I.S. EN ISO 10993-12:2021&A1:2025
Current
The latest, up-to-date edition.
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Amendment 1 (ISO 10993 12:2021/Amd 1:2025)
Hardcopy , PDF
English
25-09-2025
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series.
| Committee |
ISO/TC 194
|
| DocumentType |
Standard
|
| Pages |
52
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 10993-12:2021/Amd 1:2025 | Identical |
| EN ISO 10993-12:2021/A1:2025 | Identical |
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