DS/EN ISO 10993-1:2025
Current
Current
The latest, up-to-date edition.
Biological evaluation of medical devices – Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025)
Published date
05-01-2026
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This document specifies the requirements and general principles governing the biological evaluation of medical devices within a risk management process according to ISO 14971.
| Committee |
DS/S-258
|
| DocumentType |
Standard
|
| PublisherName |
Danish Standards
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO/FDIS 10993-1 | Identical |
| EN ISO 10993-1:2025 | Identical |
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