BS EN 739-1998 Low-pressure hose assemblies for use with medical gases.pdf

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1、BRITISH STANDARD BS EN 739:1998 Incorporating Amendment No. 1 Low-pressure hose assemblies for use with medical gases The European Standard EN 739:1998, with the incorporation of amendment A1:2002, has the status of a British Standard ICS 11.040.10; 23.040.70 ? Copyright British Standards Institutio

2、n Reproduced by IHS under license with BSI - Uncontrolled Copy Document provided by IHS Licensee=Bureau Veritas/5959906001, 11/08/2004 05:38:29 MST Questions or comments about this message: please call the Document Policy Group at 303-397-2295. -,-,- BS EN 739:1998 This British Standard, having been

3、 prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 May 1998 BSI 16 October 2002 ISBN 0 580 29705 5 National foreword This British Standard is the English language version of EN 739:1998, inclu

4、ding amendment A1:2002, and covers hose assemblies and non-interchangeable screw-threaded (NIST) connectors. Together with BS EN 737-1:1998, which covers terminal units for compressed medical gases and vacuum, it partially supersedes BS 5682:1984 (as amended by AMD 5419:1987) which covered hose asse

5、mblies, terminal units and their connectors. The remainder of the content of BS 5682:1984, i.e. quick connect probes, is the subject of EN 737-6, currently in preparation. When published, EN 737-6 is expected to have a lengthy transitional period, the date of withdrawal of conflicting national stand

6、ards (DOW) being set several years in the future. BS 5682:1984 will be withdrawn on 13 June 1998 and replaced by a new edition (BS 5682:1998) which will retain only the requirements for quick connect probes given in the amended 1984 edition. This new edition is expected to co-exist with the forthcom

7、ing BS EN 737-6 until the expiry of the DOW of EN 737-6, at which time BS 5682:1998 will be withdrawn. The start and finish of text introduced or altered by amendment is indicated in the text by tags ?. Tags indicating changes to CEN text carry the number of the CEN amendment. For example, text alte

8、red by CEN amendment A1 is indicated by ?. Attention is drawn to the Special National Conditions in Annex A. The UK participation in its preparation was entrusted by Technical Committee CH/44, Anaesthetic machines, breathing attachments, medical gas pipeline systems and hose assemblies, to Subcommit

9、tee 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 international or European publications referred to in this document m

10、ay 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 purport to include all the necessary provisions of a contract. Us

11、ers 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 enquiries on the interpretation, or proposals for change, and keep th

12、e 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 25 and a back cover. The BSI copyright notice displayed in this document indica

13、tes when the document was last issued. Amendment issued since publication Amd. No.DateComments 1372216 October 2002See national foreword Copyright British Standards Institution Reproduced by IHS under license with BSI - Uncontrolled Copy Document provided by IHS Licensee=Bureau Veritas/5959906001, 1

14、1/08/2004 05:38:29 MST Questions or comments about this message: please call the Document Policy Group at 303-397-2295. -,-,- EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 739 January 1998 + A1 April 2002 ICS 11.040.10; 23.040.70 Descriptors: Gas distribution, medical gases, junctions, hoses,

15、 definitions, design, equipment specifications, mechanical properties, tests, marking, colour codes, packing English version Low-pressure hose assemblies for use with medical gases (includes amendment A1:2002) Flexibly de raccordement basse pression pour utilisation avec les gaz mdicaux (inclut l am

16、endement A1:2002) Niederdruck-Schlauchleitungssysteme zur Verwendung mit medizinischen Gasen (enthlt nderung A1:2002) This European Standard was approved by CEN on 5 July 1997 and amendment A1 was approved by CEN on 4 March 2002. CEN members are bound to comply with the CEN/CENELEC Internal Regulati

17、ons 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 application to the Central Secretariat or to any CEN member. This Europ

18、ean 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 has the same status as the official versions. CEN members are the natio

19、nal 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 Committee for Standardization Comit Europen de Normalisation Europische

20、s 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 739:1998 + A1:2002 E Copyright British Standards Institution Reproduced by IHS under license with BS

21、I - Uncontrolled Copy Document provided by IHS Licensee=Bureau Veritas/5959906001, 11/08/2004 05:38:29 MST Questions or comments about this message: please call the Document Policy Group at 303-397-2295. -,-,- EN 739:1998 BSI 16 October 2002 2 Foreword This European Standard has been prepared by CEN

22、/TC Technical Committee 215, Respiratory and anaesthetic equipment, of which the secretariat 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 the latest by July 1998, and conflicting national sta

23、ndards shall be withdrawn at the latest by July 1998. For special national conditions and transition periods for clauses 5.4.8 and 7.2.1 see Annex A. This European standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association and supports

24、essential requirements of EU Directive(s). For relationship with EU Directives, see informative Annex ZA, which is an integral part of this standard. Annex A forms a normative part of this European standard. Annex B and Annex C are informative. Dimensions of probes are specified in EN 737-6 (in cour

25、se of preparation), which has a date of withdrawal (DoW) of (DoP + 15 years). Until this time, national standards specifying dimensional requirements for the gas-specific connection point of the terminal unit may continue to be used for the maintenance and repair of systems. In accordance with the c

26、ommon CEN/CENELEC Internal Regulations, 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, United Kingdom.

27、Foreword to amendment A1 This document EN 739:1998/A1:2002 has been prepared by Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, the Secretariat of which is held by BSI. It has been prepared so as to accommodate the use of nitric oxide admixed with nitrogen as a medical gas. Th

28、is 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 October 2002, and conflicting national standards shall be withdrawn at the latest by October 2002. This document has been prepared under a mandate giv

29、en to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Aust

30、ria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Foreword2 Introduction3 1Scope3 2Normative references4 3Definitions4 4Terminology5 5General

31、requirements6 6Test methods9 7Marking, colour coding and packaging10 8Information to be supplied by the manufacturer11 Annex A (normative) Special national conditions23 Annex B (informative) Rationale23 Annex C (informative) Bibliography24 Annex ZA (informative) Clauses of this European Standard add

32、ressing essential requirements or other provisions of EU Directives24 Copyright British Standards Institution Reproduced by IHS under license with BSI - Uncontrolled Copy Document provided by IHS Licensee=Bureau Veritas/5959906001, 11/08/2004 05:38:29 MST Questions or comments about this message: pl

33、ease call the Document Policy Group at 303-397-2295. -,-,- ? EN 739:1998 BSI 16 October 2002 3 Introduction This European Standard has been prepared in response to the need for a safe method of connecting medical equipment to a fixed medical gas pipeline system or other medical gas supply system suc

34、h that hose assemblies carrying different gases, or the same gas at different pressures, cannot be interchanged. Fixed medical gas pipelines once installed are rarely disturbed and are subjected to commissioning procedures to avoid the possibility of cross-connections or contamination of the medical

35、 gas conveyed. However, hose assemblies are subjected to physical wear and tear, misuse and abuse throughout their relatively short service life and are frequently connected to, and disconnected from, the medical equipment and the fixed pipeline. While recognizing that no system is absolutely safe,

36、this standard includes those requirements considered necessary to prevent foreseeable hazards arising from the use of hose assemblies. Operators should be continually alert to the possibility of damage being caused by external factors and it is therefore essential that regular inspection and repair

37、is undertaken to ensure that hose assemblies continue to meet the requirements of this European Standard. This European standard pays particular attention to: suitability of materials; gas-specificity; cleanliness; testing; identification; information supplied. Rationales for some of the requirement

38、s of this European Standard are given in Annex B. Such requirements are indicated by the letter R after the clause number. 1 Scope 1.1 This European Standard specifies requirements for low-pressure hose assemblies intended for use with the following medical gases: oxygen; nitrous oxide; air for brea

39、thing; helium; carbon dioxide; xenon; ? NO/N2 mixtures (NO ? 1 000 ?l/l);? specified mixtures of the gases listed above; air for driving surgical tools; nitrogen for driving surgical tools; vacuum. It is intended especially to ensure gas-specificity and to prevent cross-connection between different

40、gases. These hose assemblies are intended to be used in the pressure range between 300 kPa and 1 400 kPa for compressed medical gases and between 10 kPa and 100 kPa absolute pressure for vacuum. 1.2 This European Standard does not specify the intended uses of hose assemblies. Some examples of the in

41、tended uses specified in other standards are as follows: a) between a terminal unit and medical equipment (see EN 737-1, prEN 740, EN 794-1); b) between the fixed pipeline system and a terminal unit of that system (prEN 737-3, EN 793); c) between a terminal unit and a second terminal unit (see prEN

42、737-3); d) between an emergency supply and an emergency and maintenance inlet point of a pipeline system (see EN 738-1, prEN 737-3); e) between an emergency supply and medical equipment (see EN 738-1, prEN 740, EN 794-1). Copyright British Standards Institution Reproduced by IHS under license with B

43、SI - Uncontrolled Copy Document provided by IHS Licensee=Bureau Veritas/5959906001, 11/08/2004 05:38:29 MST Questions or comments about this message: please call the Document Policy Group at 303-397-2295. -,-,- ? EN 739:1998 4 BSI 16 October 2002 1.3 This European Standard specifies the dimensions o

44、f non-interchangeable screw-threaded (NIST) connectors. 1.4 This European Standard does not specify: dimensions of probes and of the mating parts of the socket (see prEN 737-6); requirements for hose assemblies for anaesthetic gas scavenging systems; requirements for coaxial hoses used for the suppl

45、y and disposal of air for driving surgical tools; requirements for electrical conductivity. 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

46、 publications are listed 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

47、-1:1998, 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 compressed medical gases and vacuum. ?EN 1089-3, Transportable gas cylinders Cylinder identification Part

48、 3: Colour coding.? EN 1441, Medical devices Risk analysis. ISO 1402, Rubber and plastic hoses and hose assemblies Hydrostatic testing. ISO 32, Gas cylinders for medical use Marking for identification of content. ISO 554, Standard atmospheres for conditioning and/or testing Specifications. ISO 1307, Rubber and plastic hoses for general-purpose industrial applications Bore diameters and tolerances on length. ISO 8033 Rubber and plastic hose Determination of adhesion between component

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