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MS ISO 10993-9:2013 - Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009, IDT)

MS ISO 10993-9:2013 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009, IDT)
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This Malaysian Standard 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 MS ISO 10993 series. This standard considers both non-resorbable and resorbable materials. This standard is not applicable to: a) evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available; b) leachable components which are not degradation products; c) medical devices or components that do not contact the patient's body directly or indirectly.
Primary Item Type:
Malaysian Standard
Identifiers:
Standard Number MS ISO 10993-9:2013
ICS 11.100.20
ISC ISC R - Medical Devices and Facilities for Healthcare
Language:
English
Subject Keywords:
Medical devices; Biological evaluation; Framework; Identification; Quantification
First presented to the public:
9/6/2018
Original Publication Date:
6/4/2013
Previously Published By:
Department of Standards Malaysia
Place Of Publication:
Cyberjaya, Selangor
Citation:
Extents:
Number of Pages - 19
License Grantor / Date Granted:
  / ( View License )
Date Deposited
2018-09-06 14:59:19.814
Date Last Updated
2022-03-10 10:16:03.047
Submitter:
Mohamed Yunus Yusof

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MS ISO 10993-9:2013 - Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009, IDT)1 2018-09-06 14:59:19.814
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