BS EN ISO 7396-1:2016
$215.11
Medical gas pipeline systems – Pipeline systems for compressed medical gases and vacuum
| Published By | Publication Date | Number of Pages |
| BSI | 2016 | 194 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 4 | European foreword Endorsement notice |
| 5 | Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical devices Table ZA.1— Correspondence between this European Standard and Directive 93/42/EEC, Medical devices |
| 10 | Foreword |
| 11 | Introduction |
| 13 | 1 (*) Scope |
| 14 | 2 Normative references |
| 15 | 3 Terms and definitions |
| 21 | 4 General requirements 4.1 (*) Safety |
| 22 | 4.2 (*) Alternative construction 4.3 Materials |
| 24 | 4.4 System design 4.4.1 General 4.4.2 Extensions and modifications of existing pipeline systems |
| 25 | 5 Supply systems 5.1 System components 5.2 General requirements 5.2.1 Capacity and storage 5.2.2 Continuity of supply |
| 26 | 5.2.3 Primary source of supply 5.2.4 Secondary source of supply 5.2.5 Reserve source(s) of supply |
| 27 | 5.2.6 Means of pressure relief 5.2.7 Maintenance supply assembly |
| 28 | 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 |
| 29 | 5.5 Supply systems for air 5.5.1 General requirements |
| 30 | 5.5.2 Supply systems with air compressor(s) |
| 33 | 5.5.3 Supply systems with proportioning unit(s) |
| 35 | 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 |
| 36 | 5.6.4 Reserve source of supply 5.6.5 Specifications for oxygen 93 |
| 37 | 5.6.6 Oxygen concentrator unit 5.6.7 Oxygen 93 reservoirs 5.6.8 Oxygen analysers |
| 38 | 5.6.9 Local filling of permanently attached high-pressure reservoir(s), acting as reserve source of supply |
| 39 | 5.7 Supply systems for vacuum |
| 40 | 5.8 Location of supply systems 5.9 Location of cylinder manifolds |
| 41 | 5.10 Location of stationary cryogenic vessels 6 Monitoring and alarm systems 6.1 General 6.2 Installation requirements |
| 42 | 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 |
| 43 | 6.3.5 Information signals 6.3.6 Remote alarm extensions 6.4 Provision of operating alarms |
| 44 | 6.5 Provision of emergency clinical alarms 6.6 (*) Provision of emergency operating alarms |
| 45 | 7 Pipeline distribution systems 7.1 Mechanical resistance 7.2 Distribution pressure |
| 46 | 7.3 Low-pressure hose assemblies and low-pressure flexible connections |
| 47 | 7.4 Double-stage pipeline distribution systems 8 Shut-off valves 8.1 General |
| 48 | 8.2 Service shut-off valves 8.3 Area shut-off valves |
| 50 | 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 |
| 51 | 11 Pipeline installation 11.1 General |
| 52 | 11.2 Pipeline supports 11.3 Pipeline joints |
| 53 | 11.4 Extensions and modifications of existing pipeline systems 12 Testing and commissioning 12.1 General |
| 54 | 12.2 General requirements for tests 12.3 Inspections and checks before concealment 12.4 Tests, checks and procedures before use of the system |
| 55 | 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 |
| 57 | 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 |
| 58 | 12.6.4 Test for obstruction and flow |
| 59 | 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 |
| 60 | 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 |
| 61 | 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 |
| 62 | 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 |
| 63 | 13.4 Operational management information |
| 64 | 13.5 “As-installed” drawings 13.6 Electrical diagrams |
| 65 | Annex A (informative) Schematic representations of typical supply systems and area distribution systems |
| 96 | Annex B (informative) Guidelines for location of cylinder manifolds, cylinder storage areas and stationary vessels for cryogenic or non-cryogenic liquids |
| 97 | Annex C (informative) Example of procedure for testing and commissioning |
| 110 | Annex D (informative) Typical forms for documenting compliance of the pipeline systems for compressed medical gas and vacuum |
| 140 | Annex E (informative) Temperature and pressure relationships |
| 142 | Annex F (informative) Risk management checklist |
| 159 | Annex G (informative) Operational management |
| 179 | Annex H (informative) Rationale |
| 182 | Annex I (informative) Rationale for compressor hazards |
| 183 | Annex J (informative) Considerations for implementation and use of oxygen 93 |
| 185 | Annex K (informative) Manufacture of medical gases on site, Responsibility for medical gas quality |
| 188 | Bibliography |
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