NEN EN IEC 60601-1-10:2008现行
Medical Electrical Equipment - Part 1-10: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For The Development Of Physiologic Closed-Loop Controllers
出版：Nederlands Normalisatie Instituut
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基本信息
标准编号： NEN EN IEC 60601-1-10:2008
发布时间：2008/6/1 0:00:00
标准类别：Standard
出版单位：Nederlands Normalisatie Instituut
标准页数：79
标准简介
Defines requirements for the development (analysis, design, VERIFICATION and VALIDATION) of a PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC) as part of a PHYSIOLOGIC CLOSED-LOOP CONTROL SYSTEM (PCLCS) in ME EQUIPMENT and ME SYSTEMS to control a PHYSIOLOGIC VARIABLE. Applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.
