EN ISO 10524-1:2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
07-02-2019
01-02-2006
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
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).
| DevelopmentNote |
Supersedes EN 738-1. (04/2006)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| DS EN ISO 10524-1 : 2006 | Identical |
| DS/EN ISO 10524-1:2019 | Identical |
| UNE-EN ISO 10524-1:2007 | Identical |
| NBN EN ISO 10524-1 : 2006 | Identical |
| NEN-EN-ISO 10524-1:2019 | Identical |
| NEN EN ISO 10524-1 : 2006 | Identical |
| ISO 10524-1:2018 | Identical |
| PN EN ISO 10524-1 : 2006 | Identical |
| NS EN ISO 10524-1 : 1ED 2006 | Identical |
| PN-EN ISO 10524-1 : 2019 | Identical |
| UNI EN ISO 10524-1:2019 | Identical |
| I.S. EN ISO 10524-1:2006 | Identical |
| ONORM EN ISO 10524-1 : 2006 | Identical |
| BS EN ISO 10524-1:2006 | Identical |
| NS-EN ISO 10524-1:2019 | Identical |
| DIN EN ISO 10524-1:2006-05 | Identical |
| I.S. EN ISO 10524-1:2019 | Identical |
| UNI EN ISO 10524-1 : 2006 | Identical |
| ISO 10524-1:2006 | Identical |
| SN EN ISO 10524-1 : 2006 | Identical |
| NF EN ISO 10524-1 : 2006 | Identical |
| 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 |
| 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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