ISO/TR 15499:2016 PDF
Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process
Open preview (PDF)Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management processBiological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process
- Document status:
- Withdrawn
- Format:
- Electronic (PDF)
- Number of pages:
- 15
- Publication date:
- December 13, 2016
- Edition:
- ISO TR 15499 edition 2 version 1
- ICS:
- 11.100.20
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.
Technical details
- Technical committee
- ISO/TC 194 - Biological and clinical evaluation of medical devices
- SKU
- ISO/TR 15499:2016
