DS EN 60601-2-19 : 2009 AMD 1 2016现行
MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS
出版：Danish Standards
专家解读视频
基本信息
标准编号： DS EN 60601-2-19 : 2009 AMD 1 2016
标准类别：Standard
出版单位：Danish Standards
标准页数：0
标准简介
Defines safety requirements for INFANT INCUBATORS but alternate methods of compliance with a specific clause by demonstrating equivalent safety will not be judged as non-compliant if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device.
