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DIN EN ISO 10524-1:2006-05

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 GAS - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES
Available format(s)

Hardcopy , PDF

Superseded date

08-02-2019

Language(s)

English

Published date

01-01-2006

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

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.

DevelopmentNote
Supersedes DIN EN 738-1. (05/2006) DRAFT 2017 issued in April 2017. (04/2017)
DocumentType
Standard
Pages
40
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
SupersededBy
Supersedes

DIN EN ISO 10524-4:2008-09 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS
DIN EN ISO 21969:2010-04 High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)
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 10079-3:2014-09 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014)
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)

EN 738-1:1997/A1:2002 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW METERING DEVICES
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
DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
DIN EN ISO 15001:2012-06 Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
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)
EN 739:1998/A1:2002 LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES
DIN EN ISO 2503:2015-12 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) (ISO 2503:2009 + AMD 1:2015)
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
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
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
VDE 0750-1 : 2013 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012)
DIN EN ISO 4135:2002-03 Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001); Trilingual version EN ISO 4135:2001
ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum

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