I.S. EN ISO 10993-1:2020&LC:2021
Current
The latest, up-to-date edition.
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
Hardcopy , PDF
English
04-19-2021
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.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles applying to biological evaluation of medical devices
5 Categorization of medical devices
6 Biological evaluation process
7 Interpretation of biological evaluation data and overall biological risk assessment
Annex A (informative) Endpoints to be addressed in a biological risk assessment
Annex B (informative) Guidance on the conduct of biological evaluation within a risk management process
Annex C (informative) Suggested procedure for literature review
Bibliography
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