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	CNS 15013 - English Version Medical devices - Quality management systems - Requirements for regulatory purposes 用於法規目的之醫療器材品質管制系統要求 - 英文版
	CNS 14393-13 - English Version Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical 醫療器材生物性評估－第13部：聚合物醫療器材降解產物之鑒別及定量 - 英文版
	CNS 15758-1 - English Version Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging 最終滅菌醫療器材之包裝－第1部：材料、無菌屏障系統及包裝系統之要求 - 英文版
	CNS 14393-9 - English Version Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products 醫療器材生物性評估－第9部：潛在降解產物之鑒別及定量分析架構 - 英文版
	CNS 14393-8 - English Version Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests 醫療器材生物性評估－第8部：生物測試用參考材料之選擇及資格認定 - 英文版
	CNS 14393-2 - English Version Biological evaluation of medical devices－part 2：Animal welfare requirements 醫療器材生物性評估－第二部分：動物福利之規定 - 英文版
	CNS 14393-15 - English Version Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys 醫療器材生物性評估－第15部：金屬及合金之降解產物的鑒別及定量 - 英文版

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