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

ISO-10993-9 - 2ND EDITION - CURRENT
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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.

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11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)

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Document Number

ISO 10993-9:2009

Revision Level

2ND EDITION

Status

Current

Publication Date

Dec. 15, 2009

Committee Number

ISO/TC 194