UNI EN ISO 10993-18:2023
Current
Current
The latest, up-to-date edition.
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor
Published date
28-09-2023
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This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents.
| Committee |
CT 44
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 10993-18:2020 | Identical |
| ISO 10993-18:2020/Amd 1:2022 | Identical |
| ISO 10993-18:2020 | Identical |
| EN ISO 10993-18:2020/A1:2023 | Identical |
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