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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING
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Available format(s): Hardcopy, PDF
Withdrawn date: 28-02-2006
Language(s): English
Published date: 31-12-2000
Publisher: Canadian Standards Association
1 Scope2 Definitions3 General principles applying to biological evaluation of medical devices4 Categorization of medical devices5 Testing6 Selection of biological evaluation test7 Assurance of test methodsAnnexes A RationaleB Flow chart to aid in systematic approach to biological evaluation of medical devicesC Bibliography
Specifies general principles governing the biological evaluation of medical devices, categorization of devices based on the nature and duration of their contact with the body and the selection of appropriate tests.
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