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Biological Evaluation of Medical Devices - Part 9: Framework for Identification and Quantification of Potential Degradation Products (Adopted ISO 10993-9:1999, first edition, 1999-03-01)
Publication Year 2000
Published by CSA Group
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Pages: 7
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SKU: 2413210
This document is purchased as a PDF (Portable Document Format) and accessed via CSA OnDemand™, where you can view, navigate, and print it, or download it for offline use with Adobe Acrobat Viewer. This PDF contains Digital Rights Management protection and is intended for individual use. Please see Terms of Use for CSA’s copyright license and more information.
This part of ISO 10993 provides general principles for the systematic evaluation of the potential and observed biode gradation 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 degrad ation products, those standards shall be considered as alternatives.
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