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²ÄÁÏÉúÎïÏàÈÝÐÔÆÀ¼Û±ê×¼£¬ISO10993Ìåϵ½éÉÜÈçÏ£º 1.ISO 10993-1:2009 ·çÏÕ¹ÜÀí³ÌÐòÖÐµÄÆÀ¼ÛºÍ²âÊÔ Biological evaluation of medical devices Part 1: Evaluation and testing in the risk management process 2.ISO 10993-2:2006 ¶¯Îï±£»¤ÒªÇó Biological evaluation of medical devices Part 2: Animal welfare requirements 3.ISO 10993-3:2003 ÒÅ´«¶¾ÐÔ¡¢Ö°©¶¾ÐÔºÍÉúÖ³¶¾ÐÔÊÔÑé Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity 4.ISO 10993-4:2002/Amd 1:2006 ÓëѪҺÏ໥×÷ÓÃÊÔÑéÑ¡Ôñ Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood 5.ISO 10993-5:2009 ÌåÍâϸ°û¶¾ÐÔÊÔÑé Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity 6.ISO 10993-6:2007 Ö²Èëºó¾Ö²¿·´Ó¦ÊÔÑé Biological evaluation of medical devices Part 6: Tests for local effects after implantation 7.ISO 10993-7:2008 »·ÑõÒÒÍé²ÐÁôÏÞÁ¿ Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals 8.ISO 10993-8:2001 ÉúÎïÊÔÑéÓòο¼²ÄÁϵÄÑ¡ÔñºÍÌõ¼þ Biological evaluation of medical devices Part 8: Selection of reference materials 9.ISO 10993-9:1999 DZÔÚ½µ½â²úÎﶨÐÔÓ붨Á¿¿ò¼Ü Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products 10.ISO 10993-10:2010 ´Ì¼¤ºÍƤ·ôÃô»¯ÊÔÑé Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity 11.ISO 10993-11:2006 È«Éí¶¾ÐÔÊÔÑé Biological evaluation of medical devices Part 11: Tests for systemic toxicity 12.ISO 10993-12:2012 ÑùÆ·ÖÆ±¸Óë²ÎÕÕÑùÆ· Biological evaluation of medical devices Part 12: Sample preparation and reference materials (available in English only) 13.ISO 10993-13:1998 ¾ÛºÏÎïÒ½ÁÆÆ÷еµÄ½µ½â²úÎﶨÐÔÓ붨Á¿·ÖÎö Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices 14.ISO 10993-14:2001 Ìմɽµ½â²úÎﶨÐÔÓ붨Á¿·ÖÎö Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics 15.ISO 10993-15:2000 ½ðÊôÓëºÏ½ð½µ½â²úÎﶨÐÔÓ붨Á¿·ÖÎö Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys 16.ISO 10993-16:1997 ½µ½â²úÎïÓë¿ÉÁ¤ÂËÎï¶¾ÐÔ¶¯Á¦Ñ§Ñо¿Éè¼Æ Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables 17.ISO 10993-17:2002 ÔÊÐí¿ÉÁ¤ÂËÎïÏÞÖÆµÄ½¨Á¢ Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances 18.ISO 10993-18:2005 ²ÄÁϵĻ¯Ñ§ÌØÐÔ Biological evaluation of medical devices Part 18: Chemical characterization of materials 19.ISO/TS 10993-19:2006 ²ÄÁϵÄÎïÀí»¯Ñ§¡¢ÐÎ̬ѧºÍµØÐÎÑ§ÌØÕ÷ Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials 20.ISO/TS 10993-20:2006 Ò½ÁÆÆ÷еµÄÃâÒß¶¾ÐÔ²âÊÔÔÔòºÍ·½·¨ Biological evaluation of medical devices Part 20: Principles and methods for immunotoxicology testing of medical devices |
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