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     : Withdrawn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
  • Edition
     : 2
    Number of pages
     : 15
  • Technical Committee
     : ISO/TC 194 Biological and clinical evaluation of medical devices
  • ICS
     :
    11.100.20 Biological evaluation of medical devices

Life cycle

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