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  • EN ISO 10524-1:2006

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006)

    Available format(s): 

    Superseded date:  07-02-2019

    Language(s): 

    Published date:  01-02-2006

    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 methods for outlet pressure
      6.3 Test method for pressure-relief valve
      6.4 Test methods for leakage
      6.5 Test method for mechanical strength
      6.6 Test method for resistance to ignition
      6.7 Test method for accuracy of flow of pressure
           regulators fitted with flowmeters or flowgauges
      6.8 Test method for the stability of flow of pressure
           regulators fitted with flowmeters or flowgauges
      6.9 Test method for stability and accuracy of flow of
           pressure regulators fitted with fixed orifices
      6.10 Test method for flow setting and loosening torques
      6.11 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 pressure regulators
                          and pressure regulators with flow-metering
                          devices
    Annex B (informative) Rationale
    Annex C (informative) Reported regional and national deviations
                          of colour coding and nomenclature for
                          medical gases
    Bibliography
    ANNEX ZA (informative) Relationship between this European
                           Standard and the Essential Requirements
                           of EU Directive 93/42 EEC concerning
                           Medical Devices

    Abstract - (Show below) - (Hide below)

    ISO 10524-1:2006 is applicable to the types of pressure regulators listed and is intended for the administration of the following medical gases in the treatment, management, diagnostic evaluation and care of patients:oxygen;nitrous oxide;air for breathing;helium;carbon dioxide;xenon;mixtures of the gases listed above;air for driving surgical tools;nitrogen for driving surgical tools.These pressure regulators are intended to be fitted to cylinders with nominal filling pressures up to 25 000 kPa at 15 °C and can be provided with devices which control and measure the flow of the medical gas delivered.The types of pressure regulators covered by ISO 10524-1:2006 are as follows:pressure regulators intended to be connected to cylinders by the operator;pressure regulators with integral flow-metering devices intended to be connected to cylinders by the operator;pressure regulators that are an integral part of medical equipment (e.g. anaesthetic workstations, lung ventilators, resuscitators).

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

    Development Note Supersedes EN 738-1. (04/2006)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

    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
    EN 13544-1:2007+A1:2009 Respiratory therapy equipment - Part 1: Nebulizing systems and their components
    13/30276231 DC : 0 BS EN 13718-1 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN 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 1789:2014-12 MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
    DIN EN 13544-1:2009-12 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
    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
    I.S. EN 1789:2007 MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
    EN 1789:2007+A2:2014 Medical vehicles and their equipment - Road ambulances
    I.S. EN 13544-1:2007 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
    UNI EN 13544-1 : 2009 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
    BS EN 13544-1 : 2007 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
    EN 13718-1:2014 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
    BS EN 1789 : 2007 MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
    I.S. EN 13718-1:2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
    UNE-EN 1789:2007 Medical vehicles and their equipment - Road 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
    14/30289772 DC : 0 BS EN 1789:2007+A1:2010/A2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
    07/30147572 DC : DRAFT SEP 2007 BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
    UNI EN 1789 : 2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
    UNE-EN 13544-1:2007 Respiratory therapy equipment - Part 1: Nebulizing systems and their components

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

    EN 738-1:1997/A1:2002 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW METERING DEVICES
    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
    EN 737-1 : 1998 MEDICAL GAS PIPELINE SYSTEMS - TERMINAL UNITS FOR COMPRESSED MEDICAL GASES AND VACUUM
    EN 737-3:1998/A1:1999 MEDICAL GAS PIPELINE SYSTEMS - PIPELINES FOR COMPRESSED MEDICAL GASES AND VACUUM
    CGA C 9 : 2013 STANDARD COLOR MARKING OF COMPRESSED GAS CONTAINERS FOR MEDICAL USE
    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
    ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    ISO 2503:2009 Gas welding equipment Pressure regulators and pressure regulators with flow-metering devices for gas cylinders used in welding, cutting and allied processes up to 300 bar (30 MPa)
    ASTM G 175 : 2013 : REDLINE Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Pressure Regulators Used for Medical and Emergency Applications
    EN 739:1998/A1:2002 LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES
    EN 1089-3:2011 Transportable gas cylinders - Gas cylinder identification (excluding LPG) - Part 3: Colour coding
    ISO 407:2004 Small medical gas cylinders Pin-index yoke-type valve connections
    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
    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
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    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
    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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