ISO-15499 › Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process

ISO-15499 - 2ND EDITION - SUPERSEDED
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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.

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11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)

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Document Number

ISO/TR 15499:2016

Revision Level

2ND EDITION

Status

Superseded

Publication Date

Dec. 15, 2016

Committee Number

ISO/TC 194