Withdrawn
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: a) viable-tissue engineered products; b) 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; c) leachable components wich 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.
Directives related to this standards.
PUBLISHED
SSH EN ISO 10993-9:2009
WITHDRAWN
SSH EN ISO 10993-9:2000
95.99
Withdrawal of Standard
Dec 30, 2009