EN ISO 10993-9:2009

Name: EN ISO 10993-9:2009
Brand: CEN
SKU: EN ISO 10993-9:2009
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Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009) EN ISO 10993-9:2009

Publication date: Aug 20, 2010

General information

Current stage: 99.60 Withdrawal effective Sep 29, 2021

Originator: CEN

Owner: CEN/TC 206 Biological and clinical evaluation of medical devices

Type: European Norm

ICS: 11.100.20 Biological evaluation of medical devices

Buying

Status: Withdrawn

Scope

ISO 10993-9:2008 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. ISO 10993-9:2008 considers both non-resorbable and resorbable materials.

Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Harmonized/Supporting

93/42/EEC

Medical devices

Harmonized/Supporting

2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

PREVIOUSLY

WITHDRAWN
EN ISO 10993-9:2009

NOW

WITHDRAWN
EN ISO 10993-9:2009
99.60 Withdrawal effective
Sep 29, 2021

REVISED BY

PUBLISHED
EN ISO 10993-9:2021