Medical gas pipeline systems – Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)
Abstract
ISO 7396-1:2007 specifies requirements for design, installation, function, performance, documentation, testing and commissioning of pipeline systems for compressed medical gases, gases for driving surgical tools and vacuum in healthcare facilities to ensure continuous delivery of the correct gas and the provision of vacuum from the pipeline system. It includes requirements for supply systems, pipeline distribution systems, control systems, monitoring and alarm systems and non-interchangeability between components of different gas systems.
ISO 7396-1:2007 is applicable to pipeline systems for the following medical gases: oxygen, nitrous oxide, medical air, carbon dioxide, oxygen/nitrous oxide mixtures; to pipeline systems for the following gases: oxygen-enriched air, air for driving surgical tools, nitrogen for driving surgical tools; and to pipeline systems for vacuum.
ISO 7396-1:2007 also applies to extensions of existing pipeline distribution systems, modifications of existing pipeline distribution systems and modifications or replacement of supply systems or sources of supply.
DIN EN ISO 7396-1:2010-08 (E)
Medical gas pipeline systems – Part 1: Pipeline systems for comp ressed medical
gases and vacuum (ISO 7396-1:2007 + Amd 1:2010 + Amd 2:2010) (includes
Amendment A1:2010 + Amendment A2:2010)
Contents Page
Introduction ……………………………………………………………………………………………………………………………………6
1 Scope ……………………………………………………………………………………………………………………………..7
2 Normative references ……………………………………………………………………………………………………..8
3 Terms and definitions ……………………………………………………………………………………………………..8
4 General requirements ……………………………………………………………………………………………………13
4.1 (*) Safety ……………………………………………………………………………………………………………………….13
4.2 (*) Alternative construction ……………………………………………………………………………………………13
4.3 Materials ……………………………………………………………………………………………………………………….14
4.4 System design ………………………………………………………………………………………………………………15
5 Supply systems …………………………………………………………………………………………………………….16
5.1 System components ……………………………………………………………………………………………………..16
5.2 General requirements ……………………………………………………………………………………………………16
5.3 Supply systems with cylinders or cylinder bundles ……………………………………………………….18
5.4 Supply systems with mobile or stationary cryogenic or non-cryogenic vessels ……………..19
5.5 Supply systems for air …………………………………………………………………………………………………..19
5.6 Supply systems with oxygen concentrator(s) ………………………………………………………………..23
5.7 Supply systems for vacuum ………………………………………………………………………………………….24
5.8 Location of supply systems …………………………………………………………………………………………..24
5.9 Location of cylinder manifolds ………………………………………………………………………………………25
5.10 Location of stationary cryogenic vessels ………………………………………………………………………25
6 Monitoring and alarm systems ………………………………………………………………………………………25
6.1 General …………………………………………………………………………………………………………………………25
6.2 Installation requirements ………………………………………………………………………………………………25
6.3 Monitoring and alarm signals ………………………………………………………………………………………..26
6.4 Provision of operating alarms ……………………………………………………………………………………….27
6.5 Provision of emergency clinical alarms ………………………………………………………………………….28
6.6 (*) Provision of emergency operating alarms …………………………………………………………………28
7 Pipeline distribution systems ………………………………………………………………………………………..28
7.1 Mechanical resistance …………………………………………………………………………………………………..28
7.2 Distribution pressure …………………………………………………………………………………………………….28
7.3 Low-pressure hose assemblies and low-pressure flexible connections ………………………….29
7.4 Double-stage pipeline distribution systems …………………………………………………………………..30
8 Shut-off valves ………………………………………………………………………………………………………………30
8.1 General …………………………………………………………………………………………………………………………30
8.2 Service shut-off valves ………………………………………………………………………………………………….31
8.3 Area shut-off valves ………………………………………………………………………………………………………31
9 Terminal units, gas-specific connectors, medical supply units, pressure regulators and
pressure gauges ……………………………………………………………………………………………………………32
10 Marking and colour coding ……………………………………………………………………………………………33
10.1 Marking ……………………………………………………………………………………………………………………….. 33
10.2 Colour coding ……………………………………………………………………………………………………………… 33
11 Pipeline installation ……………………………………………………………………………………………………… 33
11.1 General ……………………………………………………………………………………………………………………….. 33
11.2 Pipeline supports …………………………………………………………………………………………………………. 34
11.3 Pipeline joints ……………………………………………………………………………………………………………… 35
11.4 Extensions and modifications of existing pipeline systems ………………………………………….. 35
12 Testing, commissioning and certification …………………………………………………………………….. 35
12.1 General ……………………………………………………………………………………………………………………….. 35
12.2 General requirements for tests …………………………………………………………………………………….. 36
12.3 Inspections and checks before concealment ………………………………………………………………… 36
12.4 Tests, checks and procedures before use of the system ………………………………………………. 36
12.5 Requirements for inspections and checks before concealment …………………………………….. 37
12.6 Requirements for tests, checks and procedures before use of the system ……………………. 37
12.7 Certification of the systems …………………………………………………………………………………………. 42
13 Information to be supplied by the manufacturer ……………………………………………………………. 43
13.1 General ……………………………………………………………………………………………………………………….. 43
13.2 Instructions for use ……………………………………………………………………………………………………… 43
13.3 Operational management information …………………………………………………………………………… 44
13.4 “As-installed” drawings ……………………………………………………………………………………………….. 44
13.5 Electrical diagrams ………………………………………………………………………………………………………. 44
Annex A (informative) Schematic representations of typical supply systems and area distribution
systems ………………………………………………………………………………………………………………………. 45
Annex B (informative) Guidelines for location of cylinder manifolds, cylinder storage areas and
stationary vessels for cryogenic or non-cryogenic liquids ……………………………………………. 68
Annex C (informative) Example of procedure for testing and commissioning ……………………………….. 69
Annex D (informative) Typical forms for certification of the medical gas pipeline system ……………… 81
Annex E (informative) Temperature and pressure relationships …………………………………………………. 111
Annex F (informative) Risk management checklist …………………………………………………………………….. 113
Annex G (informative) Operational management ………………………………………………………………………… 126
Annex H (informative) Rationale ………………………………………………………………………………………………… 144
Bibliography ……………………………………………………………………………………………………………………………… 146
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical devices ……………………………………… 148