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ISO TR 37137 : 2014

M00029712

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ISO TR 37137 : 2014

CARDIOVASCULAR BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE FOR ABSORBABLE IMPLANTS

International Organization for Standardization

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Table of Contents

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

Abstract

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.

General Product Information

Document Type Standard
Status Current
Publisher International Organization for Standardization
Committee TC 194