NEN EN IEC 60601-1-10:2008現行
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
專家解讀視頻
基本信息
標準編號： NEN EN IEC 60601-1-10:2008
發布時間：2008/6/1 0:00:00
標準類別：Standard
出版單位：Nederlands Normalisatie Instituut
標準頁數：79
標準簡介
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.
