EN ISO 10993-9:2021

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)

Publication date:   Jan 20, 2022

General information

60.60 Standard published   Sep 29, 2021

CEN

CEN/TC 206 Biological and clinical evaluation of medical devices

European Norm

11.100.20   Biological evaluation of medical devices

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Scope

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:
a) 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.
b) leachable components which are not degradation products;
c) medical devices or components that do not contact the patient's body directly or indirectly.

Related legislation

Legislation related to this standard

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Harmonized/Supporting

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 10993-9:2009

NOW

PUBLISHED
EN ISO 10993-9:2021
60.60 Standard published
Sep 29, 2021