GOST ISO 10993-9-2015 Medical devices Biological evaluation of medical devices Part 9 Framework for identification and quantification of potential degradation products《医疗器械 医疗器械的生物.pdf

上传人:lawfemale396 文档编号:775169 上传时间:2019-01-23 格式:PDF 页数:16 大小:359.54KB
下载 相关 举报
GOST ISO 10993-9-2015 Medical devices Biological evaluation of medical devices Part 9 Framework for identification and quantification of potential degradation products《医疗器械 医疗器械的生物.pdf_第1页
第1页 / 共16页
GOST ISO 10993-9-2015 Medical devices Biological evaluation of medical devices Part 9 Framework for identification and quantification of potential degradation products《医疗器械 医疗器械的生物.pdf_第2页
第2页 / 共16页
GOST ISO 10993-9-2015 Medical devices Biological evaluation of medical devices Part 9 Framework for identification and quantification of potential degradation products《医疗器械 医疗器械的生物.pdf_第3页
第3页 / 共16页
GOST ISO 10993-9-2015 Medical devices Biological evaluation of medical devices Part 9 Framework for identification and quantification of potential degradation products《医疗器械 医疗器械的生物.pdf_第4页
第4页 / 共16页
GOST ISO 10993-9-2015 Medical devices Biological evaluation of medical devices Part 9 Framework for identification and quantification of potential degradation products《医疗器械 医疗器械的生物.pdf_第5页
第5页 / 共16页
点击查看更多>>
资源描述

1、 . 9 (ISO 10993-9:2009, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)ISO 10993-92015, - 1.092 . 1.22009 . -, . , , 1 - ( ) - , 52 (-)3 , ( 27 2015 . 76-) : ( 3166) 00497 ( 3166) 00497 BYKZKGMDRUTJ -4 27 2015 . 294-c 1 2016 .5 ISO 10993-9:2009 Biologicalevaluation

2、of medical devices Part 9: Framework for identification and quantification of potential degradationproducts ( . 9. - ). (en). - . (IDT)6 ISO 10993-92011-, - . () . , - - , 2015 -, II ISO 10993-920151 .12 13 24 .24.1 24.2 34.3 .34.4 35 .4() . 5B() .7() 8 9III ISO 10993-92015 ISO 10993 - - . - - . , -

3、, . ISO 10993 - , - , . ISO 10993 : 1. ; 2. ; 3. , , -; 4. , ; 5. : in vitro; 6. ; 7. ; 9. ; 10. ; 11. ; 12 ; 13. - ; 14. ; 15. ; 16. - ; 17. ; 18. ; 19. -, ( ); 20. ( ). , , - ISO 10993-13 ( ), ISO 10993-14 ( ) ISO 10993-15 ( )., , ., , - , -. , - , - - . - . , . - .IV ISO 10993-92015 - -. , / . -

4、., , .V ISO 10993-92015 . 9 Medical devices. Biological evaluation of medical devices.Part 9. Framework for identification and quantification of potential degradation products1 . , , , - ISO 10993. , . :- . - . - . ISO 10993, , , , ISO 10993;- , ;- ,. , , ISO 10993-1, , , - - .2 , -, . - . , . . - .

5、1 ISO 10993-92015 20160601ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a riskmanagement process ( . 1. - )ISO 10993-2 Biological evaluation of medical devices Part 2: Animal welfare requirements ( . 2. )ISO 10993-13 Biological evaluation of medical devic

6、es Part 13: Identification and quantification ofdegradation products from polymeric medical devices ( -. 13. - )ISO 10993-14 Biological evaluation of medical devices Part 14: Identification and quantification ofdegradation products from ceramics ( . 14. )ISO 10993-15 Biological evaluation of medical

7、 devices Part 15: Identification and quantification ofdegradation products from metals and alloys ( . 15. )3 ISO 10993-1, - :3.1 : .3.2 : .3.3 : , .3.4 : , - .3.5 : - . . .3.6 : , .3.7 : .3.8 : , .3.9 : , , .4 4.1 , , . , , . , , . , in vitro - , . - , ISO 10993-13 , ISO 10993-14 ISO 10993-15 - . , , - .2 ISO 10993-92015ISO 10993-13, ISO 10993-14 ISO 10993-15 , - . -, , . .4.2 - ,

展开阅读全文
相关资源
猜你喜欢
相关搜索

当前位置:首页 > 标准规范 > 国际标准 > GOST

copyright@ 2008-2019 麦多课文库(www.mydoc123.com)网站版权所有
备案/许可证编号:苏ICP备17064731号-1