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ISO/TR 15499:2016

Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process

Publication date:   Dec 13, 2016

95.99   Withdrawal of Standard   Oct 22, 2018

General information

95.99   Withdrawal of Standard   Oct 22, 2018

ISO

ISO/TC 194 Biological and clinical evaluation of medical devices

Technical Report

11.100.20   Biological evaluation of medical devices

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Scope

ISO/TR 15499:2016 is applicable to the conduct of biological evaluation of medical devices according to the requirements of ISO 10993‑1. It does not add to, or otherwise change, the requirements of ISO 10993‑1. This document does not include requirements to be used as the basis of regulatory inspection or certification assessment activities.
This guidance is applicable to all biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO/TR 15499:2012

NOW

WITHDRAWN
ISO/TR 15499:2016
95.99 Withdrawal of Standard
Oct 22, 2018