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Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)

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Hardcopy , PDF

Language(s)

English

Published date

19-04-2021

Publisher

National Standards Authority of Ireland

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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.

Committee	TC 194
DocumentType	Standard
Pages	60
ProductNote	The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. THIS STANDARD ALSO REFERS TO ISO/TR 10993-19
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN ISO 10993-1:2020

Standards	Relationship
EN ISO 10993-1:2020	Identical
ISO 10993-1:2018	Identical

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

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)

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