SS-EN-ISO-10993-16 › Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
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ISO 10993-16:2017 provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.
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11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)
Active implantable medical devices. Medical devices. Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
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Designation Name
SS-EN ISO 10993-16:2017
Revision Level
2017 EDITION
Status
Current
Publication Date
Dec. 13, 2017
Language(s)
English
Page Count
23
International Equivalent
EN ISO 10993-16:2017(IDT); ISO 10993-16:2017(IDT)