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CNS 14393-16 Standard english version summary

 
CNS Chinese National Standard General No. CNS14393-16
Classified No. T5013-16
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
Date of Approval
Bureau of Standards, Metrology and Inspection Date of Revision
 
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CNS Standard Code CNS 14393-16
CNS Standard English Title Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
CNS Standard Chinese Title 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
CNS Standard Classified No. T5013-16 - Medical Equipments & Appliances
CNS Standard Status Status:Current; Latest date:06/01/2006 Confirmed date:12/10/2018
Chinese Version Pages 8
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  • Relational CNS standards of CNS 14393-16     Keyword: Biological evaluation medical devices 16: Toxicokinetic study design degradation ...
  • Standard  Code
  • Standard Title
  • CNS 14393-1:2018
  • Biological evaluation of medical devices – Part 1:Evaluation and testing
  • CNS 14393-7:2018
  • Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
  • CNS 14393-13:2018
  • Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
  • CNS 14393-5:2018
  • Biological evaluation of medical devices – Part 5:Tests for in vitro cytotoxicity
  • CNS 15153:2018
  • Biological evaluation of medicaldevices - Part 17 : Establishment of allowable limits for leachable substances
  • CNS 14393-9:2018
  • Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
  • CNS 14393-6:2018
  • Biological evaluation of medical devices - Part 6:Tests for local effects after implantation
  • CNS 14393-2:2018
  • Biological evaluation of medical devices — Part 2:Animal welfare requirements
  • CNS 14393-8:2018
  • Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests
  • CNS 14393-12:2018
  • Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
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