I.S. EN ISO 10993-1:2020
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-11)
Hardcopy , PDF
21-04-2021
English
06-01-2021
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.
Dates of withdrawal of national standards are available from NSAI.
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 |
CEN/TC 206
|
DocumentType |
Standard
|
Pages |
58
|
ProductNote |
This standard is also refer as ISO/TR 10993-19 The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
PublisherName |
National Standards Authority of Ireland
|
Status |
Superseded
|
SupersededBy | |
Supersedes |
Standards | Relationship |
ISO 10993-1:2018 | Identical |
EN ISO 10993-1:2020 | Identical |
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