• CEI EN 60601-1-10/A2:2022

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    Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  04-01-2022

    Publisher:  Comitato Elettrotecnico Italiano

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    Abstract - (Show below) - (Hide below)

    This collateral standard specifies 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) to control at least one PATIENT VARIABLE (i.e. a PHYSIOLOGIC VARIABLE) in ME EQUIPMENT and ME SYSTEMS.

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    Document Type Amendment
    Publisher Comitato Elettrotecnico Italiano
    Status Current
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