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"Biological Evaluation" CNS Standards List

T-Medical Equipments & Appliances
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
T-Medical Equipments & Appliances
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
T-Medical Equipments & Appliances
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
T-Medical Equipments & Appliances
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
T-Medical Equipments & Appliances
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
T-Medical Equipments & Appliances
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
T-Medical Equipments & Appliances
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
T-Medical Equipments & Appliances
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
T-Medical Equipments & Appliances
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
T-Medical Equipments & Appliances
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
T-Medical Equipments & Appliances
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
T-Medical Equipments & Appliances
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
T-Medical Equipments & Appliances
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
T-Medical Equipments & Appliances
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
T-Medical Equipments & Appliances
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
T-Medical Equipments & Appliances
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
T-Medical Equipments & Appliances
CNS 13643    2018 Edition
Biological Evaluation of Dental Materials
牙科材料之生物評估
T-Medical Equipments & Appliances
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
T-Medical Equipments & Appliances
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
T-Medical Equipments & Appliances
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
T-Medical Equipments & Appliances
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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