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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.100 Laboratory medicine>11.100.20 Biological evaluation of medical devices>BS EN ISO 10993-16:2017 Biological evaluation of medical devices Toxicokinetic study design for degradation products and leachables
immediate downloadReleased: 2020-03-30
BS EN ISO 10993-16:2017 Biological evaluation of medical devices Toxicokinetic study design for degradation products and leachables

BS EN ISO 10993-16:2017

Biological evaluation of medical devices Toxicokinetic study design for degradation products and leachables

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Standard number:BS EN ISO 10993-16:2017
Pages:28
Released:2020-03-30
ISBN:978 0 539 13460 5
Status:Standard
DESCRIPTION

BS EN ISO 10993-16:2017


This standard BS EN ISO 10993-16:2017 Biological evaluation of medical devices is classified in these ICS categories:
  • 11.100.20 Biological evaluation of medical devices

This document 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.