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13/30255929 DC : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS EN ISO 7396-1 - MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM
Available format(s)

Hardcopy , PDF

Superseded date

31-03-2016

Language(s)

English

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, commissioning and certification
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 certification of
        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 and oxygen 90+
Annex K (informative) - Manufacture of medical gases on
        site - Responsibility for medical gas quality
Annex L - Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC Medical Devices

BS EN ISO 7396-1

Committee
CH/121/6
DocumentType
Draft
Pages
222
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

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
EN 1254-4:1998/AC:1999 COPPER AND COPPER ALLOYS - PLUMBING FITTINGS - PART 4: FITTINGS COMBINING OTHER END CONNECTIONS WITH CAPILLARY OR COMPRESSION ENDS
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
ISO 7183-2:1996 Compressed air dryers Part 2: Performance ratings
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
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
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
EN ISO 13585:2012 Brazing - Qualification test of brazers and brazing operators (ISO 13585:2012)
EN 15908:2010 Anaesthetic and respiratory equipment - Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases
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
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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