DIN EN ISO 15002-2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002 2008) English version of DIN EN ISO 15002 2008-11《与医疗气体管道系统的.pdf

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1、November 2008DEUTSCHE NORM English price group 14No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.10; 17.120.10!

2、$TJ“1493929www.din.deDDIN EN ISO 15002Flow-metering devices for connection to terminal units of medical gaspipeline systems (ISO 15002:2008)English version of DIN EN ISO 15002:2008-11Durchflussmesseinrichtungen zum Anschluss an Entnahmestellen vonRohrleitungssystemen fr medizinische Gase (ISO 15002:

3、2008)Englische Fassung DIN EN ISO 15002:2008-11SupersedesDIN EN 13220:1999-01www.beuth.deDocument comprises 31 pagesDIN EN ISO 15002:2008-11 2 National foreword This standard has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” (Secretariat: ANSI, USA) in colla

4、boration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” (Secretariat: BSI, United Kingdom). The responsible German body involved in its preparation was the Normenausschuss Rettungsdienst und Krankenhaus (Rescue Services and Hospital Standards Committee), Technical Commit

5、tee NA 053-03-06 AA 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: ISO 4135 DIN EN ISO 4135 ISO 5359 E DIN EN ISO 5359 ISO 7396-1 DIN EN ISO 7396-1 ISO 9170-1 DIN EN ISO 9170-1 I

6、SO 10524-1 DIN EN ISO 10524-1 ISO 10524-3 DIN EN ISO 10524-3 ISO 11114-3 DIN EN ISO 11114-3 ISO 14971 DIN EN ISO 14971 ISO 15001 DIN EN ISO 15001 ISO 19054 DIN EN ISO 19054 IEC 60601-1 DIN EN 60601-1 (VDE 0750-1) IEC 60601-1-6 DIN EN 60601-1-6 (VDE 0750-1-6) Amendments This standard differs from DIN

7、 EN 13220:1999-01 as follows: a) In the scope, a distinction has been drawn between gases and medical gases. b) Requirements for inlet and outlet connectors have been revised to take current standards into consideration. c) The duration for testing the mechanical strength is now specified as 5 min.

8、d) Requirements for flow-metering devices have been revised; a distinction is now made between flow-metering devices incorporating a flowmeter and a flow control valve, flow-metering devices incorporating a flowgauge and a fixed orifice with a flow control valve and flow-metering devices with one or

9、 more fixed orifices with means of selection. e) As regards cleanliness requirements, reference is made to ISO 15001. f) The test method for the determination of the autoignition temperature has been replaced by reference to ISO 11114-3. g) Table 1 with conversion coefficients for different test gas

10、es has been added. h) It is now required to indicate the direction of flow increase. i) The colour coding for xenon (Table 6) has been changed from light brown to bright green. j) Information to be supplied by the manufacturer has been revised with regard to safety-related items. DIN EN ISO 15002:20

11、08-11 3 k) Annex C (informative) relating to environmental aspects has been added. l) Annex D “Special national conditions” has been deleted. m) The standard has been editorially revised. Previous editions DIN EN 13220: 1999-01 National Annex NA (informative) Bibliography DIN EN 60601-1 (VDE 0750-1)

12、, Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN EN 60601-1-6, Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral Standard: Usability DIN EN ISO 4135, Anaesthesiology Vocabulary E

13、 DIN EN ISO 5359, Low-pressure hose assemblies for use with medical gases DIN EN ISO 7396-1, Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum DIN EN ISO 9170-1, Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed

14、 medical gases and vacuum DIN 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 10524-3, Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves D

15、IN EN ISO 11114-3, Compatibility of transportable gas cylinder and valve materials with gas content Part 3: Autogenous ignition test in oxygen atmosphere DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 15001, Anaesthetic and respiratory equipment Compat

16、ibility with oxygen DIN EN ISO 19054, Rail systems for supporting medical equipment DIN EN ISO 15002:2008-11 4 This page is intentionally blank EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 15002July 2008ICS 11.040.10 Supersedes EN 13220:1998 English VersionFlow-metering devices for connecti

17、on to terminal units ofmedical gas pipeline systems (ISO 15002:2008)Dispositifs de mesure de dbit pour raccordement auxprises murales des systmes de distribution de gazmdicaux (ISO 15002:2008)Durchflussmesseinrichtungen zum Anschluss anEntnahmestellen von Rohrleitungssystemen frmedizinische Gase (IS

18、O 15002:2008)This European Standard was approved by CEN on 21 June 2008.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliograph

19、ical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN

20、member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy,

21、 Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brus

22、sels 2008 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 15002:2008: E2 Contents Page Foreword 3 Introduction. 4 1 Scope 5 2 *Normative references. 6 3 Terms and definitions . 6 4 Arrangement of flow-metering systems and devices

23、 8 5 General requirements 8 5.1 Safety 8 5.2 Alternative construction . 8 5.3 Materials . 8 5.4 Design requirements . 9 5.5 Constructional requirements . 14 6 Test methods 14 6.1 General 14 6.2 Test method for mechanical strength . 15 6.3 Test method for leakage . 15 6.4 Test method for durability o

24、f markings and colour coding 16 7 Marking, colour coding and packaging. 16 7.1 Marking . 16 7.2 Colour coding. 17 7.3 Packaging. 17 8 Information to be supplied by the manufacturer 17 Annex A (informative) Rationale19 Annex B (informative) Arrangements of flow-metering systems and devices . 21 Annex

25、 C (informative) Environmental aspects. 24 Bibliography 25 Annex ZA (informative) Correspondence between this International Standard and Directive 93/42/EEC . 26 DIN EN ISO 15002:2008-11 EN ISO 15002:2008 (E) Foreword This document (EN ISO 15002:2008) has been prepared by Technical Committee ISO/TC

26、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 by publication of an identical text or by

27、endorsement, at the latest by January 2009, and conflicting national standards shall be withdrawn at the latest by July 2010. 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 ide

28、ntifying any or all such patent rights. This document supersedes EN 13220:1998. 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 EC Directive. For relationship with EC Directive, se

29、e informative Annex ZA, which is an integral part of this document. 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, Cyprus, Czech Republic, Denmark, Estonia,

30、Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 15002:2008 has been approved by CEN as a

31、 EN ISO 15002:2008 without any modification. 3 DIN EN ISO 15002:2008-11 EN ISO 15002:2008 (E) Introduction Flow-metering devices are widely used for delivery of medical gases supplied by a medical gas supply system directly to a patient. These devices need to deliver accurate flows under varying con

32、ditions of temperature and inlet pressure. Therefore it is important that the operating characteristics be specified and tested in a defined manner. This International Standard pays particular attention to: safety (mechanical strength, safe relief of excess pressure, resistance to ignition); gas spe

33、cificity; cleanliness; suitability of materials; accuracy; testing; identification; information supplied. Annex A contains rationale statements for some of the requirements of this International Standard. The clauses and subclauses marked with an asterix (*) after their number have corresponding rat

34、ionale contained in informative Annex A, included to provide additional insight into the reasoning that led to the requirements and recommendations that have been incorporated in this International Standard. It is considered that knowledge of the reasons for the requirements will not only facilitate

35、 the proper application of this International Standard, but will expedite any subsequent revisions. 4 DIN EN ISO 15002:2008-11 EN ISO 15002:2008 (E) 1 Scope 1.1 This International Standard is applicable to: flow-metering devices that are connected, either directly or by means of flexible connecting

36、assemblies, and disconnected by the operator at terminal units of a medical gas pipeline system for flow adjustment, measurement and delivery of medical gases; flow-metering devices that are connected and disconnected by the operator at gas-specific connection points of devices such as pressure regu

37、lators. 1.2 This International Standard applies to: a) flow-metering devices intended to be used with the following medical gases: oxygen; nitrous oxide; medical air; carbon dioxide; oxygen/nitrous oxide mixture 50 %/50 % (by volume); specified mixtures of the gases listed above; b) flow-metering de

38、vices intended to be used with the following gases: oxygen-enriched air; helium; xenon. NOTE Regional or national regulations might permit use of oxygen-specific connection points for oxygen-enriched air. 1.3 This International Standard does not apply to electrical or electronic flow-metering device

39、s. 1.4 This International Standard does not apply to gases used for driving surgical tools. 5 DIN EN ISO 15002:2008-11 EN ISO 15002:2008 (E) 2 *Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited

40、 applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 32, Gas cylinders for medical use Marking for identification of content ISO 5359:2008, Low-pressure hose assemblies for use with medical gases ISO 7396-1, Medical gas pipeline syst

41、ems Part 1: Pipeline systems for compressed medical gases and vacuum ISO 9170-1, Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed medical gases and vacuum ISO 11114-3:1997, Transportable gas cylinders Compatibility of cylinder and valve materials with ga

42、s contents Part 3: Autogenous ignition test in oxygen atmosphere ISO 14971:2007, Medical devices Application of risk management to medical devices ISO 15001:2003, Anaesthetic and respiratory equipment Compatibility with oxygen ISO 19054, Rail systems for supporting medical equipment EN 837-1:1996, P

43、ressure gauges Part 1: Bourdon tube pressure gauges Dimensions, metrology, requirements and testing EN 1089-3:2004, Transportable gas cylinders Gas cylinder identification (excluding LPG) Part 3: Colour coding EN 13544-2, Respiratory therapy equipment Part 2: Tubing and connectors 3 Terms and defini

44、tions For the purposes of this document, the following terms and definitions apply. 3.1 diameter index safety system connectors DISS connectors any of a range of male and female components intended to maintain gas-specificity by allocation of a set of different diameters to the mating connectors for

45、 each particular gas 3.2 flowgauge device that measures pressure and is calibrated in units of flow NOTE The flowgauge does not measure flow. It indicates flow by measuring the pressure upstream of a fixed orifice. 3.3 flowmeter device that measures and indicates the flow of a specific gas 3.4 flow-

46、metering device device fitted with an inlet connector and an outlet connector and which incorporates one of the following: a) a flowmeter with a flow control valve; b) a flowgauge and a fixed orifice with a flow control valve; 6 DIN EN ISO 15002:2008-11 EN ISO 15002:2008 (E) c) one or more fixed ori

47、fices with a means of flow selection. NOTE Typical examples of flow-metering systems and devices are given in Figures B.1 and B.2. 3.5 gas-specific having characteristics which prevent connections between different gas services 3.6 gas-specific connection point that part of the socket which is the r

48、eceptor for a gas-specific probe 3.7 hose insert that portion of a connector which is pushed into and secured within the bore (lumen) of the hose 3.8 manufacturer natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the m

49、arket under his or her own name, regardless of whether these operations are carried out by that person or on his or her behalf by a third party 3.9 medical gas pipeline system complete system which comprises a supply system, a monitoring and alarm system and a pipeline distribution system with terminal units at the points where medical gases or vacuum may be required 3.10 medical gas supply system either a) a medical gas pipeline system or b) an installation having no permanent pipel