EN ISO 10993-9:1999

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

Publication date:   Oct 23, 2003

General information

99.60 Withdrawal effective   May 20, 2009

CEN

CEN/TC 206 Biological and clinical evaluation of medical devices

European Norm

11.100   Laboratory medicine

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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 legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Harmonized/Supporting
93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

NOW

WITHDRAWN
EN ISO 10993-9:1999
99.60 Withdrawal effective
May 20, 2009

REVISED BY

WITHDRAWN
EN ISO 10993-9:2009