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  • PREN ISO 11197 : DRAFT 2012

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    MEDICAL SUPPLY UNITS (ISO/DIS 11197:2012)

    Available format(s): 

    Superseded date:  01-03-2016

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    Introduction
    1 Scope
    Annex AA (informative) - Rationale
    Annex BB (Informative) - Tests during production
    Annex CC (informative) - Documentation
    Bibliography
    Index of defined terms used in this particular standard
    Annex ZA (informative) - Relationship between this
             International Standard and the Essential
             Requirements of EU Directive 93/42/EEC

    Abstract - (Show below) - (Hide below)

    Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS, hereafter also referred to as ME EQUIPMENT.

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

    Comment Closes On
    Committee TC 215
    Document Type Draft
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

    National Adoptions - (Show below) - (Hide below)

    Equivalent Standard(s) Relationship
    12/30262133 DC : 0 Identical

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

    EN 60446:2007 Basic and safety principles for man-machine interface, marking and identification - Identification of conductors by colours or alphanumerics
    IEC 60364-5-54:2011 Low-voltage electrical installations - Part 5-54: Selection and erection of electrical equipment - Earthing arrangements and protective conductors
    ISO 3744:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
    IEC 60364-7-710:2002 Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations
    EN 50174-1:2009/A2:2014 INFORMATION TECHNOLOGY - CABLING INSTALLATION - PART 1: INSTALLATION SPECIFICATION AND QUALITY ASSURANCE
    ISO 9170-2:2008 Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas scavenging systems
    IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
    ISO 7396-2:2007 Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems
    ISO 32:1977 Gas cylinders for medical use — Marking for identification of content
    ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    EN 50174-2 : 2009 AMD 2 2014 INFORMATION TECHNOLOGY - CABLING INSTALLATION - PART 2: INSTALLATION PLANNING AND PRACTICES INSIDE BUILDINGS
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    IEC 60601-1-3:2008+AMD1:2013 CSV Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
    IEC 60598-1:2014+AMD1:2017 CSV Luminaires - Part 1: General requirements and tests
    IEC 60669-1:2017 Switches for household and similar fixed-electrical installations - Part 1: General requirements
    EN 61140:2016 Protection against electric shock - Common aspects for installation and equipment
    IEC 61386-1:2008+AMD1:2017 CSV Conduit systems for cable management - Part 1: General requirements
    ISO 9170-1:2017 Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN 13348:2016 Copper and copper alloys - Seamless, round copper tubes for medical gases or vacuum
    IEC 61950:2007 Cable management systems - Specifications for conduit fittings and accessories for cable installations for extra heavy duty electrical steel conduit
    IEC 60601-1-9:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
    ISO 7396-1:2016 Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum
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