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