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  • AS/NZS 3551:2012

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    Management programs for medical equipment

    Available format(s):  Hardcopy, PDF 1 User, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s): 

    Published date:  31-10-2012

    Publisher:  Standards Australia

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    Abstract - (Show below) - (Hide below)

    Specifies procedures required to develop equipment management programs for medical equipment. Includes procedures for procurement, acceptance, fault management, routine testing and disposal of medical equipment. Intended to cover all medical equipment, whether hospital property, privately owned, on loan or on trial, except for the commissioning requirements for permanently installed medical electrical equipment in cardiac and body-protected patient pre-treatment areas.

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

    Committee HE-003
    Document Type Standard
    Publisher Standards Australia
    Status Current
    Supersedes
    Under Revision

    History - (Show below) - (Hide below)

    Originated in Australia as AS 3551—1988.Jointly revised and designated as AS/NZS 3551:1998.Previous edition 2004.Fourth edition 2012. Originated in Australia as AS 3551-1988. Jointly revised and designated as AS/NZS 3551:1998. Previous edition 2004. Fourth edition 2012. Reissued incorporating Amendment No. 1 (October 2013). Reissued incorporating Amendment No. 2 (September 2016).

    Standards Referenced By This Book - (Show below) - (Hide below)

    AS ISO 13485-2003 Medical devices - Quality management systems - Requirements for regulatory purposes
    AS/NZS 3200.2.45:1999 Medical electrical equipment Particular requirements for safety - Mammographic X-ray equipment and mammographic stereotactic devices
    AS/NZS 3200.2.4:2006 Medical electrical equipment Particular requirements for safety - Cardiac defibrillators
    AS/NZS 60320.1:2012 Appliance couplers for household and similar general purposes General requirements (IEC 60320-1, Ed. 2.1 (2007) MOD)
    AS/NZS 3200.2.40:1999 Medical electrical equipment Particular requirements for safety - Electromyographs and evoked response equipment
    AS/NZS 3200.1.0-1998 Medical electrical equipment General requirements for safety - Parent Standard
    AS/NZS 3760:2010 In-service safety inspection and testing of electrical equipment
    AS/NZS 2500:2004 Guide to the safe use of electricity in patient care
    AS/NZS 3200.2.44:2005 Medical electrical equipment Particular requirements for safety - X-ray equipment for computed tomography
    AS/NZS 3200.2.43:2002 Medical electrical equipment Particular requirements for safety - X-ray equipment for interventional procedures (IEC 60601-2-43:2000, MOD)
    AS/NZS ISO 31000:2009 Risk management - Principles and guidelines
    AS/NZS 3200.2.46:2003 Medical electrical equipment Particular requirements for the safety of operating tables
    AS/NZS 3200.2.41:2002 Medical electrical equipment Particular requirements for safety - Surgical luminaires and luminaires for diagnosis (IEC 60601-2-41:2000, MOD)
    AS/NZS 3112:2011 Approval and test specification - Plugs and socket-outlets
    AS/NZS 4513:1995 Medical electrical equipment - Fundamental aspects of safety standards (Reconfirmed 2022)
    AS/NZS 60320.1:2004 Appliance couplers for household and similar general purposes General requirements (IEC 60320-1, Ed. 2.0 (2001) MOD)

    Standards Referencing This Book - (Show below) - (Hide below)

    AS/NZS 3003:2018 Electrical installations - Patient areas
    AS/NZS 4173:2018 Safe use of lasers and intense light sources in health care
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