AS ISO 10993.9:2002

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Biological evaluation of medical devices – Framework for identification and quantification of potential degradation products

Published By	Publication Date	Number of Pages
AS	2002-06-28	16

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Categories: 11.040.01 - Medical equipment in general, 11.060.01 - Dentistry in general, 11.100.20 - Biological evaluation of medical devices, AS

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Description

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.

Scope

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 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.

Additional information

Published Code	AS
Published By	Australia Standards
Publication Date	2002-06-28
Pages Count	16
Language	English
Edition	1
File Size	102.4 KB
ISBN	0733746977
ICS Codes	11.040.01 - Medical equipment in general 11.060.01 - Dentistry in general 11.100.20 - Biological evaluation of medical devices

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AS ISO 10993.9:2002

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