ISO 10524-3:2019
Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with cylinder valves (VIPRs)
This document specifies design, type testing, and marking requirements for cylinder valves with integrated pressure regulators [as defined in 3.26 and referred to hereafter as valves with integrated pressure regulators (VIPRs)] intended for the administration of medical gases in the treatment, management, diagnostic evaluation and care of patients or for gases used for driving surgical tools.
Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures.
This document applies to VIPRs mounted on refillable cylinders with a working pressure up to 30 000 kPa (300 bar) intended to be filled in cylinder filling facilities or on self-filling systems as used in homecare applications.
VIPRs covered by this document are pressure pre-set and provided with a pressure outlet and/or pre-set flow outlet(s).
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Foreword
Introduction
1 *Scope
2 Normative references
3 Terms and definitions
4 Nomenclature
5 General requirements
5.1 Safety
5.2 Usability
5.3 Materials
5.4 Alternative construction
6 Design requirements
6.1 *General
6.2 Integrated electronic device
6.3 Filling port
6.4 Connections
6.4.1 valve inlet connection
6.4.2 Outlet connectors
6.5 *Requirements for outlet pressure
6.5.1 Pressure outlet
6.5.2 Flow outlet
6.6 Cylinder pressure or cylinder content indicator
6.6.1 Pressure gauges and cylinder content indicators
6.7 Flow selector
6.8 Filtration
6.9 Main shut-off
6.10 Residual pressure device
6.11 *Pressure-relief device
6.12 Leakage
6.13 Mechanical strength
6.13.1 Resistance of the high-pressure side
6.13.2 Resistance of the low-pressure side to excessive pressure
6.13.3 Resistance of the low-pressure side to P1
6.13.4 Impact and drop tests
6.14 *Resistance to ignition
6.15 Requirements for VIPR fitted with fixed orifices
6.15.1 Stability and accuracy of flow
6.15.2 *Flow setting torque
6.15.3 Removal of a fixed orifice
6.15.4 Legibility
6.16 Endurance
6.16.1 flow selector
6.16.2 Non-return valve fitted to the filling port
6.16.3 Pressure regulator
7 Construction requirements
7.1 *Cleanliness
7.2 Lubricants
7.3 Loosening torques
8 Test methods for non-gas specific type tests
8.1 General conditions
8.1.1 Ambient conditions
8.1.2 Test gas
8.1.3 Reference conditions
8.2 Test schedule
8.3 Test methods for outlet pressure
8.3.1 Purpose
8.3.2 Test equipment
8.3.3 Test methods for determining outlet pressure limits for VIPRs fitted with a pressure outlet
8.3.4 Test method for determining outlet pressure limits for a VIPR fitted with a flow outlet
8.4 Test method for pressure-relief device
8.4.1 Purpose
8.4.2 Test procedure
8.5 Test methods for leakage
8.5.1 Purpose
8.5.2 Test procedure
8.6 Test method for mechanical strength
8.6.1 Purpose
8.6.2 Test procedure
8.7 Test method for resistance to ignition
8.7.1 Purpose
8.7.2 General
8.7.3 Test procedure
8.8 Test methods for the stability and accuracy of flow of VIPRs fitted with fixed orifices
8.8.1 Purpose
8.8.2 Test procedure
8.9 Test method for flow setting and loosening torques
8.9.1 Purpose
8.9.2 Test procedure
8.10 Test for integrity of the filling port non-return valve under high flow condition
8.10.1 Purpose
8.10.2 Test procedure
8.11 Test method for durability of markings and colour coding
8.11.1 Purpose
8.11.2 Test procedure
8.12 Flow selector endurance test
8.12.1 Purpose
8.12.2 Test procedure
8.13 filling port non-return valve endurance test
8.13.1 Purpose
8.13.2 Test procedure
8.14 pressure regulator endurance test
8.14.1 Purpose
8.14.2 Test procedure
9 *Gas-specific type tests
9.1 Purpose
9.2 Apparatus
9.3 General test conditions
9.3.1 Test conditions
9.4 Test procedure
9.4.1 Test method for determining outlet pressure limits for a VIPR fitted with a pressure outlet
9.4.2 Test method for stability and accuracy of flow of a VIPR fitted with fixed orifices
9.4.3 Test method for residual pressure device
10 Marking, colour coding and packaging
10.1 Marking
10.2 Colour coding
10.3 Packaging
11 *Information to be supplied by the manufacturer
Annex A (informative) Example of VIPRs
Annex B (informative) Rationale
Annex C (informative) Reported regional and national deviations of colour coding and nomenclature for medical gases
Bibliography
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Foreword
Introduction
1 *Scope
2 Normative references
3 Terms and definitions
4 Nomenclature
5 General requirements
5.1 Safety
5.2 Usability
5.3 Materials
5.4 Alternative construction
6 Design requirements
6.1 *General
6.2 Integrated electronic device
6.3 Filling port
6.4 Connections
6.4.1 valve inlet connection
6.4.2 Outlet connectors
6.5 *Requirements for outlet pressure
6.5.1 Pressure outlet
6.5.2 Flow outlet
6.6 Cylinder pressure or cylinder content indicator
6.6.1 Pressure gauges and cylinder content indicators
6.7 Flow selector
6.8 Filtration
6.9 Main shut-off
6.10 Residual pressure device
6.11 *Pressure-relief device
6.12 Leakage
6.13 Mechanical strength
6.13.1 Resistance of the high-pressure side
6.13.2 Resistance of the low-pressure side to excessive pressure
6.13.3 Resistance of the low-pressure side to P1
6.13.4 Impact and drop tests
6.14 *Resistance to ignition
6.15 Requirements for VIPR fitted with fixed orifices
6.15.1 Stability and accuracy of flow
6.15.2 *Flow setting torque
6.15.3 Removal of a fixed orifice
6.15.4 Legibility
6.16 Endurance
6.16.1 flow selector
6.16.2 Non-return valve fitted to the filling port
6.16.3 Pressure regulator
7 Construction requirements
7.1 *Cleanliness
7.2 Lubricants
7.3 Loosening torques
8 Test methods for non-gas specific type tests
8.1 General conditions
8.1.1 Ambient conditions
8.1.2 Test gas
8.1.3 Reference conditions
8.2 Test schedule
8.3 Test methods for outlet pressure
8.3.1 Purpose
8.3.2 Test equipment
8.3.3 Test methods for determining outlet pressure limits for VIPRs fitted with a pressure outlet
8.3.4 Test method for determining outlet pressure limits for a VIPR fitted with a flow outlet
8.4 Test method for pressure-relief device
8.4.1 Purpose
8.4.2 Test procedure
8.5 Test methods for leakage
8.5.1 Purpose
8.5.2 Test procedure
8.6 Test method for mechanical strength
8.6.1 Purpose
8.6.2 Test procedure
8.7 Test method for resistance to ignition
8.7.1 Purpose
8.7.2 General
8.7.3 Test procedure
8.8 Test methods for the stability and accuracy of flow of VIPRs fitted with fixed orifices
8.8.1 Purpose
8.8.2 Test procedure
8.9 Test method for flow setting and loosening torques
8.9.1 Purpose
8.9.2 Test procedure
8.10 Test for integrity of the filling port non-return valve under high flow condition
8.10.1 Purpose
8.10.2 Test procedure
8.11 Test method for durability of markings and colour coding
8.11.1 Purpose
8.11.2 Test procedure
8.12 Flow selector endurance test
8.12.1 Purpose
8.12.2 Test procedure
8.13 filling port non-return valve endurance test
8.13.1 Purpose
8.13.2 Test procedure
8.14 pressure regulator endurance test
8.14.1 Purpose
8.14.2 Test procedure
9 *Gas-specific type tests
9.1 Purpose
9.2 Apparatus
9.3 General test conditions
9.3.1 Test conditions
9.4 Test procedure
9.4.1 Test method for determining outlet pressure limits for a VIPR fitted with a pressure outlet
9.4.2 Test method for stability and accuracy of flow of a VIPR fitted with fixed orifices
9.4.3 Test method for residual pressure device
10 Marking, colour coding and packaging
10.1 Marking
10.2 Colour coding
10.3 Packaging
11 *Information to be supplied by the manufacturer
Annex A (informative) Example of VIPRs
Annex B (informative) Rationale
Annex C (informative) Reported regional and national deviations of colour coding and nomenclature for medical gases
Bibliography