I.S. EN ISO 10993-9:2009 (APRIL 2010)
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
Hardcopy , PDF
21-10-2021
English
13-05-2010
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.
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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) Biodegradation study considerations
Bibliography
This part of ISO 10993 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies.
| Committee |
TC 194
|
| DocumentType |
Standard
|
| Pages |
26
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 10993-9:2009 | Identical |
| EN ISO 10993-9:2009 | Identical |
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