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YY/T 1474-2016 Medical Devices Application of Usability Engineering to Medical Devices

YY/T 1474-2016 Medical Devices Application of Usability Engineering to Medical Devices
YY/T 1474-2016 Medical Devices Application of Usability Engineering to Medical Devices
US$21.55
  • Stock: 100
  • Model: 35085815548
  • Weight: 0.30kg
  • Dimensions: 50.00cm x 50.00cm x 50.00cm
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YY/T 1474-2016
医疗器械可用性工程对医疗器械的应用
【标准编号】 YY/T 1474-2016
【标准名称】 医疗器械可用性工程对医疗器械的应用
【出版单位】 中国标准出版社
【ICS分类】 11.040
【发布部门】 国家食品药品监督管理总局
【发布日期】 2016年1月26日
【实施日期】 2017年1月1日
【出版日期】 2017年3月
【标准定价】 92.00 元
 
相关公告

 [2016-1-26]

内容简介   引用标准  
本标准规定了制造商分析、确定、设计、验证和确认可用性的过程，因为这关系到医疗器械的安全。可用性工程过程用于评定和降低由正确使用和使用错误等正常使用相关的可用性问题引起的风险。能用于识别但不用于评定或降低与非正常使用有关的风险。 
如果已经符合本标准中详细规定的可用性工程过程，并满足在可用性确认计划中形成文件的可接受准则，则可认为YY/T 0316中规定的与医疗器械可用性有关的剩余风险是可接受的，除非有相反的客观证据。 
本标准不适用于与医疗器械使用有关的临床决策。 

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Women's Clothing (Coats & Jackets, Dresses, T-Shirts, Tops, Suits)
Standard Size
China (cm) 160-165/84-86 165-170 / 88-90 167-172 / 92-96 168-173 / 98-102 170-176 / 106-110
International XS S M L XL
USA 2 4-6 8-10 12-14 16-18
Europe 34 34-36 38-40 42 44
Bra - Under bust
Standard Size
China
(cm)		 76.2 81.3 86.4 91.5 96.5 101.6 106.7 112 117 122 127 132 137 142
USA 30 32 34 36 38 40 42 44 46 48 50 52 54 56
UK 30 32 34 36 38 40 42 44 46 48 50 52 54 56
Europe   70 75 80 85 90                
France   85 90 95 100 105                
Italy   1 2 3 4 5                
Bra - Cup size
Standard Size
China A B C D E                  
USA AA A B C D DD DDD/E F FF G GG H HH J
UK AA A B C D DD E F FF G GG H HH J
Europe AA A B C D E F              
France AA A B C D E F              
Italy   B B/none C D DD E F            
Women's Underwear
Standard Size
China S M L XL XXL XXXL
International XS S M L XL XXL
USA 2 4 6 8 10 12
UK 6 8 10 12 14 16
Europe 32 34 36 38 40 42
France 34 36 38 40 42 44
Italy 38 40 42 44 46 48
Women's Shoes
Standard Size
Length (cm) 22.8 23.1 23.5 24.1 24.5 25.1 25.7 26 26.7 27.3 27.9 28.6 29.2
China 35.5 36 37 38 39 40 41.5 42 43 44.5 46 47 48
USA 5 5.5 6 7 7.5 8.5 9.5 10 10.5 12 13 14 15.5
UK 2.5 3 3.5 4.5 5 6 7 7.5 8 9.5 10.5 11.5 13
Europe 35 35.5 36 37.5 38 39 41 42 43 44 45 46.5 48.5
Men's Clothing (Coats & Jacketst,T-Shirts,Suits)
Standard Size
China (cm) 165 / 88-90 170 / 96-98 175 / 108-110 180 / 118-122 185 / 126-130
International S M L XL XXL
Men's Clothing (Shirts)
Standard Size
China (cm) 36 - 37 38 - 39 40 - 42 43 - 44 45 - 47
International S M L XL XXL
Men's Clothing (Pants)
Size (cm) 42 44 46 48 50
Waist (cm) 68 - 72 cm 71 - 76 cm 75 - 80 cm 79 - 84 cm 83 - 88 cm
Outseam (cm) 99 cm 101.5 cm 104 cm 106.5 cm 109 cm
Men's Underwear
Standard Size
China(cm) 72-76 76-81 81-87 87-93 93-98
International S M L XL XXL
USA(inch) 28-30 30-32 32-34 34-38 38-42
Men's Shoes
Standard Size
Length(cm) 24.5 25.1 25.7 26 26.7 27 27.6 28.3 28.6 28.9
China 39.5 41 42 43 44 44.5 46 47 47.5 48
USA 6 7 8 8.5 9.5 10 11 12 12.5 13
UK 5.5 6.5 7.5 8 9 9.5 10.5 11.5 12 12.5
Europe 38 39 41 42 43.5 44 45 46 46.5 47
长度Length
Imperial英制 Meric公制
1 inch[in] 英寸 ---- 2.54 cm 厘米
1 foot[ft] 英尺 12 in 英寸 0.03048 m 米
1 yard[yd] 码 3 ft 英尺 0.9144 m 米
1 mile[mi] 英里 1760 yd 码 1.6093 km 千米
1 int nautical mile[inm] 海里 2025.4 yd 码 1.853 km 千米
面积Area
Imperial英制 Meric公制
1 sq inch[in2] 平方英寸 ---- 6.4516 cm2 平方厘米
1 sq foot[ft2] 平方英尺 144 in2 平方英寸 0.0929 m2 平方米
1 sq yard[yd2] 平方码 9 ft2 平方英尺 0.8361 m2 平方米
1 acre 英亩 4840 yd2 平方码 4046.9 m2 平方米
1 sql mile[mile2] 平方英里 640 acre 英亩 2.59 km2 平方千米
体积/容量Volume/Capacity
Imperial英制 Meric公制
1 fluid ounce 液量蛊司 1.048 UK fl oz 英制液量蛊司 29.574 ml 毫升
1 pint(16 fl oz 液量品脱)品脱 0.8327 UK pt 英制品脱 0.4731 l 升
1 gallon 加仑 0.8327 UK gal 英制加仑 3.7854 l 升
重量Weight
Imperial英制 Meric公制
1 ounce[oz]蛊司 437.5 grain 格令 28.35 g 克
1 pound[lb]磅 16 oz 蛊司 0.4536 kg 千克
1 stone 石 14 lb 磅 6.3503 kg 千克
1 hundredweight[cwt] 英担 112 lb 磅 50.802 kg 千克
1 long ton(UK) 长顿 20 cwt 英担 1.061 t 顿