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.
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
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