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
Chinese Version Price	$***.00 USD
English Version	Translate after your order
English Translation Price	$.00* USD
Translation Time	About 5 Work Days


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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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