BS EN ISO 10524-1:2019
$167.15
Pressure regulators for use with medical gases – Pressure regulators and pressure regulators with flow-metering devices
| Published By | Publication Date | Number of Pages |
| BSI | 2019 | 42 |
This document specifies the design, construction, type testing, and marking requirements for pressure regulators (as defined in 3.18) intended for the administration of medical gases and their mixtures 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 pressure regulators:
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intended to be connected to cylinders by the operator;
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with integral flow-metering devices intended to be connected to cylinders by the operator;
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that are an integral part of medical equipment (e.g. anaesthetic workstations, lung ventilators, resuscitators).
A pressure regulator can be provided with pressure outlet or flow outlet, and can be adjustable or pre-set.
pressure regulators are intended to be fitted to refillable cylinders with a working pressure up to 30 000 kPa ( 300 bar) and can be provided with devices which control and measure the flow of the medical gas delivered.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | National foreword |
| 4 | European foreword |
| 7 | Foreword |
| 8 | Introduction |
| 9 | 1 Scope 2 Normative references |
| 10 | 3 Terms and definitions |
| 12 | 4 Nomenclature 5 General requirements 5.1 Safety 5.2 Usability 5.3 Alternative construction 5.4 Materials |
| 13 | 6 Design requirements 6.1 General |
| 14 | 6.2 Indicator for cylinder pressure or cylinder content 6.2.1 General 6.2.2 Pressure gauges, pressure indicators, and flowgauges 6.3 Integrated electronic device 6.4 Connections 6.4.1 Inlet connector |
| 15 | 6.4.2 Outlet connectors 6.5 * Requirements for outlet pressure 6.5.1 Pressure outlet |
| 16 | 6.5.2 Flow outlet 6.6 Flow-metering device 6.7 Flow control and indication 6.8 Pressure-adjusting device |
| 17 | 6.9 * Filtration 6.10 * Pressure-relief device 6.11 Leakage |
| 18 | 6.12 Mechanical strength 6.12.1 Resistance of the high-pressure side 6.12.2 Resistance of the low-pressure side to pneumatic pressure 6.12.3 Resistance of the low-pressure side to inlet pressure, P1 6.13 * Resistance to ignition 6.14 Requirements for pressure regulators with flowmeters 6.14.1 Calibration 6.14.2 Accuracy of flow |
| 19 | 6.14.3 Stability of flow 6.14.4 Legibility 6.14.5 Flow control device 6.15 Requirements for PRESSURE REGULATORS fitted with flowgauges 6.15.1 Calibration 6.15.2 Accuracy of flow 6.15.3 Stability of flow |
| 20 | 6.16 Requirements for pressure regulators fitted with fixed orifices 6.16.1 Stability and accuracy of flow 6.16.2 * Flow setting torque 6.16.3 Removal of a fixed orifice 6.16.4 Legibility 6.17 Endurance 6.17.1 Flow selector |
| 21 | 6.17.2 Pressure regulator 7 Construction requirements 7.1 * Cleanliness 7.2 Lubricants 7.3 Loosening torques |
| 22 | 8 Test methods for type tests 8.1 General conditions 8.1.1 General 8.1.2 Ambient conditions 8.1.3 Test gas 8.1.4 Reference conditions 8.2 Test schedule |
| 24 | 8.3 Test methods for outlet pressure 8.3.1 Test equipment |
| 25 | 8.3.2 Test methods for determining outlet pressure limits for a pressure regulator fitted with a pressure outlet |
| 26 | 8.3.3 Test method for determining the outlet pressure limit for a pressure regulator fitted with a flow outlet 8.4 Test method for a pressure-relief device 8.5 Test methods for leakage 8.5.1 External leakage |
| 27 | 8.5.2 Internal leakage 8.6 Test method for mechanical strength 8.6.1 Test method for the high-pressure side 8.6.2 Test method for resistance of the low-pressure side to pneumatic pressure 8.6.3 Test method for the resistance of the low pressure side to P1 |
| 28 | 8.7 Test method for resistance to ignition 8.7.1 General 8.7.2 Test procedure for adjustable and pre-set pressure regulators 8.8 Test method for accuracy of flow of pressure regulators fitted with flowmeters or flowgauges 8.9 Test method for the stability of flow of pressure regulator fitted with flowmeters or flowgauges |
| 29 | 8.10 Test method for stability and accuracy of flow of pressure regulators fitted with fixed orifices 8.11 Test method for flow setting and loosening torques 8.11.1 General 8.11.2 Test method for verifying no stable position between two settings 8.12 Test method for durability of markings and colour coding 8.13 *Flow selector endurance test |
| 30 | 8.14 Pressure regulator endurance test 9 Marking, colour coding, and packaging 9.1 Marking |
| 32 | 9.2 Colour coding 9.3 Packaging 10 Information to be supplied by the manufacturer |
| 34 | Annex A (informative) Rationale |
| 39 | Annex B (informative) Reported regional and national deviations of colour coding and nomenclature for medical gases |
| 41 | Bibliography |
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