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DS EN ISO 10993-4:2009被替代

Biological Evaluation Of Medical Devices - Part 4: Selection Of Tests For Interactions With Blood

出版:Danish Standards

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基本信息
标准编号: DS EN ISO 10993-4:2009
发布时间:2009/7/2 0:00:00
标准类别:Standard
出版单位:Danish Standards
标准页数:64
标准简介

Gives general requirements for evaluating the interactions of medical devices with blood. It also explains: 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 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.

替代本标准的新标准

DS EN ISO 10993-4:2017

等同采用的国际标准

EN ISO 10993-4:2009 - Identical