Reference number
ISO/TR 15499:2016
© ISO 2024
Technical Report
ISO/TR 15499:2016
Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process
Edition 2
2016-12
Withdrawn
Withdrawn (Edition 2, 2016)

Abstract

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.

General information

  • Status
     : Withdrawn
    Publication date
     : 2016-12
    Stage
    : Withdrawal of International Standard [95.99]
  • Edition
     : 2
    Number of pages
     : 15
  • Technical Committee :
    ISO/TC 194
    ICS :
    11.100.20 
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