DIN EN ISO 10524-2-2006 Pressure regulators for use with medical gases - Part 2 Manifold and line pressure regulators (ISO 10524-2 2005) English version of DIN EN ISO 10524-2 2006-.pdf

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1、 DEUTSCHE NORM July 2006DIN EN ISO 10524-2 ICS 11.040.10; 23.060.40 Supersedes DIN EN 738-2:1998-12 Pressure regulators for use with medical gases Part 2: Manifold and line pressure regulators (ISO 10524-2:2005) English version of DIN EN ISO 10524-2:2006-07 Druckminderer zur Verwendung mit medizinis

2、chen Gasen Teil 2: Hauptstellendruckregler und Leitungsdruckminderer (ISO 10524-2:2005) Englische Fassung DIN EN ISO 10524-2:2006-07 Document comprises 37 pages No part of this standard may be reproduced without prior permission of DIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH,

3、10772 Berlin, Germany, has the exclusive right of sale for German Standards (DIN-Normen). English price group 16 www.din.de www.beuth.de !,oy“11.06 9768694DIN EN ISO 10524-2:2006-07 2 National foreword This standard has been published in accordance with a decision taken by CEN/TC 215 Respiratory and

4、 anaesthetic equipment to adopt, without alteration, International Standard ISO 10524-2 as a European Standard. The responsible German body involved in its preparation was the Normenausschuss Rettungsdienst und Krankenhaus (Rescue Services and Hospital Standards Committee), Technical Committee 053-0

5、3-06 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 4126-7 DIN EN ISO 4126-7 ISO 4135 DIN EN ISO 4135 ISO 7291 DIN EN ISO 7291 IS

6、O 10079-3 DIN EN ISO 10079-3 ISO 10524-1 DIN EN ISO 10524-1 ISO 14971 DIN EN ISO 14971 ISO 15001 DIN EN ISO 15001 Amendments This standard differs from DIN EN 738-1998-12 as follows: a) The scope now covers manifold pressure regulators to be connected to cylinders with nominal filling pressures up t

7、o 25 000 kPA at 15 C and line pressure regulators for inlet pressures up to 3 000 kPA. b) The number of gases for which the pressure regulators are intended has been extended to include oxygen produced by an oxygen concentrator. c) The requirement that aluminium or aluminium alloys are not to be use

8、d for components of manifold pressure regulators whose surfaces come into contact with gas at cylinder pressure has been added. d) There is an additional requirement for connectors for a pressure gauge with a scale range greater than 4 000 kPa. e) Requirements for the pressure-adjusting device and r

9、egarding mechanical strength, including testing thereof, have been modified and/or added. f) Requirements for the functional and flow characteristics of manifold pressure regulators, and the testing of such, have been modified and/or added. g) Requirements regarding the nominal inlet pressure of man

10、ifold pressure regulators have been added. h) Requirements for and testing of the pressure relief valve of manifold pressure regulators have been modified. i) Requirements regarding leakage and outlet pressure variation limits, and the testing of such, for line pressure regulators have been newly sp

11、ecified. j) The testing of the mechanical strength of line pressure regulators has been modified. DIN EN ISO 10524-2:2006-07 3 k) As regards the cleanliness of manifold and line pressure regulators, the requirements of ISO 15001 are now to be met. l) The information to be supplied by the manufacture

12、r has been modified. m) An informative Annex covering regional and national deviations in the colour coding and nomenclature of medical gases is now included. n) The Annex regarding variations in colour coding at the national level has been deleted. o) The standard has been editorially revised. Prev

13、ious editions DIN EN 738-2: 1998-12 National Annex NA (informative) Bibliography DIN EN 60601-1 (VDE 0750 Part 1), Medical electrical equipment Part 1: General requirements for safety DIN EN ISO 4126-7, Safety devices for protection against excessive pressure Part 7: Common data DIN EN ISO 4135, Ana

14、esthetic and respiratory equipment Vocabulary DIN EN ISO 7291, Gas welding equipment Pressure regulators for manifold systems used in welding, cutting and allied processes up to 300 bar DIN EN ISO 10079-3, Medical suction equipment Part 3: Suction equipment powered from a vacuum or pressure source D

15、IN 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 14971, Medical devices Application of risk management to medical devices (ISO 14971:2000) DIN EN ISO 15001, Anaesthetic and respiratory equipmen

16、t Compatibility with oxygen (ISO 15001:2003) DIN EN ISO 10524-2:2006-07 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10524-2 April 2006 ICS 11.040.10 Supersedes EN 738-2:1998 English Version Pressure regulators for use with medical gases - Part 2: Manif

17、old and line pressure regulators (ISO 10524-2:2005) Dtendeurs pour lutilisation avec les gaz mdicaux - Partie 2: Dtendeurs de rampes et de canalisations (ISO 10524-2:2005) Druckminderer zur Verwendung mit medizinischen Gasen -Teil 2: Hauptstellendruckregler und Leitungsdruckminderer (ISO 10524-2:200

18、5) This European Standard was approved by CEN on 20 March 2006. CEN members are bound to comply with the 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 re

19、ferences concerning such national standards may be obtained on application to the Central Secretariat or 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

20、 into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithua

21、nia, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, 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 C

22、EN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10524-2:2006: EEN ISO 10524-2:2006 (E) 2 Foreword The text of ISO 10524-2:2005 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the In

23、ternational Organization for Standardization (ISO) and has been taken over as EN ISO 10524-2:2006 by 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 pub

24、lication of an identical text or by endorsement, at the latest by October 2006, and conflicting national standards shall be withdrawn at the latest by October 2006. This document supersedes EN 738-2: 1998. This document has been prepared under a mandate given to CEN by the European Commission and th

25、e 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 document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the follo

26、wing countries are bound to implement this European Standard: 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, Spai

27、n, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 10524-2:2005 has been approved by CEN as EN ISO 10524-2:2006 without any modifications. EN ISO 10524-2:2006 (E) 3 Contents Page Foreword .2 Introduction.4 1 Scope5 2 Normative references5 3 Terms and definitions .6 4 Symbo

28、ls8 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 .13 6 Test methods .13 6.1 Conditions13 6.2 Test methods for manifold pressure regulators 14 6.3 Test methods for line pressure regulators .20 6.4 Test

29、 method for determination of the auto-ignition temperature of sealing materials and lubricants .21 6.5 Test method for durability of markings and colour coding 22 7 Marking, colour coding, packaging.23 7.1 Marking.23 7.2 Colour coding 24 7.3 Packaging.25 8 Information to be supplied by the manufactu

30、rer .25 Annex A (informative) Examples of pressure regulators26 Annex B (informative) Rationale28 Annex C (informative) Reported regional and national deviations of colour coding and nomenclature for medical gases .30 Bibliography32 Annex ZA (informative) Relationship between this European Standard

31、and the Essential Requirements of EU Directive 93/42/EEC Medical Devices 33 EN ISO 10524-2:2006 (E) 4 Introduction Manifold pressure regulators are used to reduce cylinder pressure to a lower pressure within a source of supply of a medical gas pipeline system. Line pressure regulators are used to re

32、duce the pressure supplied by manifold pressure regulators or by cryogenic vessels to the lower pressure required at the terminal units of medical gas pipeline systems. These functions cover a wide range of inlet and outlet pressures and flows which require specific design characteristics. It is imp

33、ortant that the operating characteristics of manifold and line pressure regulators are specified and tested in a defined manner. It is essential that regular inspection and maintenance be undertaken to ensure that the pressure regulators continue to meet the requirements of this part of ISO 10524. T

34、his part of ISO 10524 pays particular attention to: use of suitable materials; safety (mechanical strength, leakage, safe relief of excess pressure and resistance to ignition); cleanliness; type testing; marking; information supplied by the manufacturer. Annex B contains rationale statements for som

35、e of the requirements of this part of ISO 10524. The clauses and subclauses marked with an asterisk (*) after their number have corresponding rationale included to provide additional insight into the reasoning that led to the requirements and recommendations that have been incorporated into this par

36、t of ISO 10524. 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. EN ISO 10524-2:2006 (E) 5 1 Scope 1.1* This part of ISO 10524 specifies requirements for manifold

37、 pressure regulators (as defined in 3.6) intended to be connected to cylinders with nominal filling pressures up to 25 000 kPa at 15 C and for line pressure regulators (as defined in 3.4) for inlet pressures up to 3 000 kPa and intended for use in pipeline systems for the following medical gases: ox

38、ygen; nitrous oxide; air for breathing; carbon dioxide; oxygen/nitrous oxide mixtures; air for driving surgical tools; nitrogen for driving surgical tools; oxygen produced by an oxygen concentrator. 1.2* This part of ISO 10524 applies to manifold pressure regulators and line pressure regulators supp

39、lied as individual units or to the relevant components incorporated within an assembly. 1.3 This part of ISO 10524 does not apply to pressure regulators for use with vacuum pipeline systems. NOTE Requirements for pressure regulators for use with vacuum pipeline systems are covered in ISO 10079-3. 2

40、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 referenced document (including any amendments) applies. ISO 32:1977, Gas cylinders f

41、or medical use Marking for identification of content ISO 7396-1:2002, Medical gas pipeline systems Part 1: Pipelines for compressed medical gases and vacuum ISO 14971:2000, Medical devices Application of risk management to medical devices ISO 15001:2003, Anaesthetic and respiratory equipment Compati

42、bility with oxygen EN 837-1:1996, Pressure gauges Part 1: Bourdon tube pressure gauges Dimensions, metrology, requirements and testing EN ISO 10524-2:2006 (E) 6 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 closure pressure P4stabilized out

43、let pressure, after cessation of the flow, from a pressure regulator when the flow has been set to standard discharge 3.2 double-stage pipeline distribution system pipeline distribution system in which gas is initially distributed from the supply system at a higher pressure than the nominal distribu

44、tion pressure NOTE This higher pressure (nominal supply system pressure) is then reduced to the nominal distribution pressure by additional line pressure regulators. 3.3 flow characteristic variation of outlet pressure in relation to flow with the inlet pressure remaining constant 3.4 line pressure

45、regulator pressure regulator intended to be installed within a medical gas pipeline system downstream of a manifold pressure regulator or cryogenic gas supply system 3.5 manifold device for connecting the outlet(s) of one or more cylinders or cylinder bundles of the same medical gas to a pipeline sy

46、stem 3.6 manifold pressure regulator pressure regulator intended to be installed within sources of supply containing cylinders or cylinder bundles 3.7 medical gas pipeline system complete system which comprises a supply system, a monitoring and alarm system, a pipeline distribution system with termi

47、nal units at the points where medical gases or vacuum may be required 3.8 nominal distribution pressure pressure of gas which the pipeline system is intended to deliver at the terminal units 3.9 nominal inlet pressure P1upstream pressure (specified as a single value by the manufacturer) for which th

48、e pressure regulator is intended to be used NOTE P1for manifold pressure regulators is the maximum cylinder filling pressure at 15 C. EN ISO 10524-2:2006 (E) 7 3.10 nominal outlet pressure P2downstream pressure for the standard discharge, Q1, specified by the manufacturer 3.11 pressure characteristi

49、c variation of the outlet pressure in relation to inlet pressure under constant flow conditions 3.12 pressure gauge device that measures and indicates pressure 3.13 pressure regulator device that reduces the inlet pressure and maintains the set outlet pressure within specified limits 3.14 pressure-relief valve device intended to relieve excess pressure at a pre-set value 3.15 single-fault condition condition in which a single means for protection against a safety hazard in equipment is defective or a single e