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ISO - TR 15499

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

active, Most Current
Organization: ISO
Publication Date: 1 December 2016
Status: active
Page Count: 22
ICS Code (Biological evaluation of medical devices): 11.100.20
scope:

This document 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.

Document History

TR 15499
December 1, 2016
Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
This document 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...
July 15, 2012
Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
This Technical Report 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...

References

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