• ONORM EN ISO 10524-1 : 2006

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES

    Available format(s): 

    Withdrawn date:  15-07-2019

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Osterreichisches Normungsinstitut/Austrian Standards

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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)

    Applies 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.

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

    Development Note Supersedes ONORM EN 738-1 (05/2006)
    Document Type Standard
    Publisher Osterreichisches Normungsinstitut/Austrian Standards
    Status Withdrawn
    Superseded By

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

    ONORM EN 13718-1 : 2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
    ONORM EN 1789 : 2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
    ONORM EN 13718-2 : 2015 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
    ONORM EN 13544-3 : 2010 RESPIRATORY THERAPY EQUIPMENT - PART 3: AIR ENTRAINMENT DEVICES

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

    ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
    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 407:2004 Small medical gas cylinders Pin-index yoke-type valve connections
    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 837-1:1996/AC:1998 PRESSURE GAUGES - BOURDON TUBE PRESSURE GAUGES - DIMENSIONS, METROLOGY, REQUIREMENTS AND TESTING
    EN 13544-2:2002+A1:2009 Respiratory therapy equipment - Part 2: Tubing and connectors
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