I.S. EN ISO 10993-9:2021
Current
The latest, up-to-date edition.
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
Hardcopy , PDF
English
18-10-2021
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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principles for design of degradation studies
5 Study report
Annex A (normative) Consideration of the need for degradation studies
Annex B (informative) Degradation study considerations
Bibliography
This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation studies.
| Committee |
ISO/TC 194
|
| DocumentType |
Standard
|
| Pages |
30
|
| ProductNote |
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 |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 10993-9:2021 | Identical |
| ISO 10993-9:2019 | Identical |
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