EN ISO 15002:2008
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)
27-11-2019
01-07-2008
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Arrangement of flow-metering systems and devices
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 method for mechanical strength
6.3 Test method for leakage
6.4 Test method for durability of markings and
colour coding
7 Marking, colour coding and packaging
7.1 Marking
7.2 Colour coding
7.3 Packaging
8 Information to be supplied by the manufacturer
Annex A (informative) - Rationale
Annex B (informative) - Arrangements of flow-metering
systems and devices
Annex C (informative) - Environmental aspects
Annex ZA (informative) - Correspondence between this
International Standard and Directive 93/42/EEC
Bibliography
ISO 15002:2008 is applicable to:flow-metering devices that are connected, either directly or by means of flexible connecting assemblies, and disconnected by the operator at terminal units of a medical gas pipeline system for flow adjustment, measurement and delivery of medical gases;flow-metering devices that are connected and disconnected by the operator at gas-specific connection points of devices such as pressure regulators.ISO 15002:2008 is applicable to:flow-metering devices intended to be used with the following medical gases:oxygen;nitrous oxide;medical air;carbon dioxide;oxygen/nitrous oxide mixture [50 %/50 % (by volume)]specified mixtures of the gases listed above;flow-metering devices intended to be used with the following gases:oxygen-enriched air;helium;xenon.
| Committee |
CEN/TC 215
|
| DevelopmentNote |
Supersedes EN 13220. (09/2008)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NBN EN ISO 15002 : 2008 | Identical |
| SS-EN ISO 15002 : 2008 | Identical |
| UNI EN ISO 15002 : 2020 | Identical |
| DIN EN ISO 15002:2008-11 | Identical |
| UNI EN ISO 15002 : 2008 | Identical |
| NEN EN ISO 15002 : 2008 | Identical |
| PN EN ISO 15002 : 2008 | Identical |
| ISO 15002:2008 | Identical |
| NF EN ISO 15002 : 2008 | Identical |
| NS EN ISO 15002 : 1ED 2008 | Identical |
| I.S. EN ISO 15002:2008 | Identical |
| SN EN ISO 15002:2008 | Identical |
| BS EN ISO 15002:2008 | Identical |
| UNE-EN ISO 15002:2008 | Identical |
| ONORM EN ISO 15002 : 2008 | Identical |
| DS EN ISO 15002 : 2008 | Identical |
| I.S. EN ISO 15002:2008&A1:2019 | 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 |
| 12/30266576 DC : 0 | BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES |
| 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 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 |
| 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 |
| UNI EN 1789 : 2014 | MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
| 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 |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| ISO 19054:2005 | Rail systems for supporting medical equipment |
| 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 |
| 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 |
| ISO/TR 15223:1998 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied |
| EN 1089-3:2011 | Transportable gas cylinders - Gas cylinder identification (excluding LPG) - Part 3: Colour coding |
| 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 |
| 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 |
| 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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