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ISO 7396-1:2016 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum >
ISO 7396-1:2016 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum, 2016
- 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 [Go to Page]