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

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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 - - . - - . , -

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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 - ,

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