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  • DIN EN ISO 7396-1:2016-09

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016)

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-05-2019

    Language(s):  German, English

    Published date:  01-01-2016

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    National foreword
    National Annex NA (informative) - Bibliography
    European foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Supply systems
    6 Monitoring and alarm systems
    7 Pipeline distribution systems
    8 Shut-off valves
    9 Terminal units, gas-specific connectors,
       medical supply units, pressure regulators
       and pressure gauges
    10 Marking and colour coding
    11 Pipeline installation
    12 Testing and commissioning
    13 Information to be supplied by the manufacturer
    Annex A (informative) - Schematic representations of typical
            supply systems and area distribution systems
    Annex B (informative) - Guidelines for location of cylinder
            manifolds, cylinder storage areas and stationary vessels
            for cryogenic or non-cryogenic liquids
    Annex C (informative) - Example of procedure for testing
            and commissioning
    Annex D (informative) - Typical forms for documenting compliance
            of the pipeline systems for compressed medical gas and
            vacuum
    Annex E (informative) - Temperature and pressure relationships
    Annex F (informative) - Risk management checklist
    Annex G (informative) - Operational management
    Annex H (informative) - Rationale
    Annex I (informative) - Rationale for compressor hazards
    Annex J (informative) - Considerations for implementation and
            use of oxygen 93
    Annex K (informative) - Manufacture of medical gases on site,
            Responsibility for medical gas quality
    Bibliography
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential
             Requirements of EU Directive 93/42/EEC
             on Medical devices

    Abstract - (Show below) - (Hide below)

    Defines requirements for design, installation, function, performance, testing, commissioning and documentation of pipeline systems used in healthcare facilities.

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

    Development Note Supersedes DIN EN 737-3. (07/2007) Supersedes DIN ISO 10083. (09/2016) DRAFT AMD 1 issued in April 2017. (04/2017)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By
    Supersedes

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

    DKI I 164 : 2017 KUPFERROHRE IN DER KAELTE-KLIMATECHNIK, FUER TECHNISCHE UND MEDIZINISCHE GASE
    DIN EN ISO 80601-2-72:2016-04 Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015)
    DIN EN ISO 15002:2008-11 FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS
    DIN EN ISO 80601-2-69:2014-12 Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)
    DIN EN ISO 5359:2015-02 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014)
    DIN EN ISO 7396-2:2007-07 Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)
    DIN EN ISO 10079-3:2014-09 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014)

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

    DIN EN ISO 18082:2014-10 ANAESTHETIC AND RESPIRATORY EQUIPMENT - DIMENSIONS OF NON-INTERCHANGEABLE SCREW-THREADED (NIST) LOW-PRESSURE CONNECTORS FOR MEDICAL GASES (ISO 18082:2014 + AMD. 1:2017)
    DIN EN ISO 80601-2-69:2014-12 Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)
    ISO 7183:2007 Compressed-air dryers Specifications and testing
    ISO 17672:2016 Brazing Filler metals
    DIN EN ISO 11197 : 2016 MEDICAL SUPPLY UNITS (ISO 11197:2016)
    DIN EN ISO 14644-1:2016-06 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 1: CLASSIFICATION OF AIR CLEANLINESS BY PARTICLE CONCENTRATION (ISO 14644-1:2015)
    ISO 8573-5:2001 Compressed air Part 5: Test methods for oil vapour and organic solvent content
    ISO 80601-2-69:2014 Medical electrical equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
    EN 1254-4:1998/AC:1999 COPPER AND COPPER ALLOYS - PLUMBING FITTINGS - PART 4: FITTINGS COMBINING OTHER END CONNECTIONS WITH CAPILLARY OR COMPRESSION ENDS
    ISO 11114-1:2012 Gas cylinders Compatibility of cylinder and valve materials with gas contents Part 1: Metallic materials
    DIN EN ISO 4126-1:2013-12 SAFETY DEVICES FOR PROTECTION AGAINST EXCESSIVE PRESSURE - PART 1: SAFETY VALVES (ISO 4126-1:2013 + AMD 1:2016)
    DIN EN ISO 11114-2:2013-07 Gas cylinders - Compatibility of cylinder and valve materials with gas contents - Part 2: Non-metallic materials (ISO 11114-2:2013); German version EN ISO 11114-2:2013
    Z7396.1-17 Medical gas pipeline systems - Part 1: Pipelines for medical gases, medical vacuum, medical support gases, and anaesthetic gas scavenging systems
    EN 12021:2014 RESPIRATORY EQUIPMENT - COMPRESSED GASES FOR BREATHING APPARATUS
    DIN EN ISO 13485:2016-08 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
    ISO 4126-1:2013 Safety devices for protection against excessive pressure Part 1: Safety valves
    CSA B51 : 2014 BOILER, PRESSURE VESSEL, AND PRESSURE PIPING CODE
    CGA P 8.1 : 2016 SAFE INSTALLATION AND OPERATION OF PSA AND MEMBRANE OXYGEN AND NITROGEN GENERATORS
    DIN EN ISO 5359:2015-02 ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014)
    ISO 10524-4:2008 Pressure regulators for use with medical gases Part 4: Low-pressure regulators
    EN 1254-1 : 1998 COPPER AND COPPER ALLOYS - PLUMBING FITTINGS - PART 1: FITTINGS WITH ENDS FOR CAPILLARY SOLDERING OR CAPILLARY BRAZING TO COPPER TUBES
    EN 475 : 1995 MEDICAL DEVICES - ELECTRICALLY GENERATED ALARM SIGNALS
    ISO 8359:1996 Oxygen concentrators for medical use Safety requirements
    DIN EN ISO 10524-4:2008-09 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS
    ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 8573-8:2004 Compressed air Part 8: Test methods for solid particle content by mass concentration
    DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
    ISO 8573-2:2007 Compressed air Part 2: Test methods for oil aerosol content
    ISO 10083:2006 Oxygen concentrator supply systems for use with medical gas pipeline systems
    DIN EN ISO 15001:2012-06 Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
    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 21969:2009 High-pressure flexible connections for use with medical gas systems
    ISO 5145:2014 Cylinder valve outlets for gases and gas mixtures Selection and dimensioning
    ISO 32:1977 Gas cylinders for medical use Marking for identification of content
    VDE 0750-211 : 2016
    DIN ISO 7183:1990-06 COMPRESSED AIR DRYERS - SPECIFICATIONS AND TESTING
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    CGA E 10 : 2013 MAINTENANCE OF MEDICAL GAS AND VACUUM SYSTEMS IN HEALTH CARE FACILITIES
    ISO 8573-1:2010 Compressed air Part 1: Contaminants and purity classes
    ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    DIN EN ISO 21969:2010-04 High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)
    ISO 8573-3:1999 Compressed air Part 3: Test methods for measurement of humidity
    EN 1041:2008+A1:2013 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
    ASSE SERIES 6000 : 2015 PROFESSIONAL QUALIFICATIONS STANDARD FOR MEDICAL GAS SYSTEMS PERSONNEL
    ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
    ISO 3746:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane
    ISO 11197:2016 Medical supply units
    ISO 11114-2:2013 Gas cylinders Compatibility of cylinder and valve materials with gas contents Part 2: Non-metallic materials
    EN 15908 : 2010 ANAESTHETIC AND RESPIRATORY EQUIPMENT - NON-INTERCHANGEABLE SCREW-THREADED (NIST) LOW-PRESSURE CONNECTORS FOR MEDICAL GASES
    DIN EN ISO 3746:2011-03 Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Survey method using an enveloping measurement surface over a reflecting plane (ISO 3746:2010)
    ISO 13585:2012 Brazing Qualification test of brazers and brazing operators
    NFPA 99 : 2018 HEALTH CARE FACILITIES CODE
    FD S90 155 : 2016 FD PIPELINE FOR COMPRESSED MEDICAL GASES AND VACUUM - ADDITIONAL ELEMENTS FOR DESIGN AND DELIVERY ACCEPTANCE
    ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    ISO 9001:2015 Quality management systems - Requirements
    ISO 29463-1:2017 High efficiency filters and filter media for removing particles from air Part 1: Classification, performance, testing and marking
    EN 14931:2006 Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing
    ISO 407:2004 Small medical gas cylinders Pin-index yoke-type valve connections
    EN 13134 : 2000 BRAZING - PROCEDURE APPROVAL
    ISO 8573-6:2003 Compressed air Part 6: Test methods for gaseous contaminant content
    DIN EN ISO 9001:2015-11 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015)
    AS 2896-2011 Medical gas systems - Installation and testing of non-flammable medical gas pipeline systems
    ISO/TR 7470:1988 Valve outlets for gas cylinders List of provisions which are either standardized or in use
    ISO 9170-1:2017 Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum
    DIN EN ISO 11114-1:2012-07 GAS CYLINDERS - COMPATIBILITY OF CYLINDER AND VALVE MATERIALS WITH GAS CONTENTS - PART 1: METALLIC MATERIALS (ISO 11114-1:2012 + AMD.1:2017)
    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
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    ISO 8573-4:2001 Compressed air Part 4: Test methods for solid particle content
    ISO 18082:2014 Anaesthetic and respiratory equipment Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases
    EN 286-1:1998/A2:2005 SIMPLE UNFIRED PRESSURE VESSELS DESIGNED TO CONTAIN AIR OR NITROGEN - PART 1: PRESSURE VESSELS FOR GENERAL PURPOSES
    DIN EN ISO 4135:2002-03 Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001); Trilingual version EN ISO 4135:2001
    CSA Z305.6 : 1992 MEDICAL OXYGEN CONCENTRATOR CENTRAL SUPPLY SYSTEM FOR USE WITH NONFLAMMABLE MEDICAL GAS PIPING SYSTEMS
    ISO 10524-2:2005 Pressure regulators for use with medical gases Part 2: Manifold and line pressure regulators
    DIN EN ISO 13585:2012-10 Brazing - Qualification test of brazers and brazing operators (ISO 13585:2012)
    DIN EN ISO 17672 : 2015 BRAZING - FILLER METALS (ISO 17672:2016)
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