BS EN ISO 5367-2014 Anaesthetic and respiratory equipment Breathing sets and connectors《麻醉和呼吸器 呼吸组和连接器》.pdf

1、BSI Standards PublicationBS EN ISO 5367:2014Anaesthetic and respiratoryequipment Breathing setsand connectors BS EN ISO 5367:2014Incorporating corrigendum November 2014BS EN ISO 5367:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 5367:2014. It supersed

2、es BS EN 12342:1998+A1:2009 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/5, Airways and related equipment.A list of organizations represented on this subcommittee can be obtained

3、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 2014. Published by BSI Standards Limited 2014ISBN 978 0 580 88689 8ICS 11.040.10Compliance with a

4、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 2014.Amendments/corrigenda issued since publicationDate Text affected31 December 2014 Implementation of CEN Correction

5、Notice 12 November 2014: Annex ZA added, CEN Foreword updatedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 5367 October 2014 ICS 11.040.10 Supersedes EN 12342:1998+A1:2009English Version Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014) Matriel danesths

6、ie et de ranimation respiratoire - Systmes respiratoires et raccords (ISO 5367:2014) Ansthesie- und Beatmungsgerte - Atemsets und Verbindungsstcke (ISO 5367:2014) This European Standard was approved by CEN on 18 July 2014. CEN members are bound to comply with the CEN/CENELEC Internal Regulations whi

7、ch 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 CEN-CENELEC Management Centre or to any CEN member. This Eu

8、ropean 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 CEN-CENELEC Management Centre has the same status as the official versions. CEN members

9、are the national standards bodies 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, Poland, Portugal,

10、Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and 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 an

11、d by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 5367:2014 EEN ISO 5367:2014 (E) 3 Foreword This document (EN ISO 5367:2014) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” in collaboration with Technical Committee CEN/TC 215 “Re

12、spiratory 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 endorsement, at the latest by April 2015, and conflicting national standards shall be withdrawn at t

13、he latest by October 2017. 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 such patent rights. This document supersedes EN 12342:1998+A1:2009. This docume

14、nt 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 is an integral part of this document. According to the

15、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, France, Germany, Greece, Hun

16、gary, 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 5367:2014 has been approved by CEN as EN ISO 5367:2014 without any mo

17、dification. BS EN ISO 5367:2014EN ISO 5367:2014 (E)EN ISO 5367:2014 (E) 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 t

18、he European Free Trade Association to provide one means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Memb

19、er State, compliance with the normative 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 associated EFTA regulations. NOTE When an Essential Requireme

20、nt does not appear in Table ZA.1, it means that it is not addressed by this standard. Table ZA 1 Correspondence between this European Document and Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/notes 5.1 4.3 7.1 (2nd, and

21、 3rd indents) 5.1.1 7.1 7.2 7.2 5.1.1 mandates that these devices shall satisfy the biological safety testing indicated in ISO 10993-1 7.1 and 7.2 covers the integrity of the packaging only for devices supplied sterile 4.1.1 4.1.2 5.1 7.3 first part 4.1.1, 4.1.2, and 5.1 mandates a risk assessment b

22、e carried out which does not exclude risks associated with materials and the substances with which they may come into contact. 5.1.3, 8.3.m) 7.5 Partly addressed by 5.1.3 and 8.3.m) calls specifically for a warning if phthalates are incorporated 7.1, 7.2, 8.3.a) 8.1 Partly addressed. 7.1 and 8.3.a)

23、mandate that sterile devices are clearly marked according to EN 5561 mandates the requirements of ISO 11607-1 to ensure that the packaging is suitable to prevent contamination during transportation and use. 7.2 8.3 Partly addressed by 7.2 which mandates the requirements of ISO 11607-1 that the packa

24、ging is suitable to prevent contamination during transportation and use. 7.1 8.4 BS EN ISO 5367:2014EN ISO 5367:2014 (E)EN ISO 5367:2014 (E) 5 Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/notes 7.1 8.5 8.3.a) 8.7 Partly covered. Marked ste

25、rile if appropriate 5.3 5.4 5.5 5.6 6 9.1 Generally covered by mandating construction and testing of the interface connectors, leakage, resistance, compliance, resistance to tube collapse and kinking. 5.2 5.3 5.4 5.5 5.6 8.3 c) 8.3 d), e), f), g), m) 8.4.1 8.4.2 8.4.3 8.4.5 9.2 (first three indents)

26、 Partly covered to address only the risk of injury in connection with their physical features by specifying sizing and marking conventions for the ID/OD of the breathing tubes, and leakage, resistance, and compliance when performance tested in accordance with parameters associated with a declared pa

27、tient category. 5.3.1 5.3.2 5.3.3 5.3.5 5.3.6 12.7.4 Partly addressed for conical gas connectors only. 8 8.1 8.2 8.3 8.4 13.1 8.1 13.2 Generally covered. Symbols are mandated in 8.1 to conform to EN 1041, ISO 7000 or ISO 15223-1 8.2 a) 8.3 i) 13.3 a) BS EN ISO 5367:2014EN ISO 5367:2014 (E)EN ISO 536

28、7:2014 (E) 6 Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/notes 8.3 c) 8.3 d) 8.3 e) and f) 8.3 g) 8.3 h) 13.3 b) Covered for patient category, length, resistance, total compliance and internal diameter. 8.3 a) 13.3 c) 8.3 j) 13.3 d) 8.3.k

29、) 13.3 e) 8.3.b) 13.3 f) 8.4.2 8.4.3 8.4.4 8.4.5 13.3 j) Partly addressed with requirements for instructions for typical components or processes. 8.3 l) 8.3 m) 13.3 k) 8.3 a) 13.3 m) Partly addressed. Method of sterilization is addressed only as a recommendation. 8.4.5 13.5 Partly addressed. Limited

30、 to detachable connectors, which are sized in accordance with ISO 5356-1 instructs users on coaxial integrity testing 8, 8.1, 8.2, 8.3, 8.4 13.6 , a), b), c) 8.4.4 8.3 l) 13.6 h) Partly addressed. Risks associated with the reuse of devices marked for single use are covered partly by the risk managem

31、ent file and use of the informative Annex F Hazard identification for risk assessment 8.4.5 13.6 i) Partly addressed. Details for coaxial set user tests are mandated 8.4.6 13.6 q) NOTE Where a reference from a clause of this standard to the risk management process is made, the risk management proces

32、s 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 wording of the corresponding essential requirement WARNING Other requirements and ot

33、her EU Directives may be applicable to the product(s) falling within the scope of this standard BS EN ISO 5367:2014EN ISO 5367:2014 (E)BS EN ISO 5367:2014ISO 5367:2014(E)Contents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 24 General requirements . 44.1

34、Risk management . 44.2 Usability 44.3 Clinical evaluation 54.4 Biophysical or modelling research 54.5 Test methods . 54.6 Recommended service life 55 Specific requirements . 55.1 Materials . 55.2 Length . 55.3 Means of connection 65.4 Leakage 75.5 Resistance to flow . 75.6 Compliance . 86 Prevention

35、 of electrostatic charges 97 Requirements for breathing sets and breathing tubes supplied sterile 97.1 Sterility assurance 97.2 Packaging of breathing sets and breathing tubes supplied sterile. 98 Marking .108.1 General 108.2 Marking of breathing sets and breathing tubes .108.3 Marking of packages 1

36、08.4 Information to be supplied by the manufacturer .12Annex A (informative) Rationale .13Annex B (informative) Hazard identification for risk assessment .23Annex C (normative) Test for security of attachment of plain end to conical connector 24Annex D (normative) Test for security of attachment of

37、adaptor to breathing tube 25Annex E (normative) Test for leakage 26Annex F (normative) Measurement of resistance to flow 28Annex G (normative) Test for increase in flow resistance with bending .31Annex H (normative) Test for compliance .33Bibliography .35 ISO 2014 All rights reserved iiiBS EN ISO 53

38、67:2014ISO 5367:2014(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 through ISO technical committees. Each member body interested in a

39、 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 collaborates closely with the International Electrotechnical Commissio

40、n (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 criteria needed for the different types of ISO documents should

41、 be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).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 ident

42、ifying 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 (see www.iso.org/patents).Any trade name used in this document is information given for the convenie

43、nce 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 Trade (TBT) see the following URL: Foreword - S

44、upplementary informationThe committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 2, Airways and related equipment.This fifth edition cancels and replaces the fourth edition (ISO 5367:2000), which has been technically revised.The following majo

45、r changes were made: title and scope; additional normative references; additional terms and definitions; additional general requirements, including risk management, usability, clinical and biophysical research; requirements for coaxial tubing, revised leakage limits, and testing for flow resistance

46、and compliance; revised limits for prevention of electrostatic charges; revised requirements for marking of packaging, including the use of symbols, disclosure of intended patient category, flow resistance and compliance; added an annex for rationale; added an annex for hazard identification for ris

47、k assessment; revised test method annexes for resistance to flow, security of attachments, leakage and compliance; added an annex for compliance with the EU Directives.iv ISO 2014 All rights reservedBS EN ISO 5367:2014ISO 5367:2014(E)IntroductionThis International Standard contains requirements for

48、breathing sets, breathing tubes, and connectors that are intended to function as accessories to anaesthetic and respiratory equipment. Breathing sets and breathing tubes are characterized by certain design requirements such as a means of connection and leakage limits. Disclosure requirements for com

49、pliance and flow resistance values allow the user to make an informed choice when connecting these accessories to a breathing system. These design requirements are intended to allow operation within the limits of performance of the anaesthetic breathing systems and ventilator breathing systems with which the accessories are intended to operate.This International Standard includes requirements for both single-use and reusable breathing sets and breathing tubes. Re-usable breathing sets and breathing tubes are intended to comply with the