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1、BRITISH STANDARDS BS EN 738-4:1999 Incorporating Amendment No. 1 Pressure regulators for use with medical gases Part 4: Low-pressure regulators intended for incorporation into medical equipment The European Standard EN 738-4:1998, with the incorporation of amendment A1:2002, has the status of a Brit
2、ish Standard ICS 11.040.10; 23.060.40 ? Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 03:15:28 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 738-4:1999 This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the
3、authority of the Standards Committee and comes into effect on 15 March 1999 BSI 16 October 2002 ISBN 0 580 30689 5 National foreword This British Standard is the English language version of EN 738-4:1998, including amendment A1:2002. The start and finish of text introduced or altered by amendment is
4、 indicated in the text by tags ?. Tags indicating changes to CEN text carry the number of the CEN amendment. For example, text altered by CEN amendment A1 is indicated by ?. The UK participation in its preparation was entrusted to Technical Committee CH/44, Anaesthetic machines, breathing attachment
5、s, medical gas pipeline systems and hose assemblies, to Subcommittee CH/44/2, Medical gas supply systems, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement inte
6、rnational or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not pur
7、port to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible European committee any enquiri
8、es on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 20, an inside bac
9、k cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No.DateComments 1371916 October 2002See national foreword Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 03:15:28 GMT+00:00 2006
10、, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 738-4 October 1998 + A1 April 2002 ICS 11.040.10; 23.060.40 Descriptors: medical equipment, utilization, medical gases, pressure regulators, safety, materials, design, performance evaluation, flow rate, mechanical stre
11、ngth, tests, marking, packing English version Pressure regulators for use with medical gases Part 4: Low-pressure regulators intended for incorporation into medical equipment (includes amendment A1:2002) Dtendeurs pour lutilisation avec les gaz mdicaux Partie 4: Dtendeurs basse pression conus pour l
12、e matriel mdical (inclut lamendement A1:2002) Druckminderer zur Verwendung mit medizinischen Gasen Teil 4: Niederdruckminderer zum Einsetzen in medizinische Gerte (enthlt nderung A1:2002) This European Standard was approved by CEN on 2 October 1998, and CEN amendment A1 was approved on 4 March 2002.
13、 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 references concerning such national standards may be obtained on
14、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 into its own language and notified to the Central Secretariat
15、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, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European
16、Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1998 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 738-4:1998 + A1:2002 E Licens
17、ed Copy: sheffieldun sheffieldun, na, Tue Nov 07 03:15:28 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 738-4:1998 BSI 16 October 2002 2 Foreword This European Standard has been prepared by Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, the Secretariat of which is held by BSI
18、. 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 prepared under a ma
19、ndate 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 parts under the
20、 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 intended for inc
21、orporation into medical equipment. For special national conditions see Annex A. Annex A forms a normative part of this European Standard. Annex B, Annex C, Annex D and Annex ZA are given for information only. According to the CEN/CENELEC Internal Regulations, the national standards organizations of
22、the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Foreword to amendment A1 This doc
23、ument EN 738-4:1998/A1:2002 has been prepared 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 publication of an identical text or by endorsement, at t
24、he latest by October 2002, and conflicting national standards shall be withdrawn at the latest by October 2002. 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). Acc
25、ording to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway,
26、 Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword 2 Introduction 3 1 Scope 3 2 Normative references 3 3 Definitions 4 4 Symbols and terminology 5 5 General requirements 5 6 Test methods 8 7 Marking and packaging 16 8 Information to be supplied by the manufacturer 1
27、6 Annex A (normative) Special national conditions 17 Annex B (informative) Example of pressure regulators 18 Annex C (informative) Bibliography 18 Annex D (informative) Rationale 19 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU D
28、irectives 20 Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 03:15:28 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 738-4:1998 BSI 16 October 2002 3 Introduction Pressure regulators are fitted within medical equipment to maintain a constant outlet pressure irrespective of variation of inlet p
29、ressure or flow. To enable correct application of these devices it is important that the operating characteristics are specified and tested in a defined manner. As pressure regulators of this type are often derived from products designed for industrial applications, this European Standard pays parti
30、cular attention to: suitability of materials; safety (mechanical strength and resistance to ignition); cleanliness; testing; identification; information supplied. It is also essential that regular inspection and maintenance procedures are recommended. Clauses and subclauses marked with R after their
31、 numbers have corresponding rationales contained in Annex D. 1 Scope 1.1 This European Standard applies to low-pressure regulators suitable for inlet pressures between 280 kPa and 600 kPa, supplied and packaged as for use in medical equipment intended for the administration of medical gases in the t
32、reatment, management, diagnostic evaluation and care of patients for use with the following medical gases: oxygen; nitrous oxide; air for breathing; helium; carbon dioxide; xenon; ? NO/N2 mixtures (NO?1 000 ?l/l);? specified mixtures of the gases listed above. 1.2 This European Standard does not app
33、ly to pressure regulators supplied as spare parts for a specific application. 1.3 This European Standard does not apply to pressure regulators for use with suction services (see EN ISO 10079-3). 2 Normative references This European Standard incorporates, by dated or undated reference, provisions fro
34、m other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revision of any of these publications apply to this European Standard only when incorporated in it by amendmen
35、t or revision. For undated references the latest edition of the publication referred to applies. EN 737-1, Medical gas pipeline systems Part 1: Terminal units for compressed medical gases and vacuum. prEN 737-6, Medical gas pipeline systems Part 6: Dimensions of probes for terminal units for compres
36、sed medical gases and vacuum. EN 739, Low-pressure hose assemblies for use with medical gases. EN 1441, Medical devices Risk analysis. Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 03:15:28 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 738-4:1998 4 BSI 16 October 2002 3 Definitions For the
37、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 bleed flow intended small flow of gas to the atmosphere for the purpose of the co
38、rrect operation of the regulator 3.3 closure pressure, P4 stabilized outlet pressure, one minute after cessation of the flow, from a regulator where the flow has been set to standard discharge 3.4 flow characteristic variation of the outlet pressure in relation to the rate of flow from zero to maxim
39、um capacity flow of the regulator with the inlet pressure remaining constant 3.5 hysteresis lagging 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 outl
40、et pressure measured with decreasing flow 3.6 low pressure pressure of 1 400 kPa or less 3.7 maximum closure pressure, P4 max stabilized outlet pressure, one minute after cessation of the flow, from a regulator where the flow as been set to maximum discharge 3.8 maximum discharge, Qmax maximum flow
41、which is delivered by the regulator at the rated outlet pressure, P2 at test inlet pressure, P3 3.9 preset pressure regulator regulator which has not been provided with a means of operator adjustment of the delivery pressure under normal use 3.10 pressure characteristic variation of the outlet press
42、ure with inlet pressure under constant flow conditions 3.11 pressure regulator device for regulation of a generally variable inlet pressure to as constant as possible an outlet pressure 3.12 rated inlet pressure, P1 rated maximum upstream pressure for which the pressure regulator is designed 3.13 ra
43、ted outlet pressure, P2 rated downstream pressure for the standard discharge Q1 specified in the instructions for use Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 03:15:28 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 738-4:1998 BSI 16 October 2002 5 3.14 single fault condition condition i
44、n which a single means for protection against a safety hazard in equipment is defective or a single external abnormal condition is present 3.15 single stage pressure regulator regulator that reduces the inlet pressure in a single stage to the required pressure 3.16 standard discharge, Q1 flow, speci
45、fied in the instructions for use for which the regulator is designed to maintain a rated outlet pressure, P2 at test inlet pressure P3 3.17 test inlet pressure, P3 minimum inlet pressure at which the standard discharge of the regulator Q1 is measured and which is equivalent to twice the rated outlet
46、 pressure P2 plus 100 kPa, i.e. P3 = (2 P2 + 100) kPa 3.18 two stage pressure regulator regulator that reduces the inlet pressure in two stages to the required pressure 4 Symbols and terminology The symbols used for the physical characteristics are given in Table 1. A diagram of typical pressure reg
47、ulators with examples of terminology is given in Figure B.1. Table 1 Notations, symbols and designations 5 General requirements 5.1 Safety Pressure regulators shall, when stored, installed, operated in normal use and maintained according to the recommendations of the manufacturer, cause no safety ha
48、zard which could be foreseen using risk analysis procedures in accordance with EN 1441 and which is connected with their intended applications, in normal condition and in single fault condition. 5.2 R Alternative construction Pressure regulators and components or parts thereof, using materials or ha
49、ving 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 manufacturer. See Annex A for special national conditions. P1 rated inlet pressure P2 rated outlet pressure P3 test inlet pressure (2 P2 + 100) kPa P4 closure pressure P4 m