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UNE-EN ISO 10993-16:2018

Current

Current

The latest, up-to-date edition.

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

16-05-2018

€87.60
Excluding VAT

This part of ISO 10993 gives principles on how toxicokinetic studies relevant to medical devices should bedesigned and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in thebiological evaluation of medical devices.

Committee
CTN 111
DocumentType
Standard
Pages
27
PublisherName
Asociación Española de Normalización
Status
Current

Standards Relationship
EN ISO 10993-16:2017 Identical
ISO 10993-16:2017 Identical

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€87.60
Excluding VAT