I.S. EN ISO 7396-1:2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016)
Hardcopy , PDF
28-01-2020
English
03-04-2016
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.
Dates of withdrawal of national standards are available from NSAI.
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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 |
| Standards | Relationship |
| NBN EN ISO 7396-1 : 2016 | Identical |
| UNE-EN ISO 7396-1:2016 | Identical |
| SN EN ISO 7396-1:2016 | Identical |
| BS EN ISO 7396-1:2016 | Identical |
| UNI EN ISO 7396-1 : 2013 | Identical |
| NEN EN ISO 7396-1 : 2016 | Identical |
| NS EN ISO 7396-1 : 2016 | Identical |
| EN ISO 7396-1:2016 | Identical |
| ISO 7396-1:2016 | Identical |
| DIN EN ISO 7396-1:2016-09 | Identical |
| NF EN ISO 7396-1 : 2016 | Identical |
| ONORM EN ISO 7396-1 : 2016 | Identical |
| 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 |
| 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 |
| 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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