1、 DEUTSCHE NORM May 2006DIN EN ISO 10524-1 ICS 11.040.10; 23.060.40 Supersedes DIN EN 738-1:2002-07 Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006) English version of DIN EN ISO 10524-1:2006-05 Druckminde
2、rer zur Verwendung mit medizinischen Gasen Teil 1: Druckminderer und Druckminderer mit Durchflussmessgerten (ISO 10524-1:2006) Englische Fassung DIN EN ISO 10524-1:2006-05 Document comprises 39 pages No part of this standard may be reproduced without prior permission of DIN Deutsches Institut fr Nor
3、mung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany, has the exclusive right of sale for German Standards (DIN-Normen). English price group 17 www.din.de www.beuth.de !,nl“11.06 9757388DIN EN ISO 10524-1:2006-05 2 National foreword This standard has been prepared by Technical Committee ISO/
4、TC 121 Anaesthetic and respirators equipment in collaboration with Technical Committee CEN/TC 215 Respiratory and anaesthetic equipment. The responsible German body involved in its preparation was the Normenausschuss Rettungsdienst und Krankenhaus (Rescue Services and Hospital Standards Committee),
5、Technical Committee 053-03-06 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: IEC 60601-1 DIN EN 60601-1 (VDE 0750 Part 1) ISO 2503 DIN EN ISO 2503 ISO 4135 DIN EN ISO 4135 ISO 14
6、971 DIN EN ISO 14971 ISO 15001 DIN EN ISO 15001 Amendments This standard differs from DIN EN 738-1:2002-07 as follows: a) The scope has been extended to cover regulators for fitting to cylinders with nominal filling pressures up to 25 000 kPa. b) The gas mixtures NO/N2have been removed from the list
7、 of medical gases. c) A requirement has been added that aluminium or aluminium alloys shall not be used for components on the high pressure side of a pressure regulator. d) Requirements for the pressure-relief valve and pressure-regulator valve have been revised. e) Requirements for connectors and o
8、utlet pressures have been adapted to the European Standard on medical gas pipeline systems, which is currently under preparation. f) Performance requirements and test procedures have been revised. g) Requirements for information to be supplied by the manufacturer have been revised. h) Additions have
9、 been made to the informative Annex giving regional and national deviations of colour coding for medical gases. i) The standard has been editorially revised. Previous editions DIN EN 738-1: 1997-04, 2002-07 DIN EN ISO 10524-1:2006-05 3 National Annex NA (informative) Bibliography DIN EN 60601-1 (VDE
10、 0750 Part 1), Medical electrical equipment Part 1: General requirements for safety (IEC 60601-1:1988 + A1:1991 + A2:1995) DIN EN ISO 2503, Gas welding equipment Pressure regulators for gas cylinders used in welding, cutting and allied processes up to 300 bar (ISO 2503:1998) DIN EN ISO 4135, Anaesth
11、etic and respiratory equipment Vocabulary (ISO 4135:2001) DIN EN ISO 14971, Medical devices Application of risk management to medical devices (ISO 14971:2000) DIN EN ISO 15001, Anaesthetic and respiratory equipment Compatibility with oxygen (ISO 15001:2003) EUROPEAN STANDARD NORME EUROPENNE EUROPISC
12、HE NORM EN ISO 10524-1 February 2006 ICS 11.040.10 Supersedes EN 738-1:1997 English Version Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006) Dtendeurs pour lutilisation avec les gaz mdicaux - Partie 1:
13、Dtendeurs et dtendeurs dbitmtre intgr (ISO 10524-1:2006) Druckminderer zur Verwendung mit medizinischen Gasen -Teil 1: Druckminderer und Druckminderer mit Durchflussmessgerten (ISO 10524-1:2006) This European Standard was approved by CEN on 30 November 2005. CEN members are bound to comply with the
14、CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European 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 Central Secretariat or
15、to any CEN member. This European Standard exists in three official versions (English, 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 Central Secretariat has the same status as the official versio
16、ns. CEN members are the national standards bodies of Austria, Belgium, Cyprus, 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
17、, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. R
18、ef. No. EN ISO 10524-1:2006: EEN ISO 10524-1:2006 (E) 2 Foreword This document (EN ISO 10524-1:2006) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment”, the secretari
19、at 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 by endorsement, at the latest by August 2006, and conflicting national standards shall be withdrawn at the latest by August 2006. This document supersede
20、s EN 738-1:1997. 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 EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
21、 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
22、 Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 10524-1:2006 has been approved by CEN as EN ISO 10524-1:2006 without any modifications. EN ISO 10524-1:2006 (E)
23、 3 Contents Page Foreword .2 Introduction.4 1 Scope5 2 Normative references6 3 Terms and definitions .6 4 Nomenclature.8 5 General requirements .8 5.1 Safety8 5.2 Alternative construction .8 5.3 Materials .8 5.4 Design requirements.9 5.5 Constructional requirements .16 6 Test methods .16 6.1 General
24、 .16 6.2 Test methods for outlet pressure 17 6.3 Test method for pressure-relief valve .18 6.4 Test methods for leakage .18 6.5 Test method for mechanical strength .19 6.6 Test method for resistance to ignition19 6.7 Test method for accuracy of flow of pressure regulators fitted with flowmeters or f
25、lowgauges.20 6.8 Test method for the stability of flow of pressure regulators fitted with flowmeters or flowgauges.20 6.9 Test method for stability and accuracy of flow of pressure regulators fitted with fixed orifices20 6.10 Test method for flow setting and loosening torques 20 6.11 Test method for
26、 durability of markings and colour coding 20 7 Marking, colour coding, packaging.20 7.1 Marking.20 7.2 Colour coding 22 7.3 Packaging.22 8 Information to be supplied by the manufacturer .22 Annex A (informative) Typical examples of pressure regulators and pressure regulators with flow-metering devic
27、es .26 Annex B (informative) Rationale30 Annex C (informative) Reported regional and national deviations of colour coding and nomenclature for medical gases .32 Bibliography34 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42 EEC
28、concerning Medical Devices35 EN ISO 10524-1:2006 (E) 4 Introduction A pressure regulator is used to reduce high cylinder pressure to a lower pressure suitable for use with medical equipment or for delivery of gas directly to a patient. These functions cover a wide range of inlet and outlet pressures
29、 and flows which require specific design characteristics. It is important that the operating characteristics of the pressure regulators are specified and tested in a defined manner. A pressure regulator often has coupled to it a device which controls the flow, such as a flow control valve or a fixed
30、 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 pressure regulators continue to meet the requirements of this part of ISO 10524. This part of ISO 10524 pays particular attention to: use of sui
31、table materials; safety (mechanical strength, leakage, safe relief of excess pressure and resistance to ignition); gas specificity; cleanliness; type testing; marking; information supplied by the manufacturer. Annex B contains rationale statements for some of the requirements of this part of ISO 105
32、24. The clauses and subclauses marked with an asterix (*) after their number have corresponding rationale, contained in Annex B, included to provide additional insight into the reasoning that led to the requirements and recommendations that have been incorporated in this part of ISO 10524. It is con
33、sidered 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. EN ISO 10524-1:2006 (E) 5 1 Scope 1.1 This part of ISO 10524 is applicable to the types of pressure regulators listed in 1
34、.3 intended for the administration of the following medical gases in the treatment, management, diagnostic evaluation and care of patients: oxygen; nitrous oxide; air for breathing; helium; carbon dioxide; xenon; mixtures of the gases listed above; air for driving surgical tools; nitrogen for drivin
35、g surgical tools. 1.2* These pressure regulators are intended to be fitted to cylinders with nominal filling pressures up to 25 000 kPa at 15 C and can be provided with devices which control and measure the flow of the medical gas delivered. 1.3 The types of pressure regulators covered by this part
36、of ISO 10524 are as follows: a) pressure regulators intended to be connected to cylinders by the operator; b) pressure regulators with integral flow-metering devices intended to be connected to cylinders by the operator; c) pressure regulators that are an integral part of medical equipment (e.g. ana
37、esthetic workstations, lung ventilators, resuscitators). EN ISO 10524-1:2006 (E) 6 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the
38、 referenced document (including any amendments) applies. ISO 32:1977, Gas cylinders for medical use Marking for identification of content ISO 407:2004, Small medical gas cylinders Pin-index, yoke-type valve connections ISO 5145:2004, Cylinder valve outlets for gases and gas mixtures Selection and di
39、mensioning ISO 5359:2000, Low-pressure hose assemblies for use with medical gases ISO 9170-1:1999, Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed medical gases and vacuum ISO 14971:2000, Medical devices Application of risk management to medical devices
40、 ISO 15001:2003, Anaesthetic and respiratory equipment Compatibility with oxygen EN 837-1:1996, Pressure gauges Part 1: Bourdon tube pressure gauges Dimensions, metrology, requirements and testing EN 13544-2:2002, Respiratory therapy equipment Part 2: Tubing and connectors SS 01 91 02, Colour Atlas
41、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 expressed in percent 3.2 adjustable pressure regulator pressure regulator that is provided with a means o
42、f 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 NOTE The flowgauge does not measure flow. It indicates flow by measuring the pressure upstream of a fix
43、ed orifice. 3.5 flowmeter device that measures and indicates the flow of a specific gas or gas mixture 3.6 gas-specific connection point that part of the terminal unit that is the receptor for a gas-specific probe EN ISO 10524-1:2006 (E) 7 3.7 gas-specific having characteristics that prevent connect
44、ion between different gas services 3.8 nipple that portion of a connector that is pushed into and secured within the bore (lumen) of a hose 3.9 nominal inlet pressure p1upstream pressure specified by the manufacturer for which the pressure regulator is intended to be used NOTE For compressed gases (
45、e.g. oxygen) p1is related to the cylinder filling pressure at 15 C. 3.10 nominal outlet pressure p2nominal downstream pressure NOTE p2is specified by the manufacturer in the instructions for use. 3.11 orifice restriction of known cross-section that delivers a constant flow of gas when supplied with
46、gas at a constant upstream pressure NOTE An orifice does not provide an indication of flow. 3.12 preset pressure regulator pressure regulator that is not provided with a means of operator adjustment of the outlet pressure 3.13 pressure gauge device that measures and indicates pressure 3.14 pressure
47、outlet outlet intended to deliver gas at a controlled pressure 3.15 pressure regulator device that reduces the inlet pressure and maintains the set outlet pressure within specified limits 3.16 pressure-relief valve device intended to relieve excess pressure at a preset value 3.17 single fault condit
48、ion condition in which a single means for protection against a safety hazard in equipment is defective or a single external abnormal condition is present IEC 60601-1 EN ISO 10524-1:2006 (E) 8 4 Nomenclature Examples of pressure regulators with terminology are given in Annex A. 5 General requirements
49、 5.1 Safety Pressure regulators shall, when transported, stored, installed, operated in normal use and maintained according to the instructions of the manufacturer, cause no safety hazard which could be foreseen using risk management procedures in accordance with ISO 14971:2000 and which is connected with their intended application, in normal condition and in single fault condition. 5.2 Alternative construction Pressure regulators and components or parts thereof, using materials or having forms of
