ISO-15499 › Historical Revision Information
Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
Document Center Inc. is an authorized dealer of ISO standards.
The following bibliographic material is provided to assist you with your purchasing decision:
The following bibliographic material is provided to assist you with your purchasing decision:
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.
To find similar documents by classification:
11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Document Number
ISO/TR 15499:2016
Revision Level
2ND EDITION
Status
Superseded
Publication Date
Dec. 15, 2016
Committee Number
ISO/TC 194