GOST R 56033-2014 Guide to the development and inclusion of safety aspects in international standards for medical devices《国际医疗器械标准中安全方面的发展和融合指南》.pdf

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1、 560332014/ 63:2012 ISO/IEC Guide 63:2012Guide to the development and inclusion of safety aspects in international standardsfor medical devices(IDT) 1 ( ) ,42 436 -3 -42014.502-4 / 63:2012- (ISO/IEC Guide 63:2012 Guide to the development and inclusion of safety aspects ininternationalstandardsformed

2、icaldevices)5 1.02012 ( 8). (1 ) , -.()- .,- (gost.ru),2014 , -II 560332014/ / 63:20121 .12 13 .33.1 33.2 .33.3 .43.4 53.5 .53.6 63.7 63.8 63.9 64 , . 64.1 64.2 , .74.3 74.4 .74.5 .84.6 .94.7 114.8 .114.9 .124.10 .124.11 135 14971 -135.1 135.2 .135.3 14971 .14A() .16B() 1718III 560332014/ / 63:2012

3、/ 63 / 210 - / 62 , . (ISO/IEC Guide 63:1999), . , , , - , . - , , . , , - . , , , , .IV 560332014/ / 63:2012 Guide to the development and inclusion of safety aspects in international standards for medical devices 201506011 , , 14971. , / 51, - , . / 51 14971.2 :2.1 (accompanying document): , - , ,

4、 , , . 14971, 2.12.2 (harm):,/ 51, 3.32.3 (hazard): . (, , - , , , )./ 51, 3.52.4 (hazardous situation): , , ./ 51, 3.62.5 / (intended use): , , - , . 14971, 2.52.6 (life-cycle): , - . 14971, 2.71 560332014/ / 63:2012 2.7 (manufacturer): , -, , / , / ,.1 .2 . 13485, 3.6. 14971, 2.82.8 (medical devi

5、ce): , , , , , in vitro , , , :- , , , ;- , , , ;- , -;- ;- ;- ;- in vitro , , , - , , - .1 (Global HarmonizationTask Force GHTF).2 , :- ;- / ;- ;- ;- , , - , .3 13485, 3.7, 14971, 2.9.2.9 (residualrisk):,.1 / 51, 3.9, - .2 14971, 2.15.2.10 (risk): ./ 51, 3.22.11 (risk analysis): ./ 51, 3.10 , .2.12

6、 (risk control): - . 14971, 2.192.13 (risk estimation): , - . 14971, 2.202 560332014/ / 63:20122.14 (risk evaluation): , , . 14971, 2.212.15 (risk management): , , , - . 14971, 2.222.16 (safety): ./ 51, 3.12.17 (severity): . 14971, 2.252.18 (usability): -, , , . 62366, 3.172.19 / (use error): , , - . 1 / , . 2 . C D, D.1.3. 3 /. 62366, 3.212.20 (verification): - , . 1 . 2 :- ;- ;- ;- . 9000, 3.8.43 3.1 - , . :) ;b) , , , - ;c) , . , - , (. 4).3.2 - , , , - . ( ), , - . -3 560332014/ / 63:2012 . :- , , - ,- , ( );- , , - , , , , - ;- , , - ;

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