Codes & Standards - Subscribe
CAN/CSA-ISO 10993-9-00
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)
SKU: 2701019
Published by CSA Group
Publication Year 2000
Withdrawn
Product Details
Scope
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.
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.
items 1 - 1 of 1 result(s)
View 20 | View 100
CAN/CSA-ISO 10993-9-00
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)
Withdrawn
English
CAN/CSA-ISO 10993-9-F00
Évaluation biologique des dispositifs médicaux - Partie 9: Cadre pour l'identification et la quantification des produits potentiels de dégradation (norme ISO 10993-9:1999 adoptée, première édition, 1999-03-01)
Withdrawn
French
CAN/CSA-ISO 10993.9-98
Biological evaluation of medical devices -- Part 9: Degradation of materials rel ated to biological testing (Adopted ISO/TR 10993-9:1994, first edition)
Withdrawn
English