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EN 60601-2-21 : 2009 AMD 1 2016現行

MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS (IEC 60601-2-21:2009/A1:2016)

出版:European Committee for Standards - Electrical

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基本信息
標準編號: EN 60601-2-21 : 2009 AMD 1 2016
標準類別:Standard
出版單位:European Committee for Standards - Electrical
標準頁數:0
標準簡介

Describes the safety requirements for INFANT RADIANT WARMERS, 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.