UNE-EN ISO 10993-9:2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 (ISO 10993-9:2009)
Hardcopy , PDF
25-05-2022
Spanish, Castilian, English
09-06-2010
1 Scope
2 Normative references
3 Terms and definitions
4 Principles for design of degradation studies
4.1 General
4.2 Preliminary considerations
4.3 Study design
4.4 Characterization of degradation products from
medical devices
5 Study report
Annex A (normative) Considerations of the need for
degradation studies
Annex B (informative) Biodegradation study considerations
Annex ZA (normative) Normative references to international
publications with their relevant
European publications
Bibliography
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