Standard

NEN-EN-ISO 10993-16:2008 Ontw. en

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

  • This norm is withdrawn since 23-02-2010

23,85 28,86 Incl BTW

About norm

Status Withdrawn
Number of pages 19
Committee Biocompatibiliteit en biologisch onderzoek
Published on 01-08-2008
Language English
This part of ISO 10993 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.

Details

ICS-code 11.100.20
Dutch title Biologische evaluatie van medische hulpmiddelen - Deel 16: Ontwerp voor toxikinetische studies voor degradatieproducten en uit het materiaal lekkende stoffen
English title Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
Replaces
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