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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 738-2:1999 Incorpor
2、ating Corrigendum No. 1 The European Standard EN 738:1998 has the status of a British Standard ICS 11.040.10; 23.060.40 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Pressure regulators for use with medical gases Part 2: Manifold and line pressure regulators BS EN 738-2:1999
3、 This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 March 1999 BSI 03-2000 ISBN 0 580 30687 9 Amendments issued since publication Amd. No.DateText aff
4、ected 10802 Corr. No. 1 March 2000Changes 100 mm to 100 mm in 5.4.3. National foreword This British Standard is the English language version of EN 738-2:1998. The UK participation in its preparation was entrusted to Technical Committee CH/44, Anaesthetic machines, breathing attachments, medical gas
5、pipeline systems and hose assemblies, to Subcommittee CH/44/2, which has the responsibility to: aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related intern
6、ational and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found
7、in the BSI Standards Catalogue under the section entitled International Standards Correspondence Index, or by using the Find facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are r
8、esponsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 23 and a back cover. The BSI copyright notice displayed
9、 in this document indicates when the document was last issued. CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1998 CEN All rights of exploitation in any form and by any means res
10、erved worldwide for CEN national Members. Ref. No. EN 738-2:1998 E EUROPEAN STANDARDEN 738-2 NORME EUROPE ENNE EUROPA ISCHE NORM October 1998 ICS 11.040.10; 23.060.40 Descriptors: gas distribution, gas cylinders, medical gases, pressure regulators, specifications, safety requirements, design, perfor
11、mance evaluation, tests, marking, packing English version Pressure regulators for use with medical gases Part 2: Manifold and line pressure regulators De tendeurs pour lutilisation avec les gaz me dicaux Partie 2: De tendeurs de rampes et de canalisations Druckminderer zur Verwendung mit medizinisch
12、en Gasen Teil 2: Hauptstellendruckregler und Leitungsdruckminderer This European Standard was approved by CEN on 2nd October 1998. 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 stand
13、ard without any alteration. Up-to-date lists and bibliographical references 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 la
14、nguage 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 versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece
15、, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Page 2 EN 738-2:1998 BSI 03-2000 Foreword This European Standard has been prepared by Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, the secretariat of which i
16、s 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 April 1999, and conflicting national standards shall be withdrawn at the latest by April 1999. This European Standard has been prepar
17、ed 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 standard. EN 738 consists of the following pa
18、rts under the general title Pressure regulators for use with 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 inten
19、ded for incorporation into medical equipment. For special national conditions see annex A. Annex A forms a normative part of this European Standard. Annexes B, C, D and ZA are given for information only. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the f
20、ollowing countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword2 Introduction3 1Scope3
21、2Normative references3 3Definitions3 4Symbols and terminology4 5General requirements5 6Test methods7 7Marking, colour coding, packaging10 8Information to be supplied by the manufacturer10 Annex A (normative) Special national conditions18 Annex B (informative) Examples of pressure regulators19 Annex
22、C (informative) Bibliography21 Annex D (informative) Rationale21 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives22 ? Page 3 EN 738-2:1998 BSI 03-2000 Introduction Manifold pressure regulators are used to reduce the high
23、cylinder pressure to a lower pressure suitable for the supply of medical gas pipeline systems. Line pressure regulators are used to reduce the pressure supplied by manifold pressure regulators or by cryogenic vessels (complete with control and monitoring equipment) to the lower pressure available at
24、 the terminal units of medical gas pipeline systems which is 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 and flows which require specific design characteristics. It is important that the operat
25、ing characteristics of manifold and line pressure regulators are specified and tested in a defined manner. This European Standard specifies the provision of information for: installation and testing; inspection, maintenance and the frequency of such activities. Testing after installation is critical
26、 to patient safety and it is essential that manifold and line pressure regulators are not used until full testing in accordance with EN 737-3 has been completed. This European Standard pays particular attention to: suitability of materials; safety (mechanical strength, safe relief of excess pressure
27、 and resistance to ignition); cleanliness; testing; identification; information supplied. Clauses and sub-clauses marked with R after their numbers have corresponding rationales contained in annex D. 1 Scope 1.1 This European Standard applies to manifold pressure regulators and line pressure regulat
28、ors intended for the supply of pipeline systems for the following medical gases: oxygen; nitrous oxide; air for breathing; carbon dioxide; oxygen/nitrous oxide mixture (50/50 % (v/v); air for driving surgical tools; nitrogen for driving surgical tools. 1.2 This European Standard does not apply to pr
29、essure regulators for use with suction services (see ISO 10079-3). 2 Normative references This European Standard incorporates, by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publication are listed
30、hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN 737-3, Medical gas pipeline
31、systems Part 3: Pipelines for compressed medical gases and vacuum. EN 837-1, Pressure gauges Part 1: Bourdon tube pressure gauges Dimensions, metrology, requirements and testing. EN 1441, Medical devices Risk analysis. ISO 32, Gas cylinders for medical use Marking for identification of content. 3 De
32、finitions For the purposes of this European Standard, the following definitions apply. 3.1 adjustable pressure regulator regulator which has been provided with a means of operator adjustment of the delivery pressure under normal use 3.2 closure pressure, P4 stabilized outlet pressure, one minute aft
33、er cessation of the flow, from a regulator where the flow has been set to standard discharge 3.3 flow characteristic variation of the outlet pressure in relation to the rate of flow from zero to maximum capacity flow of the regulator with the inlet pressure remaining constant 3.4 hysteresis lagging
34、of the outlet pressure (effect) when the flow (cause) is varied so that at a constant inlet pressure the values of outlet pressure measured with increasing flow do not coincide with the values of outlet pressure measured with decreasing flow 3.5 line pressure regulator pressure regulator with a maxi
35、mum inlet pressure of 3 000 kPa intended to be fitted within a medical gas pipeline system ? Page 4 EN 738-2:1998 BSI 03-2000 3.6 manifold pressure regulator pressure regulator with a maximum inlet pressure of 20 000 kPa intended to be installed within sources of supply containing cylinders 3.7 maxi
36、mum closure pressure, P4max stabilized outlet pressure, one minute after cessation of the flow, from a regulator where the flow has been set to maximum discharge 3.8 maximum discharge, Qmax maximum flow which is delivered by the regulator at the rated outlet pressure P2at test inlet pressure P3 3.9
37、medical gas pipeline system central supply system with control equipment, a pipeline distribution system and terminal units at the points where medical gases or vacuum are required 3.10 preset pressure regulator regulator which has not been provided with a means of operator adjustment of the deliver
38、y pressure under normal use 3.11 pressure characteristic variation of the outlet pressure with inlet pressure under constant flow conditions 3.12 pressure gauge gauge which measure and indicates a pressure 3.13 pressure regulator device for regulation of a generally variable inlet pressure to as con
39、stant as possible an outlet pressure 3.14 rated inlet pressure, P1 rated maximum upstream pressure for which the pressure regulator is designed 3.15 rated outlet pressure, P2 rated downstream pressure for the standard discharge Q1specified in the instructions for use 3.16 relief valve device designe
40、d to relieve excess pressure from the low pressure side at a preset value 3.17 single fault condition condition in which a single means for protection against a safety hazard in equipment is defective or a single external abnormal condition is present 3.18 source of supply supply system with associa
41、ted control equipment which supplies the pipeline 3.19 standard discharge, Q1 flow, specified in the instructions for use for which the regulator is designed to maintain a rated outlet pressure P2at test inlet pressure P3 3.20 test inlet pressure, P3 minimum inlet pressure at which the standard disc
42、harge of the regulator Q1is measured and which is equivalent to twice the rated outlet pressure P2 plus 100 kPa, (i.e. P3= (2P2+ 100) kPa) 3.21 test outlet pressure, P5 highest or lowest value of the outlet pressure resulting from a variation in the inlet pressure between P1 and P3at previously adju
43、sted conditions P1, P2, Q1. 4 Symbols and terminology The symbols used for the physical characteristics are given in Table 1. A diagram of a typical manifold pressure regulator with examples of terminology is given in Figure B.1. A diagram of a typical line pressure regulator with examples of termin
44、ology is given in Figure B.2. Table 1 Notations, symbols and designations P1rated inlet pressure P2rated outlet pressure P3test inlet pressure (2P2+ 100) kPa P4closure pressure P4 maxmaximum closure pressure P5test outlet pressure Q1standard discharge Qmaxmaximum discharge QRVdischarge of the relief
45、 valve Rcoefficient of pressure increase upon closure P42 P2 P2 i irregularity coefficient P52 P2 P2 ? Page 5 EN 738-2:1998 BSI 03-2000 5 General requirements 5.1 Safety Manifold and line pressure regulators shall, when stored, installed, operated in normal use and maintained according to the instru
46、ctions of the manufacturer, cause no safety hazard which could be foreseen using risk analysis procedures in accordance with EN 1441 and which is connected with their intended application, in normal condition and in single fault condition. 5.2 R Alternative construction Manifold and line pressure re
47、gulators and components or parts thereof, using materials or having forms of construction different from those detailed in clause 5 of this European Standard shall be accepted if it can be demonstrated that an equivalent degree of safety is obtained. Such evidence shall be provided by the manufactur
48、er. See annex A for special national conditions. 5.3 Materials 5.3.1 The materials in contact with the gas shall be compatible with oxygen, the other medical gases and their mixtures in the temperature range specified in 5.3.2. NOTE 1 Corrosion resistance includes resistance against moisture and sur
49、rounding materials. NOTE 2 Compatibility with oxygen involves both combustibility and ease of ignition. Materials which burn in air will burn violently in pure oxygen. Many materials which do not burn in air will do so in pure oxygen, particularly under pressure. Similarly, materials which can be ignited in air require lower ignition energies for ignition in oxygen. Many such materials can be ignited by friction at a valve seat or by adiabatic compression produced when oxygen a