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I.S. EN ISO 10993-9:2009 (APRIL 2010)

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
Available format(s)

Hardcopy , PDF

Superseded date

10-21-2021

Language(s)

English

Published date

05-13-2010

Preview

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) 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Superseded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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