• I.S. EN 60601-1-10:2008&A1:2015&A2:2021

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    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 (IEC 60601-1-10:2007/A2:2020)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  08-02-2021

    Publisher:  National Standards Authority of Ireland

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    Table of Contents - (Show below) - (Hide below)

    FOREWORD
    INTRODUCTION
    1 Scope, object and related standards
    2 Normative references
    3 Terms and definitions
    4 * General requirements
    5 ME EQUIPMENT identification, marking and documents
    6 Accuracy of controls and instruments and protection against hazardous outputs
    7 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
    8 Requirements for PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC) development
    Annex A (informative) General guidance and rationale
    Annex B (informative) Description of dynamic performance of a PCLCS
    Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS
    Bibliography

    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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    Committee ISO/TC 121/SC 3
    Document Type Standard
    Product Note The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes
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