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5、 . 2. )ISO 10993-11 Biological evaluation of medical devices Part 11: Tests for systemic toxicity ( . 11. )1 ISO 10993-62011 20130101ISO 10993-12 Biological evaluation of medical devices Part 12: Sample preparation and referencematerials ( . 12. - )ISO 10993-16 Biological evaluation of medical devic
6、es Part 16: Toxicokinetic study design fordegradation products and leachables ( . 16. )3 ISO 10993-1, ISO 10993-2, ISO 10993-12,ISO 10993-16, :3.1 : ISO 10993-9, 3.13.2 : , - ISO 10993-16, 3.13.3 : , , , .4 4.1 , (. ISO 10993-2,ISO 10993-11 ISO 10993-16). , - . - , ISO 10993-2. , B,CD.4.2 ISO 10993-12. . B, C D. - ( , , , ), - , . , - , , -. , ., () -, , - . (, - ) . , in situ, . . -.,- , (. ISO 10993-12, ). 2 ISO 10993-62011 , . , . . , . 1 (), () - (). . , -, . , , - , , - .
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