PREN ISO 7396-1 : DRAFT 2004

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
   4.1 Safety
   4.2 R Alternative construction
   4.3 Materials
   4.4 System design
5 Supply systems
   5.1 System components
   5.2 General requirements
   5.3 Supply system with cylinders
   5.4 Supply systems with mobile or stationary cryogenic vessels
   5.5 Supply systems for air
   5.6 Supply systems for oxygen-enriched air
   5.7 Supply systems for vacuum
   5.8 Location of cylinder manifolds
   5.9 Location of stationary cryogenic vessels
   5.10 Location of vacuum pumps and air compressor systems
   5.11 R General requirements for supply systems
6 Monitoring and alarm systems
   6.1 General
   6.2 Installation requirements
   6.3 Monitoring and alarm signals
   6.4 Provision of operating alarms
   6.5 Provision of emergency clinical 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-storage pipeline distribution system
8 Shut-off values
   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
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 medical
        gas pipeline systems
12 Testing, commissioning and certification
   12.1 General
   12.2 General requirements for tests
   12.3 Tests and inspections after installation of pipeline
        distribution systems with at least the base blocks
        of all terminal units fitted but before concealment
   12.4 Tests and procedures after complete installation and
        before use of the system
   12.5 Requirements for tests and inspections after installation
        of pipeline distribution systems with at least the
        base blocks of all terminal units fitted but before
        concealment
   12.6 Requirements for tests and procedures after complete
        installation and before use of the system
   12.7 Certification of the systems
13 Information to be supplied by the manufacturer
   13.1 Instructions for use
   13.2 Operational Management Information
   13.3 "As-installed" drawings
   13.4 Electrical diagrams
Annex A (informative) Schematic representation of supply systems
        and area distributive systems
        A.1 General
Annex B (informative) Guidelines for location of cylinder manifolds
        and stationary vessels for cryogenic and or
        non-cryogenic liquids
        B.1 Location of cylinder manifolds
        B.2 Location of stationary vessels
Annex C (informative) Example of procedure for testing and
        commissioning
        C.1 General
        C.2 Tests and inspections after installation of pipeline
            distribution systems with at least the base blocks
            of all terminal units fitted but before concealment
        C.3 Tests and procedures after complete installation
            and before use of the system
Annex D (informative) Typical forms for certification of the
        medical gas pipeline system
        D.1 Form D.1 - Summary of tests
        D.2 Form D.2 - Tests for mechanical integrity, inspection
            of markings and supports
        D.3 Form D.3 - Tests for leakage
        D.4 Form D.4 - Check of design specification
        D.5 Form D.5 - Test for leakage from the compressed
            medical gas pipeline
        D.6 Form D.6 - Test for leakage from vacuum pipelines
        D.7 Form D.7 - Tests for leakage, closure, zoning and
            identification of area shut-off valves
        D.8 Form D.8 - Tests for cross-connections
        D.9 Form D.9 - Test for obstruction and flow, mechanical
            function, gas-specificity and identification of
            terminal units
        D.10 Form D.10 - Test for obstruction and flow, mechanical
             function, gas-specificity and identification of
             NIST or DISS connectors
        D.11 Form D.11 - Tests of system performance
        D.12 Form D.12 - Tests of pressure-relief valve
        D.13 Form D.13 - Tests of all sources of supply
        D.14 Form D.14 - Tests of monitoring and alarm systems
        D.15 Form D.15 - Test for particulate contamination
        D.16 Form D.16 - Test of quality of medical air produced
             by air compressor systems
        D.17 Form D.17 - Test of quality of air for driving surgical
             tools produced by air compressor systems
        D.18 Form D.18 - Test of quality of synthetic air produced
             by proportioning systems
        D.19 Form D.19 - Test of quality of oxygen-enriched air
             produced by oxygen concentrator system
        D.20 Form D.20 - Filling with specific gas
        D.21 Form D.21 - Test of gas identity
Annex E (informative) Temperature and pressure relationships
        E.1 Principle
        E.2 Example
Annex F (informative) Risk management - Risk assessment
        checklist
        F.1 General
        F.2 Risk management procedure
        F.3 Risk assessment checklist
Annex G (informative) Operational management
        G.1 Introduction
        G.2 Statutory requirements
        G.3 Functional responsibilities
        G.4 Operational Management Document
        G.5 Operational procedures
Annex H (informative) Rationale
Bibliography
Annex ZA (informative) Relationship between this European Standard
         and the Essential Requirements of EU Directive 93/42/EEC
         Medical Devices