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ISO 10993-9:1999

Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products

Pages: 8
Publication date: 1999-03-01
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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:viable-tissue engineered products;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;leachable components which 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.
Document identifier
ISO 10993-9:1999
Title
Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products
ISO Category
TC 194/WG 2: Degradation aspects related to biological testing
Publication date
1999-03-01
Status
Ineffective
International Relationship
Cross references
Latest version
ISO 10993-9:2009
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
Document identifier ISO 10993-9:2009
Publication date 2009-12-15
Classification 11.100.20. Biological evaluation of medical devices, Medical microbiology, see 07.100.10
Status Effective
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History of version
ISO 10993-9:2009*ISO 10993-9:1999 * ISO 10993-9:2009 * ISO 10993-9:1999
Keywords
Pages
8
Price Contact