M00029712
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CARDIOVASCULAR BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE FOR ABSORBABLE IMPLANTS
International Organization for Standardization
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Availability date: 11/05/2021
Foreword
1 Scope
2 Terms and definitions
3 General considerations
4 Sterilization considerations
5 Drug-device combination product considerations
6 Part listing and description of absorbable related
issues in addition to the relevant parts of
ISO 10993 series 'Biological evaluation
of medical devices'
Annex A (informative) - Nomenclature of absorb,
degrade and related terms
Bibliography
Gives interim Part-by-Part guidance on potential adjustments to various test methods within the 10993 series to account for the intentional release of soluble components or degradation products from absorbable medical devices.
Published | |
Document Type | Standard |
Status | Current |
Publisher | International Organization for Standardization |
Pages | |
ISBN | |
Committee | TC 194 |