EN ISO 10524-1-2006 en Pressure regulators for use with medical gases Part 1 Pressure regulators and pressure regulators with flow-metering devices《医用气体设备用的压力调节器 第1部分 压力调节器和带流量计设备的.pdf

1、BRITISH STANDARDBS EN ISO 10524-1:2006Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devicesThe European Standard EN ISO 10524-1:2006 has the status of a British StandardICS 11.040.10g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50

2、g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 10524-1:2006This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 September 2006

3、BSI 2006ISBN 0 580 49164 1National forewordThis British Standard was published by BSI. It is the UK implementation of EN ISO 10524-1:2006. It is identical with ISO 10524-1:2006. It supersedes BS EN 738-1:1997 which is withdrawn.The UK participation in its preparation was entrusted by Technical Commi

4、ttee CH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/6, Medical gas supply systems. A list of organizations represented on CH/121/6 can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are res

5、ponsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.Amendments issued since publicationAmd. No. Date CommentsEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10524-1 February 2006 ICS 11.040.10 Supersedes EN 738-1:1997English

6、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: Dtendeurs et dtendeurs dbitmtre intgr (ISO 10524-1:2006) Druckminderer zur Verwendun

7、g 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 CEN/CENELEC Internal Regulations which stipulate the conditions for giving this Euro

8、pean 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 to any CEN member. This European Standard exists in three official versions (English

9、, 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 versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech

10、 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 COMIT EUROP

11、EN DE NORMALISATION EUROPISCHES 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. Ref. No. EN ISO 10524-1:2006: EForeword This document (EN ISO 10524-1:2006) has been

12、 prepared by Technical Committee ISO/TC 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 b

13、y 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 supersedes EN 738-1:1997. This document has been prepared under a mandate given to CEN by the European Commission and

14、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 document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the fol

15、lowing 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, Sp

16、ain, 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 10524-1:2006Reference numberISO 10524-1:2006(E)INTERNATIONAL STANDARD ISO10524-1First edition2006-02-01Pressure regulators fo

17、r use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices Dtendeurs pour lutilisation avec les gaz mdicaux Partie 1: Dtendeurs et dtendeurs dbitmtre intgr EN ISO 10524-1:2006ii iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative reference

18、s . 2 3 Terms and definitions. 2 4 Nomenclature 4 5 General requirements. 4 5.1 Safety . 4 5.2 Alternative construction 4 5.3 Materials 4 5.4 Design requirements 5 5.5 Constructional requirements. 12 6 Test methods. 12 6.1 General. 12 6.2 Test methods for outlet pressure 13 6.3 Test method for press

19、ure-relief valve. 14 6.4 Test methods for leakage 14 6.5 Test method for mechanical strength. 15 6.6 Test method for resistance to ignition . 15 6.7 Test method for accuracy of flow of pressure regulators fitted with flowmeters or flowgauges 16 6.8 Test method for the stability of flow of pressure r

20、egulators fitted with flowmeters or flowgauges 16 6.9 Test method for stability and accuracy of flow of pressure regulators fitted with fixed orifices . 16 6.10 Test method for flow setting and loosening torques 16 6.11 Test method for durability of markings and colour coding 16 7 Marking, colour co

21、ding, packaging 16 7.1 Marking 16 7.2 Colour coding 18 7.3 Packaging 18 8 Information to be supplied by the manufacturer. 18 Annex A (informative) Typical examples of pressure regulators and pressure regulators with flow-metering devices. 22 Annex B (informative) Rationale . 26 Annex C (informative)

22、 Reported regional and national deviations of colour coding and nomenclature for medical gases. 28 Bibliography . 30 EN ISO 10524-1:2006Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing

23、International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaiso

24、n with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of tec

25、hnical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is dra

26、wn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 10524-1 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 6,

27、 Medical gas systems. This first edition cancels and replaces ISO 10524:1995 and ISO 10524:1995/Cor 1:1996, which has been technically revised. ISO 10524 consists of the following parts, under the general title Pressure regulators for use with medical gases: Part 1: Pressure regulators and pressure

28、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 For the purposes of this part of ISO 10524, the CEN annex regarding fulfilment of European Council Directives has been remov

29、ed. EN ISO 10524-1:2006vIntroduction 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 and flows which require specif

30、ic 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 orifice. The flow can be indic

31、ated 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 suitable materials; safety (mechan

32、ical 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 10524. The clauses and subclauses

33、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 considered that knowledge of the r

34、easons for the requirements will not only facilitate the proper application of this part of ISO 10524, but will expedite any subsequent revisions. EN ISO 10524-1:2006blank1Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices 1

35、Scope 1.1 This part of ISO 10524 is applicable to the types of pressure regulators listed in 1.3 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;

36、xenon; mixtures of the gases listed above; air for driving surgical tools; nitrogen for driving 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

37、 flow of the medical gas delivered. 1.3 The types of pressure regulators covered by this part 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

38、 the operator; c) pressure regulators that are an integral part of medical equipment (e.g. anaesthetic workstations, lung ventilators, resuscitators). EN ISO 10524-1:20062 2 Normative references The following referenced documents are indispensable for the application of this document. For dated refe

39、rences, only the edition cited applies. For undated references, the latest edition of the 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 conn

40、ections ISO 5145:2004, Cylinder valve outlets for gases and gas mixtures Selection and dimensioning 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

41、 vacuum ISO 14971:2000, Medical devices Application of risk management to medical devices 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 13544-2:200

42、2, Respiratory therapy equipment Part 2: Tubing and connectors SS 01 91 02, Colour Atlas 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 per

43、cent 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 NOTE The flowg

44、auge does not measure flow. It indicates flow by measuring the pressure upstream of a fixed 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 pro

45、be EN ISO 10524-1:200633.7 gas-specific having characteristics that prevent connection 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

46、for which the pressure regulator is intended to be used NOTE For compressed gases (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 restrict

47、ion 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. 3.12 preset pressure regulator pressure regulator that is not provided with a means of operator adjustment of the outlet pres

48、sure 3.13 pressure gauge device that measures and indicates pressure 3.14 pressure 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 de

49、vice intended to relieve excess pressure 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 IEC 60601-1 EN ISO 10524-1:20064 4 Nomenclature Examples of pressure regulators with terminology are given in Annex A. 5 General requirements 5.1 Safety Pressure regulators shall, when transported, stored, installed, operated in normal use and maintained accord