I.S. EN 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 (ISO 10993-1:2025)
Hardcopy , PDF
English
08-01-2026
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.
Dates of withdrawal of national standards are available from NSAI.
European foreword
Annex ZA (informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
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 |
ISO/TC 194
|
| DocumentType |
Standard
|
| Pages |
42
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 10993-1:2025 | Identical |
| ISO 10993-1:2025 | Identical |
| ISO 22442-2:2020 | Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling |
| ISO 18562-1:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process |
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