1、September 2008DEUTSCHE NORM English price group 17No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.10; 23.060.40
2、!$Qf:“1466723www.din.deDDIN EN ISO 10524-4Pressure regulators for use with medical gases Part 4: Low-pressure regulators (ISO 10524-4:2008)English version of DIN EN ISO 10524-4:2008-09Druckminderer zur Verwendung mit medizinischen Gasen Teil 4: Niederdruckminderer (ISO 10524-4:2008)Englische Fassung
3、 DIN EN ISO 10524-4:2008-09www.beuth.deDocument comprises 40 pagesDIN EN ISO 10524-4:2008-09 2 National foreword This standard has been published in accordance with a decision taken by CEN/TC 215 “Respiratory and anaesthetic equipment” (Secretariat: BSI, United Kingdom) to adopt, without alteration,
4、 International Standard ISO 10524-4:2008 as a European Standard. ISO 10524-4:2008 has been prepared by Technical Committee ISO/TC 121. The responsible German body involved in its preparation was the Normenausschuss Rettungsdienst und Krankenhaus (Rescue Services and Hospital Standards Committee), Te
5、chnical Committee NA 053-03-06 AA Zentrale Gasversorgungsanlagen. The DIN Standards corresponding to the International Standards referred to in clause 2 and in the bibliography of the EN are as follows: ISO 4135 DIN EN ISO 4135 ISO 5359 DIN EN ISO 5359 ISO 9170-1 DIN EN ISO 9170-1 ISO 10524-1 DIN EN
6、 ISO 10524-1 ISO 10524-3 DIN EN ISO 10524-3 ISO 11114-3 DIN EN ISO 11114-3 ISO 14971 DIN EN ISO 14971 ISO 15001 DIN EN ISO 15001 ISO 15002 DIN EN ISO 15002 IEC 60601-1 DIN EN 60601-1 (VDE 0750-1) DIN EN ISO 10524 consists of the following parts, under the general title Pressure regulators for use wi
7、th medical gases: Part 1: Pressure regulators and pressure regulators with flow-metering devices Part 2: Manifold and line pressure regulators Part 3: Pressure regulators integrated with cylinder valves Part 4: Low-pressure regulators National Annex NA (informative) Bibliography DIN EN 60601-1 (VDE
8、0750-1), Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN EN ISO 4135, Anaesthetic and respiratory equipment Vocabulary DIN EN ISO 5359, Low-pressure hose assemblies for use with medical gases DIN EN ISO 10524-4:2008-09 3 DIN EN ISO 9170-1, Ter
9、minal units for medical gas pipeline systems Part 1: Terminal units for use with compressed medical gases and vacuum DIN EN ISO 10524-1, Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices DIN EN ISO 10524-3, Pressure regulato
10、rs for use with medical gases Part 3: Pressure regulators integrated with cylinder valves DIN EN ISO 11114-3, Compatibility of transportable gas cylinder and valve materials with gas content Part 3: Autogenous ignition test in oxygen atmosphere DIN EN ISO 14971, Medical devices Application of risk m
11、anagement to medical devices DIN EN ISO 15001, Anaesthetic and respiratory equipment Compatibility with oxygen DIN EN ISO 15002, Flow-metering devices for connection to terminal units of medical gas pipeline systems DIN EN ISO 10524-4:2008-09 4 This page is intentionally blank EUROPEAN STANDARD NORM
12、E EUROPENNE EUROPISCHE NORM EN ISO 10524-4 June 2008 ICS 11.040.10 Supersedes EN 738-4:1998 English Version Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008) Dtendeurs pour lutilisation avec les gaz mdicaux - Partie 4: Dtendeurs basse pression (ISO 1
13、0524-4:2008) Druckminderer zur Verwendung mit medizinischen Gasen -Teil 4: Niederdruckminderer (ISO 10524-4:2008) This European Standard was approved by CEN on 29 May 2008. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this Europe
14、an Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member. This European Standard exists in three official versions (English
15、, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, C
16、yprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION
17、COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2008 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10524-4:2008: E2 DIN EN ISO 10524-4:2008-09 EN ISO 10524-
18、4:2008 (E) Contents Page Foreword3 Introduction .4 1 Scope 5 2 * Normative references6 3 Terms and definitions .6 4 Nomenclature.8 5 General requirements8 5.1 Safety 8 5.2 Alternative construction .8 5.3 Materials .9 5.4 Design requirements .9 5.5 Constructional requirements. 16 6 Test methods. 16 6
19、.1 General. 16 6.2 Test conditions . 17 6.3 Test method for outlet pressure 17 6.4 Test methods for leakage 18 6.5 Test method for mechanical strength 19 6.6 Test method for accuracy of flow of pressure regulators fitted with flowmeters or flowgauges 19 6.7 Test method for the stability of flow of p
20、ressure regulators fitted with flowmeters or flowgauges 19 6.8 Test method for stability and accuracy of flow of pressure regulators fitted with fixed orifices . 19 6.9 Test method for loosening torque 19 6.10 Test method for durability of markings and colour coding . 19 7 Marking, colour coding, pa
21、ckaging 20 7.1 Marking 20 7.2 Colour coding 21 7.3 Packaging 21 8 Information to be supplied by the manufacturer. 21 Annex A (informative) Typical examples of low-pressure regulators. 23 Annex B (informative) Rationale. 28 Annex C (informative) Reported regional and national deviations of colour cod
22、ing and nomenclature for medical gases. 30 Annex D (informative) Environmental aspects 32 Annex ZA (informative) Correspondence between this International Standard and Directive 93/42/EEC. 34 Bibliography. 36 Foreword This document (EN ISO 10524-4:2008) has been prepared by Technical Committee ISO/T
23、C 121 “Anaesthetic and respiratory equipment“ in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or b
24、y endorsement, at the latest by December 2008, and conflicting national standards shall be withdrawn at the latest by June 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for
25、identifying any or all such patent rights. This document supersedes EN 738-4:1998. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive(s). For relationship with EC Directi
26、ve(s), see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark,
27、Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 10524-4:2008 has been approved
28、by CEN as a EN ISO 10524-4:2008 without any modification. 3 DIN EN ISO 10524-4:2008-09 EN ISO 10524-4:2008 (E) -4Introduction A low-pressure regulator is used to reduce the pressure in a medical gas pipeline system to a lower pressure suitable for use with medical equipment or for delivery of gas di
29、rectly to a patient. These functions cover a range of inlet and outlet pressures and flows which require specific design characteristics. It is important that the operating characteristics of low-pressure regulators are appropriately specified for their intended use and then tested in a defined mann
30、er. A low-pressure regulator may be coupled to a device that controls the flow, such as a flow control valve or a fixed orifice. The flow can be indicated by a flowmeter or by a flowgauge. It is essential that regular inspection and maintenance are undertaken to ensure that low-pressure regulators c
31、ontinue to meet the requirements of this part of ISO 10524. This part of ISO 10524 pays particular attention to: safety (mechanical strength, leakage, safe relief of excess pressure and resistance to ignition); suitability of materials; gas specificity; accuracy; cleanliness; testing; marking; infor
32、mation supplied by the manufacturer. Annex B contains rationale statements for some of the requirements of this part of ISO 10524. The clauses and subclauses marked with an asterisk (*) after their number have corresponding rationale contained in Annex B, included to provide additional insight into
33、the reasoning that led to the requirements and recommendations that have been incorporated in this document. It is considered that knowledge of the reasons for the requirements will not only facilitate the proper application of this part of ISO 10524, but will expedite any subsequent revisions. 4 DI
34、N EN ISO 10524-4:2008-09 EN ISO 10524-4:2008 (E) 1 Scope 1.1 This part of ISO 10524 applies to the types of low-pressure regulators listed in 1.2 and intended to be used with the following medical gases in the treatment, management, diagnostic evaluation and care of patients: oxygen; nitrous oxide;
35、medical air; helium; carbon dioxide; xenon; specified mixtures of the gases listed above; air for driving surgical tools; nitrogen for driving surgical tools; oxygen-enriched air. 1.2 The types of low-pressure regulators covered by this part of ISO 10524 are as follows: a) low-pressure regulators in
36、tended to be connected to terminal units of medical gas pipeline systems complying with ISO 7396-1; b) low-pressure regulators with integral flow-metering devices intended to be connected to terminal units of medical gas pipeline systems complying with ISO 7396-1; c) low-pressure regulators intended
37、 to be connected to terminal units attached to pressure regulators complying with ISO 10524-1 or ISO 10524-3; d) operator-adjustable low-pressure regulators for air or nitrogen for driving surgical tools that are an integral part of a medical gas pipeline system complying with ISO 7396-1. 1.3 This p
38、art of ISO 10524 does not apply to low-pressure regulators integrated within anaesthetic and respiratory equipment. 5 DIN EN ISO 10524-4:2008-09 EN ISO 10524-4:2008 (E) 2 The following referenced documents are indispensable for the application of this document. For dated references, only the edition
39、 cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 5359, Low-pressure hose assemblies for use with medical gases ISO 7396-1, Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum ISO 91
40、70-1, Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed medical gases and vacuum ISO 10524-1, Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices ISO 10524-3, Pressure regulators fo
41、r use with medical gases Part 3: Pressure regulators integrated with cylinder valves ISO 11114-3:1997, Transportable gas cylinders Compatibility of cylinder and valve materials with gas contents Part 3: Autogenous ignition test in oxygen atmosphere ISO 14971:2007, Medical devices Application of risk
42、 management to medical devices ISO 15001:2003, Anaesthetic and respiratory equipment Compatibility with oxygen EN 837-1, Pressure gauges Part 1: Bourdon tube pressure gauges Dimensions, metrology, requirements and testing EN 1089-3:2004, Transportable gas cylinders Gas cylinder identification (exclu
43、ding LPG) Part 3: Colour coding EN 13544-2, Respiratory therapy equipment Part 2: Tubing and connectors 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 accuracy of flow difference between the indicated value and the actual value of the flow e
44、xpressed in percent 3.2 adjustable pressure regulator pressure regulator that is provided with a means of operator adjustment of the outlet pressure 3.3 flow outlet outlet intended to deliver a controlled flow of gas 3.4 flowgauge device that measures pressure and that is calibrated in units of flow
45、 NOTE The flowgauge does not measure flow. It indicates flow by measuring the pressure upstream of a fixed orifice. 6 * Normative references DIN EN ISO 10524-4:2008-09 EN ISO 10524-4:2008 (E) 3.5 flowmeter device that measures and indicates the flow of a specific gas or gas mixture 3.6 flow-metering
46、 device device fitted with an inlet connector and an outlet connector and that incorporates one of the following: a) a flowmeter with a flow control valve; b) a flowgauge and a fixed orifice with a flow control valve; c) one or more fixed orifices with a means of selection 3.7 gas-specific having ch
47、aracteristics that prevent connection between different gas services 3.8 gas-specific connection point that part of the terminal unit that is the receptor for a gas-specific probe 3.9 low pressure pressure of 2 000 kPa or less 3.10 maximum inlet pressure pmmaximum upstream pressure specified by the
48、manufacturer for which the pressure regulator is intended to be used 3.11 nominal outlet pressure p2nominal downstream pressure NOTE p2is specified by the manufacturer in the instructions for use for a pressure regulator with pressure outlet(s). 3.12 medical gas pipeline system complete system that
49、comprises a supply system, a monitoring and alarm system and a distribution system with terminal units at the points where medical gases or vacuum may be required 3.13 nipple that portion of a connector that is pushed into and secured within the bore (lumen) of a hose 3.14 orifice restriction of known cross section that delivers a constant flow of gas when supplied with gas at a constant upstream pressure NOTE An orifice does not provide an indication of flow. 3.15 pipeline distributio
