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BS EN ISO 10993-9:2021 – TC:2022 Edition

BS EN ISO 10993-9:2021 – TC:2022 Edition

$186.33

Tracked Changes. Biological evaluation of medical devices – Framework for identification and quantification of potential degradation products

Published By Publication Date Number of Pages
BSI 2022 54
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This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series.

This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade.

This document is not applicable to:

  1. the evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available;

    NOTE

    Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this document, such degradation products can evoke a biological response and can undergo biological evaluation as described in other parts of ISO 10993 .

  2. leachable components which are not degradation products;

  3. medical devices or components that do not contact the patient’s body directly or indirectly.

PDF Catalog

PDF Pages PDF Title
1 30455776
31 A-30354690
32 National foreword
36 European foreword
38 Annex ZA (informative) Relationship between this European Standard and the general health and safety requirements of Regulation (EU) 2017/745 on medical devices aimed to be covered
41 Foreword
42 Introduction
43 1 Scope
2 Normative references
3 Terms and definitions
44 4 Principles for design of degradation studies
4.1 General
45 4.2 Preliminary considerations
4.3 Study design
46 4.4 Characterization of degradation products from medical devices
5 Study report
48 Annex A (normative) Consideration of the need for degradation studies
50 Annex B (informative) Degradation study considerations
52 Bibliography

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BS EN ISO 10993-9:2021 - TC
$186.33