
Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process
出版:Danish Standards

专家解读视频
基本信息
标准编号: DS EN ISO 10993-1:2009
发布时间:2009/11/13 0:00:00
标准类别:Standard
出版单位:Danish Standards
标准页数:40
标准简介
Explains the general principles governing the biological evaluation of medical devices within a risk management framework and the general categorization of devices based on the nature and duration of their contact with the body.
等同采用的国际标准
EN ISO 10993-1:2009 - Identical