BS EN ISO 7376-2009-08 Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation《麻醉和呼吸设备 气管插管术用喉镜》.pdf

1、BS EN ISO 7376:August 2009ICS 11.040.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDAnaesthetic and respiratory equipment Laryngoscopes for tracheal intubation (ISO 7376:2009)Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 08/11/2010 07:03, Uncontrolle

2、d Copy, (c) BSIThis British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August2010 BSI 2010ISBN 978 0 580 56612 7Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 7376:August 2009National forewordThis British Standard is the UK i

3、mplementation of EN ISO 7376:2009. It is identical to ISO 7376:2009. It supersedes BS EN ISO 7376:2009 (Identical to ISO 7376:2003) which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/121/5, Lung ventilators, tracheal tubes and related equipment.A list

4、of organizations represented on this committee can be obtained 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.Compliance with a British Standard cannot confer immunity from legal o

5、bligations.Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 08/11/2010 07:03, Uncontrolled Copy, (c) BSIEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7376 August 2009 ICS 11.040.10 Supersedes EN ISO 7376:2009, AprilEnglish Version Anaesthetic and respiratory equipment - Laryngoscope

6、s for tracheal intubation (ISO 7376:2009) Matriel danesthsie et de ranimation respiratoire - Laryngoscopes pour intubation trachale (ISO 7376:2009)Ansthesie- und Beatmungsgerte - Laryngoskope fr Trachealintubation (ISO 7376:2009) This European Standard was approved by CEN on 8 August 2009. CEN membe

7、rs 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 and bibliographical references concerning such national standards may be obtained on applicatio

8、n 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 translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has th

9、e same status as the official 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, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portug

10、al, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means r

11、eserved worldwide for CEN national Members. Ref. No. EN ISO 7376:2009: ELicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 08/11/2010 07:03, Uncontrolled Copy, (c) BSIEN ISO 7376:2009 (E) 3 Foreword This document (EN ISO 7376:2009) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic

12、 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 endorsement, at

13、the latest by February 2010, and conflicting national standards shall be withdrawn at the latest by March 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 identifying any o

14、r all such patent rights. This document supersedes EN ISO 7376:2009, April. 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 EU Directive. For relationship with EU Directive, see in

15、formative 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, Finl

16、and, 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 7376:2009 has been approved by CEN as a EN I

17、SO 7376:2009 without any modification. BS EN ISO 7376:August 2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 08/11/2010 07:03, Uncontrolled Copy, (c) BSIEN ISO 7376:2009 (E) 4 Annex ZA (informative) Relationship between this International Standard and the Essential Requirements of EU Dire

18、ctive 93/42/EEC This International Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC. Once this standard is cited in the Officia

19、l Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member 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

20、 corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this International Standard and Directive 93/42/EEC Clause(s)/subclause(s) of this International Standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remar

21、ks/Notes 4.1.1 1,2, 12.2, 12.9 4.1.2 1, 2, 12.9 4.2 7.1, 7.3 4.3.1 3, 4, 5 4.3.2 3, 4, 5 4.4 2, 9.3, 12.7.5, 12.8.2 5.1.1 3, 9.1 5.1.2 3 5.1.3 3, 7.1 5.1.4 7.1 5.2.1 3, 7.1 5.2.2 3, 7.1 5.3 5 5.4.1.1 3 5.4.1.2 3 5.4.2.1 3, 4, 12.2 5.4.2.2 12.7.4 5.4.2.3 12.7.4 5.4.2.4 12.7.4 5.4.3 3, 4, 12.2 5.5.1 2

22、, 3 5.5.2 2, 3 5.5.3 2, 3 5.5.4 3 5.6 12.7.1 BS EN ISO 7376:August 2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 08/11/2010 07:03, Uncontrolled Copy, (c) BSIEN ISO 7376:2009 (E) 5 Clause(s)/subclause(s) of this International Standard Essential requirements (ERs) of EU Directive 93/42/EE

23、C Qualifying remarks/Notes 5.7.1 12.7.1 5.7.2 12.7.1 5.8 12.7.1 6.1.1 12.7.4 6.1.2 2, 9.2 6.1.3 12.7.4 6.1.4 7.5, 7.6, 9.2, 12.7.1 6.1.5 12.7.4 6.2.1 2, 12.7.1 6.2.2 2, 12.7.1 7.1 2 7.2 12.7.4 8.1.1 2 8.1.2 12.7.1 8.1.3 12.7.1, 12.7.4 8.1.4 12.7.4 8.2.1 12.7.1 8.2.2 12.7.1 9.1 4, 8.1, 8.5 9.2 8.1, 1

24、3.6 (h) 10.1 13.1, 13.2 10.2 13.3 (a) The ER is not fully addressed. 10.3 13.1, 13.3 (b ,c, f) 10.4 13.6 (c) 10.5 13.6 (b) 10.6 13.3 (c, d, f), 13.5 ER 13.3 (f) is only partly addressed. 11 a) 13.6 (q) 11 b) 13.6 (c) 11 c) 13.3 (m), 13.6 (h) 11 d) 13.6 (g) 11 e) 13.6 (d) 11 f) 13.6 (d, k) 11 g) 13.1

25、, 13.4, 13.6 (n) 11 h) 13.3 (k), 13.4 11 i) 6, 13.6 (h) ER 6 (a) is not addressed. 11 j) 13.1, 13.3 (k), 13.6 (I) 11 k) 13.3 (e) 11 l) 12.2, 13.6 (d, h) 11 m) 13.3 (j) 11 n) 9.3, 13.6 (c) WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the scope

26、 of this International standard. BS EN ISO 7376:August 2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 08/11/2010 07:03, Uncontrolled Copy, (c) BSIISO 7376:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and d

27、efinitions. 2 4 General requirements. 3 4.1 Design 3 4.2 Materials for laryngoscope blades and single-piece laryngoscopes 3 4.3 Environmental requirements . 3 4.4 Internal electrical power source 3 5 Performance requirements 4 5.1 Illumination 4 5.2 Blade strength and rigidity 4 5.3 Blade and handle

28、 hook-on fittings 4 5.4 Handle fittings . 4 5.5 Blade fittings . 7 5.6 Engagement 7 5.7 Operating position 7 5.8 Disengagement . 7 6 Lamp for conventional blade. 9 6.1 Lamp and lamp base contact 9 6.2 Screw thread for lamps 10 7 Lamps for fibre-illuminated laryngoscopes. 11 8 Sockets for conventiona

29、l blades. 11 8.1 Dimensions and centre contact 11 8.2 Internal screw threads 11 9 Cleaning, disinfection and sterilization 11 10 Marking and labelling . 12 11 Accompanying documents 12 Annex A (normative) Test method for lamp contact security 14 Annex B (normative) Test methods for strength, rigidit

30、y and illumination . 15 Annex C (informative) Blade size markings. 17 Annex D (informative) Laryngoscope blade designs . 18 Annex E (informative) Rationale for inclusion of certain requirements . 25 Bibliography . 27 BS EN ISO 7376:August 2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 08

31、/11/2010 07:03, Uncontrolled Copy, (c) BSIISO 7376:2009(E) iv ISO 2009 All rights reservedForeword ISO (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 ou

32、t through 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 co

33、llaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International

34、Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the element

35、s of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 7376 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 2, Tracheal tubes and other equipment. This second

36、edition cancels and replaces the first edition (ISO 7376:2003), which has been technically revised. BS EN ISO 7376:August 2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 08/11/2010 07:03, Uncontrolled Copy, (c) BSIISO 7376:2009(E) ISO 2009 All rights reserved vIntroduction This Internatio

37、nal Standard gives requirements for laryngoscopes in tracheal intubation, hereinafter referred to as laryngoscopes, during anaesthesia, intensive care, emergency care and similar procedures, including requirements for reusable and single-use laryngoscope blades and handles. Laryngoscopes are manufac

38、tured in several forms and can, for example, be of single-piece handle and blade construction or have a detachable blade and handle. In the latter case, the light source for illuminating the larynx during use is either a lamp attached to a blade or a lamp in the handle with a light guide in the blad

39、e. The minimum illumination from the laryngoscope is defined/disclosed. The dimensions of laryngoscope blades are defined and disclosed to allow an informed decision by the operator to select the most appropriate instrument for intubation. Annexes A and B describe test methods. While Annexes C and D

40、 give blade markings and designs respectively, Annex E presents a rationale for certain subclauses in the main body of the document. BS EN ISO 7376:August 2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 08/11/2010 07:03, Uncontrolled Copy, (c) BSIBS EN ISO 7376:August 2009Licensed Copy: W

41、ang Bin, ISO/EXCHANGE CHINA STANDARDS, 08/11/2010 07:03, Uncontrolled Copy, (c) BSIINTERNATIONAL STANDARD ISO 7376:2009(E) ISO 2009 All rights reserved 1Anaesthetic and respiratory equipment Laryngoscopes for tracheal intubation 1 Scope This International Standard gives general requirements for lary

42、ngoscopes used for intubation, and specifies critical dimensions for the handle and lamp of hook-on type laryngoscopes. It also addresses the interchangeability of blades and handles. It is applicable only to instruments with an internal battery-operated power source for illuminating the larynx, sin

43、ce electrical safety requirements can be more stringent for instruments connected to mains or external power packs. It is not applicable to surgical instruments known by the same generic name, nor is it applicable to flexible laryngoscopes or laryngoscopes designed for surgery, laryngoscopes powered

44、 from mains electricity supply, laryngoscopes connected by light-transmitting cables to external light sources, or video laryngoscopes designed to work with an external video system. NOTE Instruments connected by light guides to an external light source could be subject to other International Standa

45、rds. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 5864, ISO inch sc

46、rew threads Allowances and tolerances ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing IEC 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance EN 1041, Information supplied by the manufacturer with medical

47、devices BS EN ISO 7376:August 2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 08/11/2010 07:03, Uncontrolled Copy, (c) BSIISO 7376:2009(E) 2 ISO 2009 All rights reserved3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 blade rigid la

48、ryngoscope component shaped to provide a direct view of the larynx 3.2 contact metallic part of a hook-on fitting that completes an electrical circuit between the handle and lamp when a detachable blade and handle are placed in the operating position 3.3 conventional blade detachable blade incorpora

49、ting a lamp, positioned to provide direct illumination of the larynx during use, and having an electrical connection to the handle in the hook-on fitting NOTE See Figure 1. 3.4 detachable blade blade that can be separated from a handle by the operator 3.5 engagement mechanical attachment of the blade and handle such that the blade remains coupled to the handle in all positions 3.6 fibre-illuminated blade blade incorporating optical fibres to transmit light from a source to illuminate the larynx NOTE See Figure 2. 3.7 handle component he