| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 4<\/td>\n | European foreword Endorsement notice <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93\/42\/EEC on Medical devices Table ZA.1\u2014 Correspondence between this European Standard and Directive 93\/42\/EEC, Medical devices <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 1\t(*) Scope <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 2\tNormative references <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 3\tTerms and definitions <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 4\tGeneral requirements 4.1\t(*) Safety <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 4.2\t(*) Alternative construction 4.3\tMaterials <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 4.4\tSystem design 4.4.1\tGeneral 4.4.2\tExtensions and modifications of existing pipeline systems <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 5\tSupply systems 5.1\tSystem components 5.2\tGeneral requirements 5.2.1\tCapacity and storage 5.2.2\tContinuity of supply <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 5.2.3\tPrimary source of supply 5.2.4\tSecondary source of supply 5.2.5\tReserve source(s) of supply <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 5.2.6\tMeans of pressure relief 5.2.7\tMaintenance supply assembly <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 5.2.8\tPressure regulators 5.2.9\t(*)Ozone Sterilizers 5.3\tSupply systems with cylinders, cylinder bundles or high-pressure reservoir(s) 5.4\tSupply systems with cryogenic or non-cryogenic vessels <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 5.5\tSupply systems for air 5.5.1\tGeneral requirements <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 5.5.2\tSupply systems with air compressor(s) <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | 5.5.3\tSupply systems with proportioning unit(s) <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | 5.6\tSupply systems with oxygen concentrator(s) 5.6.1\tGeneral requirements 5.6.2\tPrimary source of supply 5.6.3\tSecondary source of supply <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | 5.6.4\tReserve source of supply 5.6.5\tSpecifications for oxygen 93 <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | 5.6.6\tOxygen concentrator unit 5.6.7\tOxygen 93 reservoirs 5.6.8\tOxygen analysers <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | 5.6.9\tLocal filling of permanently attached high-pressure reservoir(s), acting as reserve source of supply <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | 5.7\tSupply systems for vacuum <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | 5.8\tLocation of supply systems 5.9\tLocation of cylinder manifolds <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | 5.10\tLocation of stationary cryogenic vessels 6\tMonitoring and alarm systems 6.1\tGeneral 6.2\tInstallation requirements <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | 6.3\tMonitoring and alarm signals 6.3.1\tGeneral 6.3.2\tAuditory signals 6.3.3\tVisual signals 6.3.4\tEmergency and operating alarm characteristics <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | 6.3.5\tInformation signals 6.3.6\tRemote alarm extensions 6.4\tProvision of operating alarms <\/td>\n<\/tr>\n | ||||||
| 44<\/td>\n | 6.5\tProvision of emergency clinical alarms 6.6\t(*) Provision of emergency operating alarms <\/td>\n<\/tr>\n | ||||||
| 45<\/td>\n | 7\tPipeline distribution systems 7.1\tMechanical resistance 7.2\tDistribution pressure <\/td>\n<\/tr>\n | ||||||
| 46<\/td>\n | 7.3\tLow-pressure hose assemblies and low-pressure flexible connections <\/td>\n<\/tr>\n | ||||||
| 47<\/td>\n | 7.4\tDouble-stage pipeline distribution systems 8\tShut-off valves 8.1\tGeneral <\/td>\n<\/tr>\n | ||||||
| 48<\/td>\n | 8.2\tService shut-off valves 8.3\tArea shut-off valves <\/td>\n<\/tr>\n | ||||||
| 50<\/td>\n | 9\tTerminal units, gas-specific connectors, medical supply units, pressure regulators and pressure gauges 10\tMarking and colour coding 10.1\tMarking 10.2\tColour coding <\/td>\n<\/tr>\n | ||||||
| 51<\/td>\n | 11\tPipeline installation 11.1\tGeneral <\/td>\n<\/tr>\n | ||||||
| 52<\/td>\n | 11.2\tPipeline supports 11.3\tPipeline joints <\/td>\n<\/tr>\n | ||||||
| 53<\/td>\n | 11.4\tExtensions and modifications of existing pipeline systems 12\tTesting and commissioning 12.1\tGeneral <\/td>\n<\/tr>\n | ||||||
| 54<\/td>\n | 12.2\tGeneral requirements for tests 12.3\tInspections and checks before concealment 12.4\tTests, checks and procedures before use of the system <\/td>\n<\/tr>\n | ||||||
| 55<\/td>\n | 12.5\tRequirements for inspections and checks before concealment 12.5.1\tInspection of marking and pipeline supports 12.5.2\tCheck for compliance with design specifications 12.6\tRequirements for tests, checks and procedures before use of the system 12.6.1\tGeneral <\/td>\n<\/tr>\n | ||||||
| 57<\/td>\n | 12.6.2\t(*) Tests of area shut-off valves for leakage and closure and checks for correct zoning and correct identification 12.6.3\tTest for cross-connection <\/td>\n<\/tr>\n | ||||||
| 58<\/td>\n | 12.6.4\tTest for obstruction and flow <\/td>\n<\/tr>\n | ||||||
| 59<\/td>\n | 12.6.5\tChecks of terminal units and NIST, DISS or SIS connectors for mechanical function, gas specificity and identification 12.6.6\tTests or checks of system performance 12.6.7\t(*) Tests of pressure-relief valves <\/td>\n<\/tr>\n | ||||||
| 60<\/td>\n | 12.6.8\tTests of all sources of supply 12.6.9\tTests of monitoring and alarm systems 12.6.10\tTest for particulate contamination of pipeline distribution systems <\/td>\n<\/tr>\n | ||||||
| 61<\/td>\n | 12.6.11\tTests of the quality of medical air produced by supply systems with air compressor(s) 12.6.12\tTests of the quality of air for driving surgical tools produced by supply systems with air compressor(s) 12.6.13\tTests of the quality of medical air produced by supply systems with proportioning unit(s) 12.6.14\tTests of the quality of oxygen 93 produced by supply systems with oxygen concentrator(s) 12.6.15\tFilling with specific gas 12.6.16\tTests of gas identity <\/td>\n<\/tr>\n | ||||||
| 62<\/td>\n | 12.6.17\tVerification of restart after power supply failure 12.7\tStatement of compliance to this part of ISO\u00a07396 13\tInformation to be supplied by the manufacturer 13.1\tGeneral 13.2\tInstructions for installation 13.3\tInstructions for use <\/td>\n<\/tr>\n | ||||||
| 63<\/td>\n | 13.4\tOperational management information <\/td>\n<\/tr>\n | ||||||
| 64<\/td>\n | 13.5\t\u201cAs-installed\u201d drawings 13.6\tElectrical diagrams <\/td>\n<\/tr>\n | ||||||
| 65<\/td>\n | Annex\u00a0A (informative) Schematic representations of typical supply systems and area distribution systems <\/td>\n<\/tr>\n | ||||||
| 96<\/td>\n | Annex B (informative) Guidelines for location of cylinder manifolds, cylinder storage areas and stationary vessels for cryogenic or non-cryogenic liquids <\/td>\n<\/tr>\n | ||||||
| 97<\/td>\n | Annex C (informative) Example of procedure for testing and commissioning <\/td>\n<\/tr>\n | ||||||
| 110<\/td>\n | Annex D (informative) Typical forms for documenting compliance of the pipeline systems for compressed medical gas and vacuum <\/td>\n<\/tr>\n | ||||||
| 140<\/td>\n | Annex E (informative) Temperature and pressure relationships <\/td>\n<\/tr>\n | ||||||
| 142<\/td>\n | Annex\u00a0F (informative) Risk management checklist <\/td>\n<\/tr>\n | ||||||
| 159<\/td>\n | Annex G (informative) Operational management <\/td>\n<\/tr>\n | ||||||
| 179<\/td>\n | Annex\u00a0H (informative) Rationale <\/td>\n<\/tr>\n | ||||||
| 182<\/td>\n | Annex\u00a0I (informative) Rationale for compressor hazards <\/td>\n<\/tr>\n | ||||||
| 183<\/td>\n | Annex\u00a0J (informative) Considerations for implementation and use of oxygen 93 <\/td>\n<\/tr>\n | ||||||
| 185<\/td>\n | Annex K (informative) Manufacture of medical gases on site, Responsibility for medical gas quality <\/td>\n<\/tr>\n | ||||||
| 188<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Medical gas pipeline systems – Pipeline systems for compressed medical gases and vacuum<\/b><\/p>\n |