>ISO Standards>ISO/TR 15499:2016-Biological evaluation of medical devices-Guidance on the conduct of biological evaluation within a risk management process-Buythis standard
Not available online - contact us!
immediate downloadReleased: 2016
ISO/TR 15499:2016
Biological evaluation of medical devices
CURRENCY
Standard´s number:
ISO/TR 15499:2016
Pages:
15
Edition:
2
Released:
2016
Language:
English
DESCRIPTION
ISO/TR 15499:2016
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.