EN ISO 10524-4:2008
Current
The latest, up-to-date edition.
Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)
01-06-2008
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 conditions
6.3 Test method for outlet pressure
6.4 Test methods for leakage
6.5 Test method for mechanical strength
6.6 Test method for accuracy of flow of pressure
regulators fitted with flowmeters or flowgauges
6.7 Test method for the stability of flow of pressure
regulators fitted with flowmeters or flowgauges
6.8 Test method for stability and accuracy of flow
of pressure regulators fitted with fixed orifices
6.9 Test method for loosening torque
6.10 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 low-pressure
regulators
Annex B (informative) - Rationale
Annex C (informative) - Reported regional and national
deviations of colour coding and
nomenclature for medical gases
Annex D (informative) - Environmental aspects
Annex ZA (informative) - Correspondence between this International
Standard and Directive 93/42/EEC
Bibliography
ISO 10524-4:2008 applies to the types of low-pressure regulators listed below and intended to be used with the following medical gases in the treatment, management, diagnostic evaluation and care of patients:oxygen;nitrous oxide;medical air;helium;carbon dioxide;xenon;specified mixtures of the gases listed above;air for driving surgical tools;nitrogen for driving surgical tools;oxygen-enriched air.The types of low-pressure regulators covered by ISO 10524-4:2008 are as follows:low-pressure regulators intended to be connected to terminal units of medical gas pipeline systems complying with ISO 7396-1;low-pressure regulators with integral flow-metering devices intended to be connected to terminal units of medical gas pipeline systems complying with ISO 7396-1;low-pressure regulators intended to be connected to terminal units attached to pressure regulators complying with ISO 10524-1 or ISO 10524-3;operator-adjustable low-pressure regulators for air or nitrogen for driving surgical tools that are an integral part of a medical gas pipeline system complying with ISO 7396-1.
| Committee |
CEN/TC 215
|
| DevelopmentNote |
Supersedes EN 738-4. (08/2008)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NF EN ISO 10524-4 : 2008 | Identical |
| DIN EN ISO 10524-4:2008-09 | Identical |
| NEN EN ISO 10524-4 : 2008 | Identical |
| BS EN ISO 10524-4:2008 | Identical |
| SN EN ISO 10524-4 : 2008 | Identical |
| PN EN ISO 10524-4 : 2008 | Identical |
| NBN EN ISO 10524-4 : 2008 | Identical |
| ISO 10524-4:2008 | Identical |
| NS EN ISO 10524-4 : 1ED 2008 | Identical |
| UNE-EN ISO 10524-4:2008 | Identical |
| UNI EN ISO 10524-4 : 2008 | Identical |
| I.S. EN ISO 10524-4:2008 | Identical |
| SS-EN ISO 10524-4 : 2008 | 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 |
| 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 13220 : 1998 | FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
| ISO 15002:2008 | Flow-metering devices for connection to terminal units of medical gas pipeline systems |
| 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 |
| ISO 11114-3:2010 | Gas cylinders Compatibility of cylinder and valve materials with gas contents Part 3: Autogenous ignition test for non-metallic materials in oxygen atmosphere |
| CGA C 9 : 2013 | STANDARD COLOR MARKING OF COMPRESSED GAS CONTAINERS FOR MEDICAL USE |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| 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 10524-3:2005 | Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves |
| EN 1089-3:2011 | Transportable gas cylinders - Gas cylinder identification (excluding LPG) - Part 3: Colour coding |
| AS 2896-2011 | Medical gas systems - Installation and testing of non-flammable medical gas pipeline systems |
| 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 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 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| 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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