• I.S. EN 60601-2- 44:2009&A11:2011&A1:2012&A2:2016

    Current The latest, up-to-date edition.

    Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (IEC 60601-2-44:2009/A2:2016)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  21-06-2016

    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
    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
    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
    203 General requirements for RADIATION protection in diagnostic X-ray equipment
    Annexes
    Annex AA (informative) Choosing LOADING FACTORS for tests
    Annex BB (informative) Estimating CTDIvol for scan projection RADIOGRAPHY (SPR)
    Bibliography

    Abstract - (Show below) - (Hide below)

    This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of CT SCANNERS, hereafter also referred to as ME EQUIPMENT.

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

    Committee TC 62/SC 62B
    Document Type Standard
    Product Note The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. THIS STANDARD IS ALSO REFERS TO IEC TR 60513
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes
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