ISO 7396-1:2016
Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
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.
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Foreword
Introduction
1 (*) Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 (*) Safety
4.2 (*) Alternative construction
4.3 Materials
4.4 System design
4.4.1 General
4.4.2 Extensions and modifications of existing pipeline systems
5 Supply systems
5.1 System components
5.2 General requirements
5.2.1 Capacity and storage
5.2.2 Continuity of supply
5.2.3 Primary source of supply
5.2.4 Secondary source of supply
5.2.5 Reserve source(s) of supply
5.2.6 Means of pressure relief
5.2.7 Maintenance supply assembly
5.2.8 Pressure regulators
5.2.9 (*)Ozone Sterilizers
5.3 Supply systems with cylinders, cylinder bundles or high-pressure reservoir(s)
5.4 Supply systems with cryogenic or non-cryogenic vessels
5.5 Supply systems for air
5.5.1 General requirements
5.5.2 Supply systems with air compressor(s)
5.5.3 Supply systems with proportioning unit(s)
5.6 Supply systems with oxygen concentrator(s)
5.6.1 General requirements
5.6.2 Primary source of supply
5.6.3 Secondary source of supply
5.6.4 Reserve source of supply
5.6.5 Specifications for oxygen 93
5.6.6 Oxygen concentrator unit
5.6.7 Oxygen 93 reservoirs
5.6.8 Oxygen analysers
5.6.9 Local filling of permanently attached high-pressure reservoir(s), acting as reserve source of supply
5.7 Supply systems for vacuum
5.8 Location of supply systems
5.9 Location of cylinder manifolds
5.10 Location of stationary cryogenic vessels
6 Monitoring and alarm systems
6.1 General
6.2 Installation requirements
6.3 Monitoring and alarm signals
6.3.1 General
6.3.2 Auditory signals
6.3.3 Visual signals
6.3.4 Emergency and operating alarm characteristics
6.3.5 Information signals
6.3.6 Remote alarm extensions
6.4 Provision of operating alarms
6.5 Provision of emergency clinical alarms
6.6 (*) Provision of emergency operating alarms
7 Pipeline distribution systems
7.1 Mechanical resistance
7.2 Distribution pressure
7.3 Low-pressure hose assemblies and low-pressure flexible connections
7.4 Double-stage pipeline distribution systems
8 Shut-off valves
8.1 General
8.2 Service shut-off valves
8.3 Area shut-off valves
9 Terminal units, gas-specific connectors, medical supply units, pressure regulators and pressure gauges
10 Marking and colour coding
10.1 Marking
10.2 Colour coding
11 Pipeline installation
11.1 General
11.2 Pipeline supports
11.3 Pipeline joints
11.4 Extensions and modifications of existing pipeline systems
12 Testing and commissioning
12.1 General
12.2 General requirements for tests
12.3 Inspections and checks before concealment
12.4 Tests, checks and procedures before use of the system
12.5 Requirements for inspections and checks before concealment
12.5.1 Inspection of marking and pipeline supports
12.5.2 Check for compliance with design specifications
12.6 Requirements for tests, checks and procedures before use of the system
12.6.1 General
12.6.2 (*) Tests of area shut-off valves for leakage and closure and checks for correct zoning and correct identification
12.6.3 Test for cross-connection
12.6.4 Test for obstruction and flow
12.6.5 Checks of terminal units and NIST, DISS or SIS connectors for mechanical function, gas specificity and identification
12.6.6 Tests or checks of system performance
12.6.7 (*) Tests of pressure-relief valves
12.6.8 Tests of all sources of supply
12.6.9 Tests of monitoring and alarm systems
12.6.10 Test for particulate contamination of pipeline distribution systems
12.6.11 Tests of the quality of medical air produced by supply systems with air compressor(s)
12.6.12 Tests of the quality of air for driving surgical tools produced by supply systems with air compressor(s)
12.6.13 Tests of the quality of medical air produced by supply systems with proportioning unit(s)
12.6.14 Tests of the quality of oxygen 93 produced by supply systems with oxygen concentrator(s)
12.6.15 Filling with specific gas
12.6.16 Tests of gas identity
12.6.17 Verification of restart after power supply failure
12.7 Statement of compliance to this part of ISO 7396
13 Information to be supplied by the manufacturer
13.1 General
13.2 Instructions for installation
13.3 Instructions for use
13.4 Operational management information
13.5 “As-installed” drawings
13.6 Electrical diagrams
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
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Foreword
Introduction
1 (*) Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 (*) Safety
4.2 (*) Alternative construction
4.3 Materials
4.4 System design
4.4.1 General
4.4.2 Extensions and modifications of existing pipeline systems
5 Supply systems
5.1 System components
5.2 General requirements
5.2.1 Capacity and storage
5.2.2 Continuity of supply
5.2.3 Primary source of supply
5.2.4 Secondary source of supply
5.2.5 Reserve source(s) of supply
5.2.6 Means of pressure relief
5.2.7 Maintenance supply assembly
5.2.8 Pressure regulators
5.2.9 (*)Ozone Sterilizers
5.3 Supply systems with cylinders, cylinder bundles or high-pressure reservoir(s)
5.4 Supply systems with cryogenic or non-cryogenic vessels
5.5 Supply systems for air
5.5.1 General requirements
5.5.2 Supply systems with air compressor(s)
5.5.3 Supply systems with proportioning unit(s)
5.6 Supply systems with oxygen concentrator(s)
5.6.1 General requirements
5.6.2 Primary source of supply
5.6.3 Secondary source of supply
5.6.4 Reserve source of supply
5.6.5 Specifications for oxygen 93
5.6.6 Oxygen concentrator unit
5.6.7 Oxygen 93 reservoirs
5.6.8 Oxygen analysers
5.6.9 Local filling of permanently attached high-pressure reservoir(s), acting as reserve source of supply
5.7 Supply systems for vacuum
5.8 Location of supply systems
5.9 Location of cylinder manifolds
5.10 Location of stationary cryogenic vessels
6 Monitoring and alarm systems
6.1 General
6.2 Installation requirements
6.3 Monitoring and alarm signals
6.3.1 General
6.3.2 Auditory signals
6.3.3 Visual signals
6.3.4 Emergency and operating alarm characteristics
6.3.5 Information signals
6.3.6 Remote alarm extensions
6.4 Provision of operating alarms
6.5 Provision of emergency clinical alarms
6.6 (*) Provision of emergency operating alarms
7 Pipeline distribution systems
7.1 Mechanical resistance
7.2 Distribution pressure
7.3 Low-pressure hose assemblies and low-pressure flexible connections
7.4 Double-stage pipeline distribution systems
8 Shut-off valves
8.1 General
8.2 Service shut-off valves
8.3 Area shut-off valves
9 Terminal units, gas-specific connectors, medical supply units, pressure regulators and pressure gauges
10 Marking and colour coding
10.1 Marking
10.2 Colour coding
11 Pipeline installation
11.1 General
11.2 Pipeline supports
11.3 Pipeline joints
11.4 Extensions and modifications of existing pipeline systems
12 Testing and commissioning
12.1 General
12.2 General requirements for tests
12.3 Inspections and checks before concealment
12.4 Tests, checks and procedures before use of the system
12.5 Requirements for inspections and checks before concealment
12.5.1 Inspection of marking and pipeline supports
12.5.2 Check for compliance with design specifications
12.6 Requirements for tests, checks and procedures before use of the system
12.6.1 General
12.6.2 (*) Tests of area shut-off valves for leakage and closure and checks for correct zoning and correct identification
12.6.3 Test for cross-connection
12.6.4 Test for obstruction and flow
12.6.5 Checks of terminal units and NIST, DISS or SIS connectors for mechanical function, gas specificity and identification
12.6.6 Tests or checks of system performance
12.6.7 (*) Tests of pressure-relief valves
12.6.8 Tests of all sources of supply
12.6.9 Tests of monitoring and alarm systems
12.6.10 Test for particulate contamination of pipeline distribution systems
12.6.11 Tests of the quality of medical air produced by supply systems with air compressor(s)
12.6.12 Tests of the quality of air for driving surgical tools produced by supply systems with air compressor(s)
12.6.13 Tests of the quality of medical air produced by supply systems with proportioning unit(s)
12.6.14 Tests of the quality of oxygen 93 produced by supply systems with oxygen concentrator(s)
12.6.15 Filling with specific gas
12.6.16 Tests of gas identity
12.6.17 Verification of restart after power supply failure
12.7 Statement of compliance to this part of ISO 7396
13 Information to be supplied by the manufacturer
13.1 General
13.2 Instructions for installation
13.3 Instructions for use
13.4 Operational management information
13.5 “As-installed” drawings
13.6 Electrical diagrams
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