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  • EN ISO 10524-4:2008

    Current The latest, up-to-date edition.

    Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)

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    Published date:  01-06-2008

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Nomenclature
    5 General requirements
      5.1 Safety
      5.2 Alternative construction
      5.3 Materials
      5.4 Design requirements
      5.5 Constructional requirements
    6 Test methods
      6.1 General
      6.2 Test conditions
      6.3 Test method for outlet pressure
      6.4 Test methods for leakage
      6.5 Test method for mechanical strength
      6.6 Test method for accuracy of flow of pressure
           regulators fitted with flowmeters or flowgauges
      6.7 Test method for the stability of flow of pressure
           regulators fitted with flowmeters or flowgauges
      6.8 Test method for stability and accuracy of flow
           of pressure regulators fitted with fixed orifices
      6.9 Test method for loosening torque
      6.10 Test method for durability of markings and
           colour coding
    7 Marking, colour coding, packaging
      7.1 Marking
      7.2 Colour coding
      7.3 Packaging
    8 Information to be supplied by the manufacturer
    Annex A (informative) - Typical examples of low-pressure
                            regulators
    Annex B (informative) - Rationale
    Annex C (informative) - Reported regional and national
                            deviations of colour coding and
                            nomenclature for medical gases
    Annex D (informative) - Environmental aspects
    Annex ZA (informative) - Correspondence between this International
                             Standard and Directive 93/42/EEC
    Bibliography

    Abstract - (Show below) - (Hide below)

    ISO 10524-4:2008 applies to the types of low-pressure regulators listed below and intended to be used with the following medical gases in the treatment, management, diagnostic evaluation and care of patients:oxygen;nitrous oxide;medical air;helium;carbon dioxide;xenon;specified mixtures of the gases listed above;air for driving surgical tools;nitrogen for driving surgical tools;oxygen-enriched air.The types of low-pressure regulators covered by ISO 10524-4:2008 are as follows:low-pressure regulators intended to be connected to terminal units of medical gas pipeline systems complying with ISO 7396-1;low-pressure regulators with integral flow-metering devices intended to be connected to terminal units of medical gas pipeline systems complying with ISO 7396-1;low-pressure regulators intended to be connected to terminal units attached to pressure regulators complying with ISO 10524-1 or ISO 10524-3;operator-adjustable low-pressure regulators for air or nitrogen for driving surgical tools that are an integral part of a medical gas pipeline system complying with ISO 7396-1.

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

    Committee CEN/TC 215
    Development Note Supersedes EN 738-4. (08/2008)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current
    Supersedes

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

    BS EN 13718-1:2014 Medical vehicles and their equipment. Air ambulances Requirements for medical devices used in air ambulances
    EN 13718-2:2015 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
    UNI EN 13718-1 : 2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
    DIN EN 13718-2:2015-05 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
    DIN EN 13718-1:2014-12 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
    UNE-EN 13718-2:2015 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
    EN 13718-1:2014 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
    I.S. EN 13718-1:2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
    BS EN 13718-2:2015 Medical vehicles and their equipment. Air ambulances Operational and technical requirements for air ambulances
    I.S. EN 13718-2:2015 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
    I.S. EN 13718-2:2015+A1:2020 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES

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

    EN 13220 : 1998 FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS
    ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems
    CGSB 24.2 : M86 IDENTIFICATION OF MEDICAL GAS CONTAINERS, PIPELINES AND VALVES
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
    ISO 11114-3:2010 Gas cylinders Compatibility of cylinder and valve materials with gas contents Part 3: Autogenous ignition test for non-metallic materials in oxygen atmosphere
    CGA C 9 : 2013 STANDARD COLOR MARKING OF COMPRESSED GAS CONTAINERS FOR MEDICAL USE
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    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
    ISO 10524-3:2005 Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves
    EN 1089-3:2011 Transportable gas cylinders - Gas cylinder identification (excluding LPG) - Part 3: Colour coding
    AS 2896-2011 Medical gas systems - Installation and testing of non-flammable medical gas pipeline systems
    ISO 9170-1:2017 Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum
    AS 4484:2016 Gas cylinders for industrial, scientific, medical and refrigerant use - Labelling and colour coding
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN 837-1:1996/AC:1998 PRESSURE GAUGES - BOURDON TUBE PRESSURE GAUGES - DIMENSIONS, METROLOGY, REQUIREMENTS AND TESTING
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    ISO 10524-1:2006 Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    EN 13544-2:2002+A1:2009 Respiratory therapy equipment - Part 2: Tubing and connectors
    ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
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