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SN EN ISO 10993-9 : 2010

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS
Withdrawn date

10-01-2021

Published date

01-12-2013

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

Gives general principles of systematic evaluating of the potential and observed biodegradation of medical devices and for designing and performing biodegradation studies.

DevelopmentNote
Supersedes SN 119800. (06/2006)
DocumentType
Standard
PublisherName
Swiss Standards
Status
Withdrawn
SupersededBy
Supersedes

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