Part 1-10: General requirements for basic safety and essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers
(IEC 60601-1-10:2007); German version EN 60601-1-10:2008 Class/Status:
VDE Art. No.: 0750139
This International Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems. This collateral standard specifies requirements for the development (analysis, design, verification and validation) of a physiologic closed-loop controller as part of a physiologic closed-loop control system (PCLCS) in medical electrical equipment and medical electrical systems to control a phyiologic variable. It amends DIN EN 60601-1 (VDE 0750-1)2007-07.
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