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| GB/T 16886.17-2005 | Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ17²¿ÃÅ£º¿ÉÁ¤ÂËÎïÔÊÐíÏÞÁ¿µÄ½¨Á¢ | |
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| GB 18280.3-2015 | Ò½ÁƱ£½¡²úÎïÃð¾ú ·øÉä µÚ3²¿ÃÅ£º¼ÁÁ¿ÕÉÁ¿Ö¸ÄÏ | |
| GB/T 16886-7-2015 | Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ7²¿ÃÅ£º»·ÑõÒÒÍéÃð¾ú²ÐÁôÁ¿ | |
| WS 310.1 / WS 310.2 / WS 310.3/WS/T 367 / GB 18278.1/ YY/T 0734 / YY/T 1495 | ÇåÏ´Ïû¶¾Ãð¾úÑéÖ¤ | |
| °ü×°ÔËÊä | GB /T 4857 | °ü×°ÔËÊäÊÔÑé |
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| YY/T 0076-1992 | ½ðÊôÖƼþµÄ¶Æ²ã·ÖÀà ¼¼ÊõÌõ¼þ | |
| GB 2024-2016 | Õë¾ÄÕë |
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| ÉúÎïÏàÈÝÐÔ | ISO 10993-1:2018 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 10993-5:2009 | Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity | |
| ISO 10993-10:2021 | Biological evaluation of medical devices Part 10: Tests for skin sensitization | |
| ISO 10993-11:2017 | Biological evaluation of medical devices Part 11: Tests for systemic toxicity | |
| ISO 10993-23:2021 | Biological evaluation of medical devices Part 23: Tests for irritation | |
| ISO 10993-17:2023 | Toxicological risk assessment of medical device constituents | |
| ISO 10993-18:2020/Amd 1:2022 | Determination of the uncertainty factor | |
| ÎÞ¾úÒ½ÁÆÆ÷е°ü×°ÑéÖ¤ | ASTM F1980-2016 | ¼ÓËÙÀÏ»¯ÊÔÑé |
| ASTM F88/F88M-2015 | ÈíÐÔÆÁÕÏÖÊÁϵÄÃÜ·âÇ¿¶È | |
| ASTM F1140-2013 | ÎÞÔ¼Êø°ü×°¿¹ÄÚѹÆÆ»µ | |
| ASTM F1929-15 | ȾɫҺ´©Í¸·¨²â¶¨Í¸Æø°ü×°µÄÃÜ·âй© | |
| ISO 11607-1-2019 ¸½Â¼B£»ASTM F2096-11 | ÄÚѹ·¨¼ì²â´Ö´óй©£¨ÆøÅÝ·¨£© | |
| ASTM F1886/F1886M-16 | Ä¿Á¦¼ì²âÒ½Óðü×°ÃÜ·âÍêÕûÐÔ | |
| ISO 11607-1:2019 5.2 | ͸Æø°ü×°ÖÊÁÏʪÐԺ͸ÉÐÔ΢ÉúÎïÆÁÕÏÊÔÑé | |
| °ü×°ÔËÊä | ISTAϵÁÐ;ASTM D4169 | °ü×°ÔËÊä |
| Ãð¾úÑéÖ¤ | ISO 11135 | Ò½ÁƱ£½¡²úÎïÃð¾ú »·ÑõÒÒÍé Ò½ÁÆÆ÷еÃð¾ú¹ý³Ì¿ª·¢¡¢È·ÈϺÍͨÀý¿ØÖÆÒªÇó |
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| ISO11137-2 | Ò½ÁƱ£½¡²úÎïÃð¾ú ·øÉäµÚ2²¿ÃŽ¨Á¢Ãð¾ú¼ÁÁ¿ | |
| ISO 10993-7 | Ò½ÁÆÆ÷еÉúÎïѧÆÀ¼Û µÚ7²¿ÃÅ »·ÑõÒÒÍé²ÐÁôÁ¿ | |
| ISO 11607-1 | ×îÖÕÃð¾úÒ½ÁÆÆ÷е°ü×° µÚ1²¿ÃÅ£ºÖÊÁÏ¡¢ÎÞ¾úÆÁÕÏϵͳºÍ°üװϵͳµÄÒªÇó | |
| ISO 11607-2 | ×îÖÕÃð¾úÒ½ÁÆÆ÷е°ü×° µÚ2²¿ÃÅ£º³ÉÐΡ¢ÃÜ·âºÍ×°Åä¹ý³Ì¼òÖ±ÈϵÄÒªÇó | |
| ISO 11737-1 | Ò½ÁƱ£½¡²úÎïÃð¾ú ΢ÉúÎïѧҪÁì µÚ1²¿ÃÅ ²úÎï΢ÉúÎïÊýÁ¿µÄ²â¶¨ | |
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