• EN ISO 10524-2:2006

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)

    Available format(s): 

    Superseded date:  07-02-2019

    Language(s): 

    Published date:  26-04-2006

    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 Symbols
    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 Conditions
      6.2 Test methods for manifold pressure regulators
      6.3 Test methods for line pressure regulators
      6.4 Test method for determination of the auto-ignition
          temperature of sealing materials and lubricants
      6.5 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) Examples of pressure regulators
    Annex B (informative) Rationale
    Annex C (informative) Reported regional and national
            deviations of colour coding and nomenclature
            for medical gases
    Annex ZA (informative) Relationship between this European
             Standard and the Essential Requirements of EU
             Directive 93/42/EEC Medical Devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    ISO 10524-2:2005 specifies requirements for manifold pressure regulators intended to be connected to cylinders with nominal filling pressures up to 25 000 kPa at 15 °C and for line pressure regulators for inlet pressures up to 3 000 kPa and intended for use in pipeline systems for the following medical gases:oxygen; nitrous oxide; air for breathing; carbon dioxide; oxygen/nitrous oxide mixtures; air for driving surgical tools; nitrogen for driving surgical tools; oxygen produced by an oxygen concentrator. ISO 10524-2:2005 applies to manifold pressure regulators and line pressure regulators supplied as individual units or to the relevant components incorporated within an assembly. It does not apply to pressure regulators for use with vacuum pipeline systems.

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

    Committee CEN/TC 215
    Development Note Supersedes EN 738-2. (07/2006)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

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

    BS EN 14931:2006 Pressure vessels for human occupancy (PVHO). Multi-place pressure chambers for hyperbaric therapy. Performance, safety requirements and testing
    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
    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 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
    EN 14931:2006 Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing

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

    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 738-2 : 1998 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - MANIFOLD AND LINE - PRESSURE REGULATORS
    ISO 4126-7:2013 Safety devices for protection against excessive pressure — Part 7: Common data
    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 32:1977 Gas cylinders for medical use — Marking for identification of content
    ISO 7291:2010 Gas welding equipment Pressure regulators for manifold systems used in welding, cutting and allied processes up to 30 MPa (300 bar)
    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 1089-3:2011 Transportable gas cylinders - Gas cylinder identification (excluding LPG) - Part 3: Colour coding
    ISO 10079-3:2014 Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source
    AS 2896-2011 Medical gas systems - Installation and testing of non-flammable medical gas pipeline systems
    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 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
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