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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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.
Dates of withdrawal of national standards are available from NSAI.
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
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