BS EN 80369-5-2016 Small-bore connectors for liquids and gases in healthcare applications Connectors for limb cuff inflation applications《卫生保健设施中液体和气体用小口径连接器 上肢袖口充气应用连接》.pdf

1、Small-bore connectors for liquids and gases in healthcareapplicationsPart 5: Connectors for limb cuff inflation applicationsBS EN 80369-5:2016BS EN 80369-5:2016Incorporating corrigendum February 2017(IEC 80369-5:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06EU

2、ROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 80369-5November 2016ICS 11.040.20English VersionSmall-bore connectors for liquids and gases in healthcareapplications - Part 5: Connectors for limb cuff inflation applications(IEC 80369-5:2016)Raccords de petite taille pour liquides et gaz utiliss dans

3、 le domaine de la sant - Partie 5: Raccords destins desapplications au gonflage de brassard(IEC 80369-5:2016)Verbindungsstcke mit kleinem Durchmesser frFlssigkeiten und Gase in medizinischen Anwendungen -Teil 5: Verbindungsstcke fr Anwendungen mitaufblasbaren Manschettensystemen fr Gliedmaen(IEC 803

4、69-5:2016)This European Standard was approved by CENELEC on 8 April 2016. CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.Up-to-date lists a

5、nd bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN and CENELEC member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translatio

6、n under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria

7、,Croatia, 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

8、d United KingdomEuropean Committee for Electrotechnical StandardizationComit Europen de Normalisation ElectrotechniqueEuropisches Komitee fr Elektrotechnische NormungCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN/CENELECAll rights of exploitation in any form and by any mea

9、ns reserved worldwide for CEN national Members and forCENELEC Members.Ref. No. EN 80369-5:2016 EBS EN 80369-5:2016BS EN 80369-5:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 80369-5:2016. It is identical to IEC 80369-5:2016, incorporating corrigendum Febr

10、uary 2017.The UK participation in its preparation was entrusted by Technical Committee CH/210, Quality management and corresponding general aspects for medical devices, to Subcommittee CH/210/5, Small Bore Connectors for Medical Devices.A list of organizations represented on this committee can be ob

11、tained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017. Published by BSI Standards Limited 2017ISBN 978 0 580 97918 7ICS 11.040.20Compliance

12、with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2016.Amendments/corrigenda issued since publicationDate Text affected30 April 2017 Implementation of IEC corrige

13、ndum February 2017: Table H.2, row for reference K correctedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 80369-5 November 2016 ICS 11.040.20 English Version Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications (IEC 8

14、0369-5:2016) Raccords de petite taille pour liquides et gaz utiliss dans le domaine de la sant - Partie 5: Raccords destins des applications au gonflage de brassard (IEC 80369-5:2016) Verbindungsstcke mit kleinem Durchmesser fr Flssigkeiten und Gase in medizinischen Anwendungen - Teil 5: Verbindungs

15、stcke fr Anwendungen mit aufblasbaren Manschettensystemen fr Gliedmaen (IEC 80369-5:2016) This European Standard was approved by CENELEC on 8 April 2016. CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Stan

16、dard 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 CEN-CENELEC Management Centre or to any CEN and CENELEC member. This European Standard exists in three official vers

17、ions (English, French, German). A version in any other language made by translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN and CENELEC members are the national stan

18、dards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway

19、, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Avenue Marnix

20、 17, B-1000 Brussels 2016 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN 80369-5:2016 E BS EN 80369-5:2016EN 80369-5:2016 2 European foreword The text of document 62D/1306/FDIS, future edition 1 of

21、IEC 80369-5, prepared by SC 62D “Electromedical equipment” of IEC/TC 62 “Electrical equipment in medical practice”, ISO/TC 210 “Quality management and corresponding general aspects for medical devices” and CEN/CENELEC TC 3/WG 2 “Smallbore connectors”, was submitted to the IEC-CENELEC parallel vote a

22、nd approved by CENELEC as EN 80369-5:2016. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2017-05-04 latest date by which the national standards conflicting with the doc

23、ument have to be withdrawn (dow) 2019-11-04 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a ma

24、ndate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For the relationship with EU Directive see informative Annex ZZ, which is an integral part of this document. Endorsement notice The text of the Internati

25、onal Standard IEC 80369-5:2016 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: ISO 3040:2009 NOTE Harmonized as EN ISO 3040:2012 1)(not modified). ISO 81060-1:2007 NO

26、TE Harmonized as EN ISO 81060-1:2012 (not modified). IEC 60601-1-11:2015 NOTE Harmonized as EN 60601-1-11:2015 (not modified). IEC 60601-1-12:2014 NOTE Harmonized as EN 60601-1-12:2015 (not modified). IEC 62366-1:2015 NOTE Harmonized as EN 62366-1:2015 (not modified). IEC 80601-2-30:2009 NOTE Harmon

27、ized as EN 80601-2-30:2010 (not modified). IEC 80601-2-30:2009/A1:2013 NOTE Harmonized as EN 80601-2-30:2010/A1:2015 (not modified). ISO 80369-20:2015 NOTE Harmonized as EN ISO 80369-20:2015 (not modified). ISO 80369-6:2016 NOTE Harmonized as EN ISO 80369-6:2016 (not modified). ISO 80369-2 2)NOTE Ha

28、rmonized as EN ISO 80369-2 2)(not modified). ISO 80369-3:2016 NOTE Harmonized as EN ISO 80369-3:2016 (not modified). 1)Superseded by EN ISO 3040:2016 (ISO 3040:2016). 2)At draft stage. BS EN 80369-5:2016EN 80369-5:2016 3 Annex ZA (normative) Normative references to international publications with th

29、eir corresponding European publications The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (in

30、cluding any amendments) applies. NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here: www.cenelec.eu P

31、ublication Year Title EN/HD Year - - Respiratory therapy equipment - Part 2: Tubing and connectors EN 13544-2 +A1 2002 2009 ISO 5356-1 2004 Anaesthetic and respiratory equipment - Conical connectors - Part-1: Cones and sockets EN ISO 5356-1 2004 3)ISO 5356-1 2015 Anaesthetic and respiratory equipmen

32、t - Conical connectors - Part 1: Cones and sockets EN ISO 5356-1 2015 ISO 5356-2 2006 Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors EN ISO 5356-2 2007 4)ISO 5356-2 2012 Anaesthetic and respiratory equipment - Conical connectors - Part 2

33、: Screw-threaded weight-bearing connectors EN ISO 5356-2 2012 ISO 8185 2007 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems EN ISO 8185 2009 ISO 14971 2007 Medical devices - Application of risk management to medical devices EN ISO 14971

34、2012 ISO 80369-1 2010 Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements EN ISO 80369-1 2010 ASTM D638-14 - Standard test method for tensile properties of plastics - - ASTM D790-10 - Standard test methods for flexural properties of unreinforced and

35、reinforced plastics and electrical insulating materials - - 3)Superseded by EN ISO 5356-1:2015 (ISO 5356-1:2015). 4)Superseded by EN ISO 5356-2:2012 (ISO 5356-2:2012). BS EN 80369-5:2016EN 80369-5:2016 2 European foreword The text of document 62D/1306/FDIS, future edition 1 of IEC 80369-5, prepared

36、by SC 62D “Electromedical equipment” of IEC/TC 62 “Electrical equipment in medical practice”, ISO/TC 210 “Quality management and corresponding general aspects for medical devices” and CEN/CENELEC TC 3/WG 2 “Smallbore connectors”, was submitted to the IEC-CENELEC parallel vote and approved by CENELEC

37、 as EN 80369-5:2016. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2017-05-04 latest date by which the national standards conflicting with the document have to be withd

38、rawn (dow) 2019-11-04 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CENELEC

39、 by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For the relationship with EU Directive see informative Annex ZZ, which is an integral part of this document. Endorsement notice The text of the International Standard IEC 8036

40、9-5:2016 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: ISO 3040:2009 NOTE Harmonized as EN ISO 3040:2012 1)(not modified). ISO 81060-1:2007 NOTE Harmonized as EN IS

41、O 81060-1:2012 (not modified). IEC 60601-1-11:2015 NOTE Harmonized as EN 60601-1-11:2015 (not modified). IEC 60601-1-12:2014 NOTE Harmonized as EN 60601-1-12:2015 (not modified). IEC 62366-1:2015 NOTE Harmonized as EN 62366-1:2015 (not modified). IEC 80601-2-30:2009 NOTE Harmonized as EN 80601-2-30:

42、2010 (not modified). IEC 80601-2-30:2009/A1:2013 NOTE Harmonized as EN 80601-2-30:2010/A1:2015 (not modified). ISO 80369-20:2015 NOTE Harmonized as EN ISO 80369-20:2015 (not modified). ISO 80369-6:2016 NOTE Harmonized as EN ISO 80369-6:2016 (not modified). ISO 80369-2 2)NOTE Harmonized as EN ISO 803

43、69-2 2)(not modified). ISO 80369-3:2016 NOTE Harmonized as EN ISO 80369-3:2016 (not modified). 1)Superseded by EN ISO 3040:2016 (ISO 3040:2016). 2)At draft stage. BS EN 80369-5:2016EN 80369-5:2016 3 Annex ZA (normative) Normative references to international publications with their corresponding Euro

44、pean publications The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments

45、) applies. NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here: www.cenelec.eu Publication Year Title

46、EN/HD Year - - Respiratory therapy equipment - Part 2: Tubing and connectors EN 13544-2 +A1 2002 2009 ISO 5356-1 2004 Anaesthetic and respiratory equipment - Conical connectors - Part-1: Cones and sockets EN ISO 5356-1 2004 3)ISO 5356-1 2015 Anaesthetic and respiratory equipment - Conical connectors

47、 - Part 1: Cones and sockets EN ISO 5356-1 2015 ISO 5356-2 2006 Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors EN ISO 5356-2 2007 4)ISO 5356-2 2012 Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weigh

48、t-bearing connectors EN ISO 5356-2 2012 ISO 8185 2007 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems EN ISO 8185 2009 ISO 14971 2007 Medical devices - Application of risk management to medical devices EN ISO 14971 2012 ISO 80369-1 2010

49、Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements EN ISO 80369-1 2010 ASTM D638-14 - Standard test method for tensile properties of plastics - - ASTM D790-10 - Standard test methods for flexural properties of unreinforced and reinforced plastics and electrical insulating materials - - 3)Superseded by EN ISO 5356-1:2015 (ISO 5356-1:2015). 4)Superseded by EN ISO 5356-2:2012 (ISO 5356-2:2012). BS EN 80369-5:2016EN 80369-5:2016 4 Annex ZZ (informative) Relationship between this Europ