GOST ISO 10993-17-2011 Medical devices Biological evaluation of medical devices Part 17 Establishment of allowable limits for leachable substances《医疗器械 医疗器械的生物学评价 第17部分 可滤取物质允许限度的建.pdf

《GOST ISO 10993-17-2011 Medical devices Biological evaluation of medical devices Part 17 Establishment of allowable limits for leachable substances《医疗器械 医疗器械的生物学评价 第17部分 可滤取物质允许限度的建.pdf》由会员分享，可在线阅读，更多相关《GOST ISO 10993-17-2011 Medical devices Biological evaluation of medical devices Part 17 Establishment of allowable limits for leachable substances《医疗器械 医疗器械的生物学评价 第17部分 可滤取物质允许限度的建.pdf（42页珍藏版）》请在麦多课文档分享上搜索。

1、 , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) 17 (ISO 10993-17:2002, IDT) 2013 ISO 10993-17 2011 IS 10993-172011 II , 1.092 . 1.22009 . , . , , , 1 - () 2 () 3 , ( 40-2011 29 2011 .) : ( 3166) 00497 ( 3166) 00497 BY KZ KG RU UZ TJ 4 13 2011 . 1300- ISO 10993-172011

2、1 2013 . 5 ISO 10993-17:2002 Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances ( . 17. ). . (IDT). 10993-172009 6 IS 10993-172011 III ( ) . , . C, 2013 , IS 10993-172011 V ISO 10993 . . , -, . ISO 10993 , , . ISO 10993 : 1 ; 2 ; 3 , ; 4 , ;

3、5 : in vitro; 6 ; 7 ; 9 ; 10 ; 11 ; 12 ; 13 ; 14 ; IS 10993-172011 VI 15 ; 16 ; 17 ; 18 ; 19 -, ; 20 . . , , . , , , . ISO 10993 , . , , , . , . . ISO , , ( ) . , , , , ISO 10993 IS 10993-172011 VII . IS 10993-172011 1 17 Medical devices. Biological evaluation of medical devices. Part 17. Establishm

4、ent of allowable limits for leachable substance 20130101 1 ( ) , . . , . , (, in vitro ). , , , . . 2 , IS 10993. IS 10993-172011 2 , , ISO 10993, , . . IS IEC . ISO 10993-1:2003 Biological evaluation of medical devices Part 1: Evaluation and testing (O . 1. ) 3 ISO 10993-1, : 3.1 ( ), : , , . . , ,

5、 . . 3.2 , : , , . 3.3 , : , , . . 3.4 : , , , . 3.5 : / . 3.6 : . 3.7 : . 3.8 : . IS 10993-172011 33.9 : . 3.10 : , , . , , , , , , , , , , , , . 3.11 , : , , , , , . , , , , . 3.12 , : , . , , (), (). 3.13 , : UF1, UF2 UF3. 3.14 : , , . 3.15 , : , . , , (), (). 3.16 , : , IS 10993-172011 4 , , , , . , , , , . 3.17 , : , . . 3.18 , : , , . T . 3.19 : . 3.20 : . 3.21 : . 3.22 , : . . 3.23 - , TC: 4, 5 6. 3.24 , TE: ,