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SSH EN ISO 10993-9:2000

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)

Jan 1, 2000
95.99 Withdrawal of Standard   Dec 30, 2009

General information

95.99     Dec 30, 2009

DPS

DPS/KT 316

European Norm

11.100  

English  

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Scope

This part of ISO 10993 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. This part of ISO 10993 is not applicable to: a) viable-tissue engineered products; b) methodologies for the generation of degradation products by mechanical processes. Methodologies for the production of this type of degradation product are described in specific product standards, where available; c) leachable components wich are not degradation products. Where product standards provide applicable product-specific methodologies for the identification and quantification of degradation products, those standards shall be considered as alternatives.

Related directives

Directives related to this standards.

90/385/EEC

Active implantable medical devices

Harmonized
93/42/EEC

Medical devices

Harmonized

Life cycle

PREVIOUSLY

PUBLISHED
SSH EN ISO 10993-9:2009

NOW

WITHDRAWN
SSH EN ISO 10993-9:2000
95.99 Withdrawal of Standard
Dec 30, 2009

Related project

Adopted from EN ISO 10993-9:1999