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EN ISO 7396-1:2016

Current
Current

The latest, up-to-date edition.

Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
Published date

03-16-2016

European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Supply systems
6 Monitoring and alarm systems
7 Pipeline distribution systems
8 Shut-off valves
9 Terminal units gas-specific connectors
   medical supply units pressure regulators
   and pressure gauges
10 Marking and colour coding
11 Pipeline installation
12 Testing and commissioning
13 Information to be supplied by the manufacturer
Annex A (informative) - Schematic representations of typical
        supply systems and area distribution systems
Annex B (informative) - Guidelines for location of cylinder
        manifolds cylinder storage areas and stationary vessels
        for cryogenic or non-cryogenic liquids
Annex C (informative) - Example of procedure for testing
        and commissioning
Annex D (informative) - Typical forms for documenting compliance
        of the pipeline systems for compressed medical gas and
        vacuum
Annex E (informative) - Temperature and pressure relationships
Annex F (informative) - Risk management checklist
Annex G (informative) - Operational management
Annex H (informative) - Rationale
Annex I (informative) - Rationale for compressor hazards
Annex J (informative) - Considerations for implementation and
        use of oxygen 93
Annex K (informative) - Manufacture of medical gases on site
        Responsibility for medical gas quality
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC
         on Medical devices

ISO 7396-1:2016 specifies requirements for design, installation, function, performance, testing, commissioning and documentation of pipeline systems used in healthcare facilities for the following:- oxygen;- nitrous oxide;- medical air;- carbon dioxide;- oxygen/nitrous oxide mixtures (see Note 1);- helium/oxygen mixtures;- (*) oxygen 93;- gases and gas mixtures classified as medical device, gases delivered to medical devices or intended for medical purposes or gases and gas mixtures for medicinal use not specified above;- air for driving surgical tools;- nitrogen for driving surgical tools;- vacuum.NOTE 1 Regional or national regulations may prohibit the distribution of oxygen/nitrous oxide mixtures in medical gas pipeline systems.NOTE 2 Anaesthetic gas scavenging disposal systems are covered in ISO 7396‑2.This part of ISO 7396 includes requirements for supply systems, pipeline distribution systems, control systems, monitoring and alarm systems and non-interchangeability between components of different gas/vacuum systems.This part of ISO 7396 specifies safety requirements for pipeline systems used in healthcare facilities, both public and private. It applies to all facilities providing healthcare services regardless of type, size, location or range of services, including, but not limited to:a) acute care healthcare facilities;b) internal patient continuing care healthcare facilities;c) long-term care facilities;d) community-based providers;e) ambulatory and external patient care clinics (e.g. day surgery, endoscopy clinics and doctors' offices).NOTE 3 This part of ISO 7396 may also be used as reference for pipeline systems for medical gases and vacuum intended to be installed in places other than healthcare facilities.ISO 7396-1:2016 applies to the following different types of oxygen supply systems:- supply systems in which all sources of supply deliver oxygen; in this case the concentration of the oxygen will be greater than 99%;- supply systems in which all sources of supply deliver oxygen 93; in this case the concentration of the oxygen may vary between 90% and 96%;NOTE 4 A mixture of oxygen 93 and oxygen may be delivered by a medical gas supply system. In this case the concentration of the gas can vary between 90% and >99%.ISO 7396-1:2016 also applies to:- extensions of existing pipeline distribution systems;- modifications of existing pipeline distribution systems;- modifications or replacement of supply systems or sources of supply.Oxygen concentrators for domiciliary use are excluded from the scope of this part of ISO 7396.NOTE 5 Requirements for oxygen concentrators for domiciliary use are specified in ISO 80601‑2-69.(*) EN 14931 defines additional requirements for hyperbaric application, in particular for flows and pressures of compressed air required to pressurize the hyperbaric chamber and to drive other connected services. Also included are requirements for oxygen and other treatment gases administered to patients.ISO 7396-1:2016 does not apply to vacuum systems intended to be used in dentistry.ISO 7396-1:2016 does not apply to filling systems for transportable cylinders and transportable cylinder bundle systems.

Committee
CEN/TC 215
DevelopmentNote
Supersedes EN 737-3. (06/2007) Supersedes PREN ISO 7396-1. (12/2007)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current
Supersedes

12/30266576 DC : 0 BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES
EN 13718-2:2015 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
BS EN 13348:2016 Copper and copper alloys. Seamless, round copper tubes for medical gases or vacuum
EN 13348:2016 Copper and copper alloys - Seamless, round copper tubes for medical gases or vacuum
EN 13544-1:2007+A1:2009 Respiratory therapy equipment - Part 1: Nebulizing systems and their components
17/30338753 DC : 0 BS ISO 80601-2-79 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-79: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY IMPAIRMENT
BS EN 13976-1:2011 Rescue systems. Transportation of incubators Interface conditions
EN 13976-1:2011 Rescue systems - Transportation of incubators - Part 1: Interface conditions
I.S. EN 13348:2016 COPPER AND COPPER ALLOYS - SEAMLESS, ROUND COPPER TUBES FOR MEDICAL GASES OR VACUUM
09/30205924 DC : 0 BS EN 13976-1 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
UNE-EN 13976-1:2011 Rescue systems - Transportation of incubators - Part 1: Interface conditions
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
I.S. EN 13544-1:2007 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
UNI EN 13348 : 2008 COPPER AND COPPER ALLOYS - SEAMLESS, ROUND COPPER TUBES FOR MEDICAL GASES OR VACUUM
UNI EN 13544-1 : 2009 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
17/30338756 DC : 0 BS ISO 80601-2-80 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-80: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY INSUFFICIENCY
16/30333928 DC : 0 BS EN 13976-1 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
UNI EN 13976-1 : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
UNE-EN 13718-2:2015 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
BS EN 13544-1 : 2007 RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
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
UNE-EN 13348:2016 Copper and copper alloys - Seamless, round copper tubes for medical gases or vacuum
I.S. EN 13718-2:2015+A1:2020 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
DIN EN 13976-1 E : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
07/30147572 DC : DRAFT SEP 2007 BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
DIN EN 13976-1:2016-03 (Draft) RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
I.S. EN 13976-1:2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
DIN EN 13976-1:2011-08 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
UNE-EN 13544-1:2007 Respiratory therapy equipment - Part 1: Nebulizing systems and their components

ISO 7183:2007 Compressed-air dryers Specifications and testing
ISO 17672:2016 Brazing Filler metals
ISO 8573-5:2001 Compressed air — Part 5: Test methods for oil vapour and organic solvent content
ISO 80601-2-69:2014 Medical electrical equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
EN 1254-4:1998/AC:1999 COPPER AND COPPER ALLOYS - PLUMBING FITTINGS - PART 4: FITTINGS COMBINING OTHER END CONNECTIONS WITH CAPILLARY OR COMPRESSION ENDS
ISO 11114-1:2012 Gas cylinders Compatibility of cylinder and valve materials with gas contents Part 1: Metallic materials
Z7396.1-17 Medical gas pipeline systems - Part 1: Pipelines for medical gases, medical vacuum, medical support gases, and anaesthetic gas scavenging systems
EN 12021:2014 Respiratory equipment - Compressed gases for breathing apparatus
ISO 4126-1:2013 Safety devices for protection against excessive pressure — Part 1: Safety valves
CSA B51 : 2014 BOILER, PRESSURE VESSEL, AND PRESSURE PIPING CODE
CGA P 8.1 : 2016 SAFE INSTALLATION AND OPERATION OF PSA AND MEMBRANE OXYGEN AND NITROGEN GENERATORS
ISO 10524-4:2008 Pressure regulators for use with medical gases — Part 4: Low-pressure regulators
EN 1254-1:1998 Copper and copper alloys - Plumbing fittings - Part 1: Fittings with ends for capillary soldering or capillary brazing to copper tubes
EN 475 : 1995 MEDICAL DEVICES - ELECTRICALLY GENERATED ALARM SIGNALS
ISO 8359:1996 Oxygen concentrators for medical use Safety requirements
ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 8573-8:2004 Compressed air — Part 8: Test methods for solid particle content by mass concentration
ISO 8573-2:2007 Compressed air Part 2: Test methods for oil aerosol content
ISO 10083:2006 Oxygen concentrator supply systems for use with medical gas pipeline systems
IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
ISO 7396-2:2007 Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems
ISO 21969:2009 High-pressure flexible connections for use with medical gas systems
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
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
CGA E 10 : 2013 MAINTENANCE OF MEDICAL GAS AND VACUUM SYSTEMS IN HEALTH CARE FACILITIES
ISO 8573-1:2010 Compressed air Part 1: Contaminants and purity classes
ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
ISO 8573-3:1999 Compressed air Part 3: Test methods for measurement of humidity
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ASSE SERIES 6000 : 2015 PROFESSIONAL QUALIFICATIONS STANDARD FOR MEDICAL GAS SYSTEMS PERSONNEL
ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
ISO 3746:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane
ISO 11197:2016 Medical supply units
ISO 11114-2:2013 Gas cylinders Compatibility of cylinder and valve materials with gas contents Part 2: Non-metallic materials
EN 15908:2010 Anaesthetic and respiratory equipment - Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases
ISO 13585:2012 Brazing Qualification test of brazers and brazing operators
NFPA 99 : 2018 HEALTH CARE FACILITIES CODE
FD S90 155 : 2016 FD PIPELINE FOR COMPRESSED MEDICAL GASES AND VACUUM - ADDITIONAL ELEMENTS FOR DESIGN AND DELIVERY ACCEPTANCE
ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
ISO 9001:2015 Quality management systems — Requirements
ISO 29463-1:2017 High efficiency filters and filter media for removing particles from air Part 1: Classification, performance, testing and marking
EN 14931:2006 Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing
ISO 407:2004 Small medical gas cylinders Pin-index yoke-type valve connections
EN 13134:2000 Brazing - Procedure approval
ISO 8573-6:2003 Compressed air — Part 6: Test methods for gaseous contaminant content
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
ISO 14971:2007 Medical devices Application of risk management to medical devices
EN 13348:2016 Copper and copper alloys - Seamless, round copper tubes for medical gases or vacuum
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
ISO 8573-4:2001 Compressed air Part 4: Test methods for solid particle content
ISO 18082:2014 Anaesthetic and respiratory equipment Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases
EN 286-1:1998/A2:2005 SIMPLE UNFIRED PRESSURE VESSELS DESIGNED TO CONTAIN AIR OR NITROGEN - PART 1: PRESSURE VESSELS FOR GENERAL PURPOSES
CSA Z305.6 : 1992 MEDICAL OXYGEN CONCENTRATOR CENTRAL SUPPLY SYSTEM FOR USE WITH NONFLAMMABLE MEDICAL GAS PIPING SYSTEMS
ISO 10524-2:2005 Pressure regulators for use with medical gases Part 2: Manifold and line pressure regulators

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