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Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
English, French
13-12-2016
16-07-2021
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.
| Committee |
ISO/TC 194
|
| DocumentType |
Technical Report
|
| Pages |
15
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| Supersedes |
| Standards | Relationship |
| PD ISO/TR 15499:2016 | Identical |
| FD ISO/TR 15499 : 2013 FD | Identical |
| NEN NPR ISO/TR 15499 : 2017 | Identical |
| AAMI/ISO TIR15499:2017 | Identical |
This standard has been withdrawn and is no longer current. No replacement edition is available.
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