DS/ISO 10993-1:2025
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
05-01-2026
This document specifies: – the general principles governing the biological evaluation of medical devices within a risk management process; – the general categorization of medical devices based on the nature and duration of their contact with the body; – the evaluation of existing relevant data from all sources; – the identification of gaps in the available data set on the basis of a risk analysis; – the identification of additional data sets necessary to analyse the biological safety of the medical device; – the assessment of the biological safety of the medical device.
| Committee |
DS/S-258
|
| DocumentType |
Standard
|
| PublisherName |
Danish Standards
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 10993-1:2025 | Identical |
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