EN ISO 10524-3-2006 en Pressure regulators for use with medical gases - Part 3 Pressure regulators integrated with cylinder valves (Incorporates Amendment A1 2013)《医疗气体用压力调节器 第3部分 .pdf

1、BRITISH STANDARDBS EN ISO 10524-3:2007Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valvesThe European Standard EN ISO 10524-3:2007 has the status of a British StandardICS 11.040.10 BS EN ISO 10524-3:2006 +A1:2013BS EN ISO 10524-3:2006+A1:2013ISB

2、N 978 0 580 71251 7Amendments/corrigenda issued since publicationDate Comments31 May 2013 Implementation of ISO amendment 1:2013 with CEN endorsement A1:2013: Subclauses 5.4.9 and 8.1 modified and Annex ZA insertedThis British Standard was published under the authority of the Standards Policy and St

3、ategy Committee on 31 January 2008 The British Standards Institution 2013. Published by BSI Standards Limited 2013National forewordThis British Standard is the UK implementation of EN ISO 10524-3:2006+A1:2013. It is identical to ISO 10524-3:2005, incorporating amendment 1:2013. It supersedes BS EN I

4、SO 10524-3:2006, which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/6, Medical gas supply systems.A list of organizations represented on this subcommittee can be obtained on request to

5、its secretary.The publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 10524-3April

6、2006ICS 11.040.10 Supersedes EN 738-3:1998 English VersionPressure regulators for use with medical gases - Part 3:Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)Dtendeurs pour lutilisation avec les gaz mdicaux - Partie3: Dtendeurs intgrs dans les robinets des bouteilles degaz

7、(ISO 10524-3:2005)Druckminderer zur Verwendung mit medizinischen Gasen -Teil 3: Druckminderer in Flaschenventilen (ISO 10524-3:2005)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

8、 giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official ver

9、sions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cy

10、prus, 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, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMI

11、T EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 10524-3:2006: EEN ISO 10524-3:2006+A1March 2013Foreword The text

12、of ISO 10524-3:2005 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic andrespiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as EN ISO10524-3:2006 by Technical Committee CEN/TC 215 “Respiratoryand anaesthetic equipment“, thesecret

13、ariat of which is held by BSI. This European Standard shall be given the status ofa national standard, either by publication of an identical text or by endorsement, at the latest by October 2006, and conflicting national standards shall be withdrawn atthe latest by October 2006.This document superse

14、des EN 738-3:1998. 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 isan integral part of thi

15、s document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountriesare bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,

16、Latvia, Lithuania,Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden,Switzerland and United Kingdom. Endorsement noticeThe text of ISO 10524-3:2005 has been approved by CEN as EN ISO 10524-3:2006 without any modifications.EN ISO 10524-3:2007BS EN ISO

17、 10524-3:2006+A1:2013EN ISO 10524-3:2006+A1:2013BS EN ISO 10524-3:2006+A1:2013EN ISO 10524-3:2006+A1:2013EN ISO 10524-3:2006/A1:2013 (E) 3 Foreword This document (EN ISO 10524-3:2006/A1:2013) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment“ in collaboration

18、 with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat of which is held by BSI. This Amendment to the European Standard EN ISO 10524:2006 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the lates

19、t by September 2013, and conflicting national standards shall be withdrawn at the latest by March 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all su

20、ch patent rights. 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. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this docu

21、ment. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, Franc

22、e, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 10524-3: 2005/Amd 1:2013 has been approved by

23、CEN as EN ISO 10524-3:2006/A1:2013 without any modification. Foreword to amendment A1BS EN ISO 10524-3:2006+A1:2013EN ISO 10524-3:2006+A1:2013EN ISO 10524-3:2006/A1:2013 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC

24、This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide one means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC, Medical devices. Once this standard is cited in the Official

25、Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the normative clauses of this standard confers, within the limits of the scope of this standard, a presumption of conformity with the relevant Essential Re

26、quirements of that Directive and associated EFTA regulations. WARNING: Other requirements and other EU Directives may be applicable to the products falling within the scope of this standard. Reference numberISO 10524-3:2005(E)INTERNATIONAL STANDARDISO10524-3First edition2005-05-01Pressure regulators

27、 for use with medical gases Part 3: Pressure regulators integratedwith cylinder valvesDtendeurs pour lutilisation avec les gaz mdicaux Partie 3: Dtendeurs intgrs aux valves des bouteilles de gaz EN ISO 10524-3:2007ii ii iiiContents PageForewordivIntroduction v1Scope12Normative references .13Terms an

28、d definitions.24Symbols .45General requirements.45.1 Safety45.2 Alternative construction.45.3 Materials.45.4 Design requirements 55.5 Constructional requirements.126Test methods.136.1Conditions136.2 Test methods for outlet pressure146.3Test method for pressure-relief valve.156.4 Test methods for lea

29、kage.156.5Test method for mechanical strength.166.6 Test method for resistance to ignition176.7 Test method for accuracy of flow of pressure regulators integrated with cylinder valves fitted with flowmeters or flowgauges206.8 Test method for the stability of flow of pressure regulators integrated wi

30、th cylinder valves fitted with flowmeters or flowgauges206.9 Test method for stabilityand accuracy of flow of pressure regulators integrated with cylinder valves fitted with fixed orifices.206.10 Test method for flow setting and loosening torques206.11 Drop test.216.12 Impact test .216.13 Test metho

31、d for means of gas shut-off 226.14 Test method for non-return valve of filling port.226.15Test method for durability of markings and colour coding227Marking, colour coding, packaging.227.1 Marking.227.2 Colour coding237.3 Packaging 238* Information to be supplied by the manufacturer.24Annex A (infor

32、mative) Examples of pressure regulators integrated with cylinder valves .26Annex B (normative) Rationale.29Annex C (informative) Reported regional and national deviations of colour coding and nomenclature for medical gases.31Bibliography.33Annex ZA (informative) Relationship between this European St

33、andard and the EssentialEN ISO 10524-3:2007Requirements of EU Directive 93/42/EEC Medical Devices 34BS EN ISO 10524-3:2006+A1:2013ISO 10524-3:2005+A1:2013iii iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies

34、). The work of preparing International Standards is normally carried out through ISO technical committees. Each member bodyinterested in a subject for which a technical committee has beenestablished has the right to be represented on that committee. International organizations, governmental and non-

35、governmental, in liaison with ISO, also take part in the work. ISO collaborates closelywith 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

36、.The main task of technical committees is to prepare International Standards. Draft International Standardsadopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval byat least 75 % of the member bodies casting a vot

37、e. Attention is drawn 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. ISO10524-3 was prepared by Technical Committee ISO/TC121, Anaesthetic and respiratory equipment, S

38、ubcommittee SC 6, Medical gas systems. ISO10524 consists of the following parts, under the general title Pressure regulators for use with medicalgases: Part 1: Pressure regulatorsand pressure regulators with flow-metering devices Part 2:Manifold and line pressure regulators Part 3: Pressure regulato

39、rsintegrated with cylinder valves Part 4: Low-pressure regulatorsEN ISO 10524-3:2007BS EN ISO 10524-3:2006+A1:2013ISO 10524-3:2005+A1:2013iv vIntroduction Pressure regulators integrated with cylinder valves are used to reducehigh cylinder pressure to a lowerpressure suitable for use with medical equ

40、ipment or for deliveryof gas directly to a patient. These functions cover a wide range of inlet and outlet pressures and flowswhich require specific designcharacteristics. It is important that the operating characteristics of pressure regulators integrated with cylindervalves be specified and tested

41、 in a defined manner. A pressure regulator normallyhas coupled to it a device which controls the flow, such as a flow control valve or a fixed orifice. The flow can be indicated bya flowmeter or bya flowgauge. It is essential that regular inspection and maintenance be undertaken to ensure that the p

42、ressure regulatorscontinue to meet the requirements of this part of ISO 10524. This 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); gas specificity; cleanliness; type testing;

43、 marking; information supplied by the manufacturer.AnnexB contains rationale statements for some of the requirements of this part of ISO10524. The clausesand subclauses marked with an asterisk (*) after their number have corresponding rationale included toprovide additional insight into the reasonin

44、g that led to the requirements and recommendations that have beenincorporated into this partof ISO10524. It is considered that knowledge of the reasons for the requirementswill not only facilitate the proper application of this part of ISO10524, but will expedite any subsequentrevisions. EN ISO 1052

45、4-3:2007BS EN ISO 10524-3:2006+A1:2013ISO 10524-3:2005+A1:2013blank1Pressure regulators for use with medical gases Part 3: Pressure regulators integratedwith cylinder valves 1 Scope 1.1 This part of ISO 10524 applies to pressure regulators integrated with cylinder valves (as definedin 3.16) intended

46、 for the administration of medical gases in the treatment, management, diagnostic evaluation and care of patients for use with the following medical gases: oxygen; nitrous oxide; air for breathing; helium; carbon dioxide; xenon; specified mixtures of the gases listed above; air for driving surgical

47、tools; nitrogen for driving surgical tools.1.2 * These pressure regulators integrated with cylinder valves are intended to be fitted to cylinderswith nominal filling pressures up to 25000 kPa at 15 C and can be provided with devices that control andmeasure the flow of the medical gas delivered. 2 No

48、rmativereferencesThe following referenced documents are indispensable for the application of this document. For datedreferences, only the edition cited applies. For undated references, the latest edition of the referenceddocument (including anyamendments) applies.ISO 32:1977, Gas cylinders for medical use Marking for identification of contentISO 407:2004, Small medical gas cylinders Pin-index yoke-type valve connectionsISO 5145, Cylinder valve outlets