidae). Historically, they were a popular street food in Victorian London, typically located close to public houses and theatres.


title: Whelk

text: In Scotland, the word "whelk" is also used to mean the periwinkle ("Littorina littorea"), family Littorinidae.


title: Whelk

text: In the English-speaking islands of the West Indies, the word "whelks" or "wilks" (this word is both singular and plural) is applied to a large edible top shell, "Cittarium pica", also known as the "magpie" or "West Indian top shell", family Trochidae.


title: Whelk

text: In Japan, are frequently used in sashimi and sushi. In Vietnam, they are served in a dish called "Bún ốc" - vermicelli with sea snails. "" () is a Korean dish consisting of whelks and with chili sauce in a salad with cold noodles. It has been a very popular side dish with alcohol for many generations.


title: Whelk

text: In Australia and New Zealand, species of the genus "Cabestana" (family Ranellidae) are called "predatory whelks", and species of "Penion" (family Buccinidae) are called "siphon whelks".


title: History of Kenya

text: A part of Eastern Africa, the territory of what is known as Kenya has seen human habitation since the beginning of the Lower Paleolithic. The Bantu expansion from a West African centre of dispersal reached the area by the 1st millennium AD. With the borders of the modern state at the crossroads of the Bantu, Nilo-Saharan and Afro-Asiatic ethno-linguistic areas of Africa, Kenya is a truly multi-ethnic state.


title: History of Kenya

text: The European and Arab presence in Mombasa dates to the Early Modern period, but European exploration of the interior began in the 19th century. The British Empire established the East Africa Protectorate in 1895, from 1920 known as the Kenya Colony.