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BSI PD ISO/TR 15499:2016

Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
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BSI PD ISO/TR 15499:2016

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

PUBLISH DATE 2017
PAGES 26
BSI PD ISO/TR 15499:2016

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
  • non-implantable medical devices
SDO BSI: British Standards Institution
Document Number ISO/TR 15499
Publication Date Jan. 31, 2017
Language en - English
Page Count
Revision Level
Supercedes
Committee CH/194
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