BAS EN ISO 10993-9:2010
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
General Information
Status: Withdrawn
No. of pages: 14
Language: English
Edition: 2.
Adoption method: Endorsment
Publication date: 25.06.2010
Technical committee:
Directive:
90/385/EEC, Active implantable medical devices
93/42/EEC, Medical devices;
93/42/EEC, Medical devices;
...
Abstract
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.
Lifecycle
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Original document and degree of correspondence
- EN ISO 10993-9:2009, identical
- ISO 10993-9:2009, identical