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SSH EN ISO 10993-9:2009

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

Sep 26, 2012

General information

60.60     Sep 26, 2012

DPS

DPS/KT 316

European Norm

11.100.20  

English  

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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 directives

Directives related to this standards.

90/385/EEC

Active implantable medical devices

Harmonized
93/42/EEC

Medical devices

Harmonized
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

Life cycle

NOW

PUBLISHED
SSH EN ISO 10993-9:2009
60.60 Standard published
Sep 26, 2012

REVISED BY

WITHDRAWN
SSH EN ISO 10993-9:2000

PUBLISHED
SSH EN ISO 10993-9:2021

Related project

Adopted from EN ISO 10993-9:2009