"Medical devices" CNS Standards List |
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CNS 62366-1
2021 Edition Medical devices − Part 1: Application of usability engineering to medical devices 醫療器材－第1部：醫療器材可用性工程之應用 |
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CNS 15267
2020 Edition Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices 醫療器材－醫療器材安全與性能選擇之指導綱要 |
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CNS 14393-20
2020 Edition Biological evaluation of Medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices 醫療器材生物性評估－第２０部：醫療器材免疫毒理學試驗之原理與方法 |
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CNS 15758-1
2019 Edition Packaging for terminally sterilized Medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems 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 |
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CNS 14393-1
2018 Edition Biological evaluation of Medical devices – Part 1：Evaluation and testing 醫療器材生物性評估－第一部分：評估與試驗 |
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CNS 14393-7
2018 Edition Biological evaluation of Medical devices - Part 7: Ethylene oxide sterilization residuals 醫療器材生物性評估－第７部：環氧乙烷滅菌之殘留物 |
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CNS 14393-13
2018 Edition Biological evaluation of Medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices 醫療器材生物性評估－第１３部：聚合物醫療器材降解產物之鑑別及定量 |
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CNS 14393-5
2018 Edition Biological evaluation of Medical devices – Part 5：Tests for in vitro cytotoxicity 醫療器材生物性評估 －第五部分：體外細胞毒性試驗 |
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CNS 14989
2018 Edition Medical devices - Application of risk management to medical devices 醫療器材風險管理 |
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CNS 15153
2018 Edition Biological evaluation of medicaldevices - Part 17 : Establishment of allowable limits for leachable substances 醫療器材生物性評估－第１７部：可溶出物質容忍限量之建立 |
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CNS 14393-9
2018 Edition 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：潛在降解產物之鑑別及定量分析架構 |
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CNS 14990
2018 Edition Medical devices - Symbols to be used with medical device labels,labelling and information to be supplied 醫療器材－用於醫療器材標識、標示與資訊之符號 |
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CNS 14393-6
2018 Edition Biological evaluation of Medical devices - Part 6：Tests for local effects after implantation 醫療器材生物性評估－第六部分:植入後的局部效應測試 |
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CNS 14393-2
2018 Edition 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 |
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CNS 14393-8
2018 Edition 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 |
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CNS 14393-12
2018 Edition Biological evaluation of Medical devices - Part 12: Sample preparation and reference materials 醫療器材生物性評估－第１２部：樣品製備及參考材料 |
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CNS 14393-4
2018 Edition Biological evaluation of Medical devices – Part 4：Selection of tests for interactions with blood 醫療器材生物性評估－第四部分：血液接觸特性測試方法的選擇 |
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CNS 15006
2018 Edition Flow-metering devices for connection to terminal units of medical gas pipeline systems 連接於醫療氣體管線系統終端單元之流量計裝置 |
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CNS 15155
2018 Edition Biological evaluation of Medical devices - Part 19 : Physico-chemical, morphological and topographical characterization of materials 醫療器材生物性評估－第１９部：材料之物理化學、形態及拓撲學的特性分析 |
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CNS 14393-3
2018 Edition Biological evaluation of Medical devices – Part 3：Tests for genotoxicity, carcinogenicity and reproductive toxicity 醫療器材生物性評估－第三部分：基因毒性、致癌性與生殖毒性之試驗 |
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CNS 14991
2018 Edition Nomenclature - Specification for a nomenclature system for Medical devices for the purpose of regulatory data exchange 命名－用於醫療器材法規管理資料交換之命名系統的規格 |
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CNS 15154
2018 Edition Biological evaluation of Medical devices - Part 18 : Chemical characterization of materials 醫療器材生物性評估－第１８部：材料之化學特性 |
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CNS 14393-16
2018 Edition Biological evaluation of Medical devices - Part 16: Toxicokinetic study design for degradation products and leachables 醫療器材生物性評估－ 第１６部：降解產物與可溶出物毒性動力學之研究設計 |
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CNS 14393-15
2018 Edition 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鑑別及定量 |
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CNS 14393-14
2018 Edition Biological evaluation of Medical devices - Part 14: Identification and quantification of degradation products from ceramics 醫療器材生物性評估－第１４部：陶瓷降解產物之鑑別及定量 |
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CNS 14393-10
2018 Edition Biological evaluation of Medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity 醫療器材生物性評估－第１０部：刺激性及延遲型過敏性測試 |
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CNS 14393-11
2018 Edition Biological evaluation of Medical devices - Part 11: Tests for systemic toxicity 醫療器材生物性評估－第１１部：全身毒性測試 |
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