DS/EN 30993-4:1994
医疗器械的生物学评估．第4部分：与血相合试验的选择

Biological evaluation of medical devices. Part 4: Selection of tests for interactions with blood

作废

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标准号

DS/EN 30993-4:1994

发布

1994年

发布单位

丹麦标准化协会

当前最新

DS/EN 30993-4:1994

 

 

适用范围

This part of ISO 10993 gives guidance to agencies, manufacturers, research laboratories and others 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 ISO 10993-1; b) the fundamental principles governing the evalu-ation of the interaction of devices with blood; c) the rationale for structured selection of tests, to-gether with the principles and scientific basis of these tests. Detailed requirements for testing cannot be specified because of the limitations in knowledge and precision of tests for interactions of devices with blood.

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