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EN ISO 15002:2008

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Superseded date

27-11-2019

Published date

01-07-2008

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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Superseded
Supersedes

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
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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