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    I.S. EN IEC 80601-2-77:2021

    Current The latest, up-to-date edition.

    Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  18-10-2021

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    FOREWORD
    INTRODUCTION
    201.1 Scope, object and related standards
    201.2 Normative references
    201.3 Terms and definitions
    201.4 General requirements
    201.5 General requirements for testing of ME EQUIPMENT
    201.6 Classification of ME EQUIPMENT and ME SYSTEMS
    201.7 ME EQUIPMENT identification, marking and documents
    201.8 Protection against electrical HAZARDS from ME EQUIPMENT
    201.9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
    201.10 Protection against unwanted and excessive radiation HAZARDS
    201.11 Protection against excessive temperatures and other HAZARDS
    201.12 Accuracy of controls and instruments and protection against hazardous outputs
    201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT
    201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
    201.15 Construction of ME EQUIPMENT
    201.16 * ME SYSTEMS
    201.17 * ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS
    202 ELECTROMAGNETIC DISTURBANCES – Requirements and tests
    206 * USABILITY
    Annexes
    Annex D (informative) Symbols on marking
    Annex AA (informative) Particular guidance and rationale
    Annex BB (informative) Equations for the calculation of the overall system stopping performance and minimum distances
    Annex CC (informative) Stopping functions of the RASE
    Annex DD (informative) Alternative method to demonstrate structural integrity throughout the EXPECTED SERVICE LIFE of the RASE
    Annex EE (informative) Example of a testing method of the IMMUNITY test for HF SURGICAL EQUIPMENT emissions
    Bibliography

    Abstract - (Show below) - (Hide below)

    This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), hereafter referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and INTERFACE CONDITIONS.

    General Product Information - (Show below) - (Hide below)

    Committee SC 62D
    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
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