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MS ISO 10993-4:2010 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, AMD. 1:2006, IDT)

MS ISO 10993-4:2010 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, AMD. 1:2006, IDT)
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This Malaysian Standard provides general requirements for evaluating the interactions of medical devices with blood. It describes: a) a classification of medical and dental devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in MS ISO 10993-1; b) the fundamental principles governing the evaluation of the interaction of devices with blood; c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests. Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for interactions of devices with blood. This standard describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.
Primary Item Type:
Malaysian Standard
Identifiers:
ICS 11.100.20
ISC ISC R - Medical Devices and Facilities for Healthcare
Standard Number MS ISO 10993-4:2010
Language:
English
Subject Keywords:
Medical devices; Biological evaluation; Tests
First presented to the public:
7/30/2018
Original Publication Date:
8/6/2015
Previously Published By:
Department of Standards Malaysia
Place Of Publication:
Cyberjaya, Selangor
Citation:
Extents:
Number of Pages - 49
License Grantor / Date Granted:
  / ( View License )
Date Deposited
2018-07-30 13:58:36.739
Date Last Updated
2019-01-07 11:24:16.6254
Submitter:
Mohamed Yunus Yusof

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MS ISO 10993-4:2010 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, AMD. 1:2006, IDT)1 2018-07-30 13:58:36.739
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