I.S. EN ISO 10993-1:2020&LC:2021

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

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.