BS EN ISO 5359-2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases《麻醉和呼吸器 医疗气体设备用低压软管组件》.pdf

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1、BSI Standards PublicationBS EN ISO 5359:2014Anaesthetic and respiratoryequipment Low-pressurehose assemblies for use withmedical gasesBS EN ISO 5359:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 5359:2014.It supersedes BS EN ISO 5359:2008+A1:2011 whic

2、h is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/121/1, Breathing attachments and anaestheticmachines.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the nec

3、essaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 77900 8ICS 11.040.10; 23.040.70; 83.140.40Compliance with a British Standard cannot confer immunity fromlegal obligations.Thi

4、s British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 October 2014.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 5359 October 2014 ICS 11.040.10; 83.140.40 Supersedes EN ISO 5359:2008En

5、glish Version Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases (ISO 5359:2014) Matriel danesthsie et de ranimation respiratoire - Flexibles de raccordement basse pression pour utilisation avec les gaz mdicaux (ISO 5359:2014) Ansthesie- und Beatmungsgert

6、e - Niederdruck-Schlauchleitungssysteme zur Verwendung mit medizinischen Gasen (ISO 5359:2014) This European Standard was approved by CEN on 24 August 2014. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the

7、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 CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French

8、, 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 CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, C

9、roatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey an

10、d United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. N

11、o. EN ISO 5359:2014 EBS EN ISO 5359:2014EN ISO 5359:2014 (E) 3 Foreword This document (EN ISO 5359:2014) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment“ in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secret

12、ariat 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 the latest by April 2015, and conflicting national standards shall be withdrawn at the latest by October 2017. Attention is drawn t

13、o 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 such patent rights. This document supersedes EN ISO 5359:2008. This document has been prepared under a mandate given to CEN by

14、 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 document. According to the CEN-CENELEC Internal Regulations, the national stand

15、ards 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Lu

16、xembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 5359:2014 has been approved by CEN as EN ISO 5359:2014 without any modification. BS EN ISO 5359:2014EN ISO 5359:2014 (E)

17、4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means to conforming to E

18、ssential Requirements of the New Approach Directive 93/42/EEC, Council Directive of 14 June 1993 on the approximation of the laws of the Member States concerning medical devices” (Medical Device Directive). Once this standard is cited in the Official Journal of the European Union under that Directiv

19、e and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and a

20、ssociated EFTA regulations. Table ZA.1 Correspondence between this International Standard and Directive 93/42/EEC Clause(s)/subclause(s) of this International Standard Corresponding essential requirements of Directive 93/42/EEC Qualifying remarks/notes 4.5.3, 4.7.1, 6.3.1 7.2 4.5.1, 4.7.2 7.3 4.5.2,

21、 6.1.6, 7.3, 2nd dash 7.5 partially covered for phthalates; provision of rationale for using phthalates with the information to be provided not required 6.3.1 7.6 4.6.2.1, 4.6.7, 4.6.8, 4.6.9, 4.6.10, 4.6.11 9.1 4.5.2, 4.5.4, 4.6.2, 4.6.3, 4.6.5 9.2, first and second indents only second indent cover

22、ed for temperature and pressure 4.5.1, 4.7.1, 4.7.2 9.3 and via normative reference to ISO 15001 4.6.2, 4.6.3, 4.6.4, 4.6.5 12.7.1 4.6.7, 4.6.8, 4.6.9 12.7.4 4.6.4 12.8.1 6.1, 6.2, 7 13.1 6.2 13.2 only gas-specific colour coding is addressed. 6.1.2, 6.1.3, 7.2, 2nd dash 13.3 a) only covered if the n

23、ame and address of the authorized representative is placed on the label, if applicable 6.3.2 13.3 b) 6.1.5 13.3 e) 7.3 first dash, 7.4 13.6 d) installation is not applicable BS EN ISO 5359:2014EN ISO 5359:2014 (E) 5 7.3 first dash 13.6 i) 7.3, last dash 13.6 q) NOTE Where a reference from a clause o

24、f this standard to the risk management process is made, the risk management process needs to be in compliance to the Medical Devices Directive 93/42/EEC. This means that risks have to be reduced as far as possible, to a minimum, to the lowest possible level, minimized or removed, according to the wo

25、rding of the corresponding essential requirement. WARNING: Other requirements and other EU Directives may be applicable to the products falling within the scope of this International Standard. BS EN ISO 5359:2014ISO 5359:2014(E)Contents PageForeword ivIntroduction v1 Scope . 12 Normative references

26、23 Terms and definitions . 24 General requirements . 64.1 Risk management . 64.2 Usability 64.3 Clinical investigation 64.4 Safety . 64.5 Materials . 74.6 Design requirements . 74.7 Constructional requirements 105 Test methods 115.1 General 115.2 Test method for pressure drop 115.3 Test method for l

27、eakage . 115.4 Test method for gas specificity . 115.5 Test method for mechanical strength . 115.6 Test method for deformation under pressure 125.7 Test method for resistance to occlusion . 125.8 Test method for durability of markings and colour coding .136 Marking, colour coding and packaging 136.1

28、 Marking 136.2 Colour coding 146.3 Packaging 157 Information to be supplied by the manufacturer 15Annex A (informative) Rationale .17Annex B (informative) Environmental aspects .18Annex C (informative) Reported regional and national deviations of colour coding and nomenclature for medical gases .19B

29、ibliography .21 ISO 2014 All rights reserved iiiBS EN ISO 5359:2014ISO 5359:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out throug

30、h 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 liaison with ISO, also take part in the work. ISO collaborat

31、es closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval cri

32、teria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directivesAttention is drawn to the possibility that some of the elements of this document may be the subject of pate

33、nt rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received. www.iso.org/patentsAny trade name used in thi

34、s document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to

35、 Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 1, Breathing attachments and anaesthetic machines.This fourth edition cancels and replaces the third edition (ISO

36、5359:2008) and the Amendment ISO 5359:2008/Amd 1:2011, which has been technically revised as follows: deletion of the requirements on the dimensions and allocation of connectors (see ISO 18082); addition of definitions of terms; addition of requirements on risk management, usability, clinical invest

37、igation and leaching of substances; amendment of the marking requirements and requirements for information to be provided by the manufacturer.iv ISO 2014 All rights reservedBS EN ISO 5359:2014ISO 5359:2014(E)IntroductionThis International Standard has been prepared in response to the need for a safe

38、 method of connecting medical equipment to a fixed medical gas pipeline system or other medical gas supply system such 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

39、are subjected to commissioning procedures to avoid the possibility of cross-connections or contamination of the medical gas conveyed. However, hose assemblies are subjected to wear and tear, misuse and abuse throughout their relatively short service life and are frequently connected to, and disconne

40、cted from, the medical equipment and the fixed pipeline.While recognizing that no system is absolutely safe, this International Standard includes those requirements considered necessary to prevent foreseeable hazards arising from the use of hose assemblies. Operators should be continually alert to t

41、he possibility of damage being caused by external factors. Therefore regular inspection and repair should be undertaken to ensure that hose assemblies continue to meet the requirements of this International Standard.This International Standard pays particular attention to suitability of materials, g

42、as specificity, prevention of cross-connections, cleanliness, testing, identification, and information supplied.Requirements on respiratory therapy tubing are covered by ISO 17256, which refers to ISO 80369-2 on small bore connectors for breathing systems and driving gases.While the desirability of

43、achieving agreement on a single International Standard for screw-threaded connectors has never been in doubt, the present pattern of usage has made such agreement impossible.Nevertheless, fears that proliferation of individual national standards or practices will eventually result in potentially dan

44、gerous cross-connection between components for different gases have led to the choice of three screw-threaded connector systems, and one gas-specific quick connector system for use on low pressure hose assemblies. The three systems of non-interchangeable screw-threaded connectors are the diameter in

45、dex safety system (DISS), the non-interchangeable screw-threaded (NIST) system and the sleeve indexed system (SIS). Dimensions and allocation of these connectors to medical gases are not specified in this International Standard.Rationales for some of the requirements of this International Standard a

46、re given in Annex A. Such requirements are indicated by the asterisk (*) after the clause number in the main text. ISO 2014 All rights reserved vBS EN ISO 5359:2014BS EN ISO 5359:2014Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases1 Scope1.1 This Internat

47、ional Standard specifies requirements for low-pressure hose assemblies intended for use with the following medical gases: oxygen, nitrous oxide, medical air, helium, carbon dioxide, xenon, specified mixtures of the gases listed above, oxygen-enriched air, air for driving surgical tools, nitrogen for

48、 driving surgical tools,and for use with vacuum.1.2 *It applies to hose assemblies operating at pressures up to 1 400 kPa and for vacuum systems at pressures not greater than 60 kPa absolute.1.3 This International Standard does not specify the dimensions and allocation of the gas-specific inlet and

49、outlet connectors for the hose assemblies.NOTE 1 Specifications for the dimensions and allocation of diameter index safety system (DISS) connectors are specified in CGA V-5 28.NOTE 2 Specifications for the dimensions and allocation of sleeve indexed system (SIS) connectors are specified in AS 2896 23.NOTE 3 Dimensions and allocation of non-interchangeable screw-threaded (NIST) connectors are specified in ISO 18082 11.NOTE 4 Terminal units designed for quick connectors are specified in ISO 9170-1.1.4 This International