DIN EN ISO 10524-1:2006-05
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 GAS - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES
Hardcopy , PDF
02-08-2019
English
01-01-2006
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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Superseded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 |
| Standards | Relationship |
| ISO 10524-1:2006 | Identical |
| NS EN ISO 10524-1 : 1ED 2006 | Identical |
| SN EN ISO 10524-1 : 2006 | Identical |
| NF EN ISO 10524-1 : 2006 | Identical |
| EN ISO 10524-1:2006 | Identical |
| BS EN ISO 10524-1:2006 | Identical |
| UNE-EN ISO 10524-1:2007 | Identical |
| NBN EN ISO 10524-1 : 2006 | Identical |
| NEN EN ISO 10524-1 : 2006 | Identical |
| I.S. EN ISO 10524-1:2006 | Identical |
| ONORM EN ISO 10524-1 : 2006 | Identical |
| EN ISO 10524-1:2019 | Identical |
| UNI EN ISO 10524-1 : 2006 | Identical |
| 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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