81st Edition, November 30, 1981
Evaluation of medical devices for biological hazards Part 4: Method of test for intracutaneous reactivity of extracts from medical devices
Includes all amendments and changes through Reaffirmation Notice , April 15, 1994
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Description / Abstract:
Describes the method of test designed to assess the localized reaction of tissue to leachable inherent or extraneous substances present in or on a medical device. Use with the guidance of Part 1.