DS EN 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：Danish Standards
专家解读视频
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.
EN 60601-1-10:2008 - Identical
