1、 1 , (EN 556-1:2001, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)EN 556-12011, 1.092 . 1.22009 . , - . , , -, . 1 - ()2 E 3 , (- 29 2011 . 40) : ( 3166) 00497 ( 3166) 00497 BYKZKGRU 4 13 2011 . 1368- EN 556-12011 1 2013 .5 EN 556-1:2001Sterilization of medical de
2、vices Requirements for medical devices to be designated STERILE Part 1:Requirements for terminally sterilized medical devices ( . . 1. , - ). - .C (IDT). EH 556-120096 E -, - . () . , - - , 2014 -, II EN 556-120111 12 13 14 .2 ZA () , 3 () 4 .5III EN 556-12011 , .-, . , , , (. EN ISO 13485:2000 EN I
3、SO 13488:2000), . () ,. / , , - . , , - . , , -. , () , . () . - , , . - . . , ., , , - . , - () / , , , , .IV EN 556-12011 1 , Sterilization of medical devices. Requirements for medical devices to be designated sterile. Part 1. Requirements forterminally sterilized medical devices 201301011 , , . E
4、N 556-2 - , , - . , (. -), , - . EN 550, EN 552, EN 554, EN ISO 14160 EN ISO 14937.2 -*:EN ISO 13485:2000 Qualitysystems Medical devices Particular requirements for the application ofEN/ISO 9001 (revision of EN 46001:1996) (identical to ISO 13485:1996) ( . . EN/ISO 9001 ( EN 46001:1996) ( ISO 13485:
5、1996)EN ISO 13488:2000 Qualitysystems Medical devices Particular requirements for the application ofEN/ISO 9002 (revision of EN 46002:1996) (identical to ISO 13488:1996) ( . . EN/ISO 9002 ( EN 46002:1996) ( ISO 13488:1996)3 : , , - .3.1 (bioburden): /.* . - , .1 EN 556-12011 3.2 (medical device): ,
6、, , , , ,- :- , , , ;- , , , ;- , , ;- . , , .3.3 (sterility): C, -.3.4 (sterile): , - .3.5 (terminally-sterilized): , , - , .4 4.1 , , , , , () - 1 c180 106. , , , - . , , , (., , EN ISO 14971) (:2006).4.2 - , -, , 4.1. , EN ISO 13485, 4.5 4.16, EN ISO 13488, 4.5 4.16. 1 :1) , -, ;2) , , , - . 2 -,
7、 , - .2 EN 556-12011 ZA() , , - , 93/94/.: , , . 90/385/, 93/42/ 98/79/ - , ZA.1. , - . ZA.1 93/42/, 1 90/385/, 1 98/79/, 14.1 1, 8.1, 13.3 () 1,7,14.1, 1, 2.1, 8.2 ()4.2 8.4 2.43 EN 556-12011 () .1 cc EN ISO 13485:2000 - . . - - EN/ISO 9001ISO 13485:2003 -. - . -IDT ISO 134852011 . - . - (ISO 13485
8、:2003, IDT)EN ISO 13488:2000 - . . - - EN/ISO 9002 * . - . . :- IDT .4 EN 556-120111 EN ISO 9001:1994 Quality systems Model for quality assurance in design/development, production, installationand servicing ( . , , )2 EN ISO 9002:1994 Quality systems Model for quality assurance in production, instal
9、lation and servicing (- . , )3 EN 550 Sterilization of medical devices Validation and routine control of ethylene oxide sterilization( . )4 EN 552 Sterilization of medical devices Validation and routine control of sterilization irradiation (- . -)5 EN 554 Sterilization of medical devices Validation and routine control of sterilization moist heat (- . )6 EN 980
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