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ISO 10993-9:2009 PDF

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

First page of standard ISO 10993-9:2009Open preview (PDF)Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
Title (English):
ISO 10993-9:2009

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

Document status:
Withdrawn
Format:
Electronic (PDF)
Number of pages:
9
Publication date:
November 30, 2009
Edition:
ISO IS 10993 edition 2 version 1
ICS:
11.100.20
Description (English):

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.

Technical details

Technical committee
ISO/TC 194 - Biological and clinical evaluation of medical devices
SKU
ISO 10993-9:2009

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