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I.S. EN 60601-1-6:2010现行

Medical Electrical Equipment Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability

出版:National Standards Authority of Ireland

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基本信息
标准编号: I.S. EN 60601-1-6:2010
发布时间:2010/5/4 0:00:00
标准类别:Standard
出版单位:National Standards Authority of Ireland
标准页数:84
标准简介

Describes a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT.