ISO 10993 | 合法醫療器材資訊網

This corrected version of ISO 10993-1:2018 incorporates the following correction. ... ISO 10993-2:2006, Biological evaluation of medical devices — Part 2: Animal ... /en_GB/document_library/Scientific_guideline/2009/09/WC500002903.pdf. Read More

ISO 10993-1:2018. Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process ... Read More

ISO 10993-1:2018(E). ISO 10993-3, Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity. Read More

2020年9月4日 — ISO 10993 - Part 1 and the FDA-Modified Matrix . ... Standard ISO-10993, '​Biological Evaluation of Medical Devices - Part 1: ... A-1, pdf p.x/200). Read More

ISO 2018. Biological evaluation of medical devices —. Part 1: Evaluation and testing ... 10993-1. Fifth edition. 2018-08. Reference number. ISO 10993-1:2018(​E). Read More

4. 規格或宣稱特殊功能、療效：最後則是針對製造廠所提供的產品仿單內容：一般指型錄Catalog、使用說明書Instruction for use、操作手冊Operation manual等， ... Read More

Details of the software products used to create this PDF file can be found in the ... ISO 10993-3, Biological evaluation of medical devices — Part 3: Tests for ... Read More

Standard ISO 10993, Biological evaluation of medical device part 1: Evaluation and testing」. ISO 10993-1:2009/Cor 1:2010. 醫療器材生物相容性國際標準 ... Read More