SR EN ISO 10993-9:2010

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)

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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General information

Status : Withdrawn
Approval date : 5/31/2010
Publish date : 6/2/2010
Withdrawal date : 10/29/2021
Number of pages : 22
ICS : 11.100.20 Biological evaluation of medical devices
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN ISO 10993-9:2009
Replaced by SR EN ISO 10993-9:2021