ISO/TR 15499:2016
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Biological evaluation of medical devices Guidance on the conduct of biological evaluation within a risk management process
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
16-07-2021
English, French
13-12-2016
ISO/TR 15499:2016 is applicable to the conduct of biological evaluation of medical devices according to the requirements of ISO 109931. It does not add to, or otherwise change, the requirements of ISO 109931. 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.
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