GOST R ISO 25539-1-2012 Cardiovascular implants Endovascular devices Part 1 Endovascular prostheses《心血管植入物 血管内装置 第1部分 血管内假体》.pdf

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1、2014 - 1 ISO 25539-1:2003 Cardiovascular implants Endovascular devices Part 1: Endovascular prostheses (IDT) 25539-1 2012 25539-12012II1 - . . . ( . . . ) , - 42 3 - 30 2012 266-c 01 2014 .4 255391:2003 - -c. . 1. (ISO 255391:2003 Cardiovascular implants Endovascular devices Part 1: Endovascular pro

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3、.19 A () . 20 B () 29 C () , . .32 D () 35 E () D.5.3.19. ( ): .60 () 62 64 25539-12012 1 201401011 1.1 - . -, , , , , -, , , . 14630, .1.2 , , .1.3 , - .1.4 , , - . . 14630.1.5 , (. 3.6), , , .2 -. . ( ). 7198:1998 - . (ISO 7198:1998, Cardiovascular implants Tubular vascular prostheses) 11134:1994

4、. -. (ISO 11134:1994, Sterilization of health care products Re-quirements for validation and routine control Industrial moist heat sterilization) 11135:1994 . (ISO 11135:1994, Medical devices Validation and routine control of ethylene oxide sterilization) 11137:1995 . -. (ISO 11137:1995, Sterilizati

5、on of health care products Requirements for validation and routine control Radiation sterilization) 10993 ( ) (ISO 10993 (all parts), Biologi-cal evaluation of medical devices) - 1 Cardiovascular implants. Endovascular devices. Part 1. Endovascular prostheses 25539-120122 11607:1997 , (ISO 11607:199

6、7, Packaging for terminally sterilized medical devices) 13485 . . - (ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes) 13488:1996 . . - 9002 (ISO 13488:1996, Quality systems Medical devices Particular requirements for the application of ISO 9002) 14155 ( ) (

7、ISO 14155 (all parts), Clinical investigation of medical devices for human subjects) 14160 , - . (ISO 14160, Sterilization of single-use medical devices incorporating materials of animal origin Validation and routine control of sterilization by liquid chemical sterilants) 14630:1997 . (ISO 14630:199

8、7, Non-active surgical implants General requirements) 14937 . - , (ISO 14937, Sterilization of health care products General requirements for charac-terization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices) 14971:2000 . - (IS

9、O 14971:2000, Medical devices Application of risk management to medical devices)3 7198 14630, - :3.1 : , , - . - .3.2 : , . .3.3 : .3.4 : -, , - . :- I ;- II ;- III ;- IV , .3.5 , , : , , - .3.6 : , , (-) , . 1 , , . 2 , , . 25539-1201233.7 : .3.8 : .3.9 , : , .4 14630, 4, .5 5.1 14630, 5. , - :a) : ;b) : ;c) :1) , ;2) ;3) , ;4) , ;d) , , ;e) . 5 E 120063.5.2 :a) , - ;b) , ;c) ;d) 109931 10993;e) ;f) .5.3 , - , :a) ;b) ;c) ;d) ; .e) () ;f) - ;g) ();h) - - ();i) 109931 10993;j) . 25539-1201246 14630, 6, . , , , .7 7.1 14630, 7, . 14971. . , - . , . , - . , - , , . - . , 7198, - 3.9, , -. .