Medical electrical equipment, Part 1.11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Published by	Publication Date	Number of Pages
AS	06/23/2017		52

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Category: AS

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AS IEC 60601.1.11 – Medical electrical equipment, Part 1.11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

The objective of this Standard is to specify 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 medical electrical (ME) equipment and ME systems to control a physiologic variable.