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I.S. EN ISO 7396-1:2016

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016)
Available format(s)

Hardcopy , PDF

Superseded date

01-28-2020

Language(s)

English

Published date

04-03-2016

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

National Foreword
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

This part of ISO 7396 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.

Committee
TC 121
DevelopmentNote
Supersedes I.S. EN 737-3 and I.S. ISO 7396. (06/2007)
DocumentType
Standard
Pages
200
ProductNote
The date of any NSAIprevious adoption may not matchthe date of its original CEN/CENELEC document THIS STANDARD ALSO REFERS TO :EN 286-1:1998, EN 1041:2008, EN 1254-4:1998, EN 13348:2008,HTM 02/01:2006,SIS/HB 370
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy
Supersedes

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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