EN ISO 7376-2009 en Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation《麻醉和呼吸设备 气管插管用喉镜》.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)This British Standard was published under the authority of the Standards Policy and

2、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 implementation of EN ISO 7376:2009. It is identical to ISO 7376:2009. It supersedes BS EN ISO 7376:2

3、009 (Identical to ISO 7376:2003) which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/121/5, Lung ventilators, tracheal tubes and related equipment.A list of organizations represented on this committee can be obtained on request to its secretary.This pub

4、lication 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 obligations.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7376 August 2009 ICS 11.040.10

5、Supersedes EN ISO 7376:2009, AprilEnglish Version Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009) Matriel danesthsie et de ranimation respiratoire - Laryngoscopes pour intubation trachale (ISO 7376:2009)Ansthesie- und Beatmungsgerte - Laryngoskope fr Tra

6、chealintubation (ISO 7376:2009) This European Standard was approved by CEN on 8 August 2009. CEN 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

7、 lists and bibliographical references concerning such national standards may be obtained on application 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

8、 responsibility of a CEN member into its own language and notified to the CEN Management Centre has the 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, Hunga

9、ry, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre

10、: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 7376:2009: EEN ISO 7376:2009 (E) 3 Foreword This document (EN ISO 7376:2009) has been prepared by Technical Committee ISO/TC 121 “Anaesthe

11、tic 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,

12、at 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 an

13、y or 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

14、 informative 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, F

15、inland, 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 E

16、N ISO 7376:2009 without any modification. BS EN ISO 7376:August 2009EN ISO 7376:2009 (E) 4 Annex ZA (informative) Relationship between this International Standard and the Essential Requirements of EU Directive 93/42/EEC This International Standard has been prepared under a mandate given to CEN by th

17、e 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 Official Journal of the European Union under that Directive and has been implemented as a national stan

18、dard 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 corresponding Essential Requirements of that Directive and associated EFTA regulations. Table Z

19、A.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 remarks/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,

20、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, 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 2009EN ISO 7376:2009 (E) 5 Cl

21、ause(s)/subclause(s) of this International Standard Essential requirements (ERs) of EU Directive 93/42/EEC 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.

22、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, 13.6 (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

23、.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, 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

24、: Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this International standard. BS EN ISO 7376:August 2009ISO 7376:2009(E) ISO 2009 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms

25、 and definitions. 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

26、handle 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 conve

27、ntional 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, r

28、igidity 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 2009ISO 7376:2009(E) iv ISO 2009 All rights reservedFor

29、eword 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 out through ISO technical committees. Each member body interested in a subject for which a tech

30、nical 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 Commission (IEC) on all matters of

31、 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 Standards. Draft International Standards adopted by the technical committees are circulated t

32、o 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 elements of this document may be the subject of patent rights. ISO shall not be held responsible for

33、 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 edition cancels and replaces the first edition (ISO 7376:2003), which has been technically re

34、vised. BS EN ISO 7376:August 2009ISO 7376:2009(E) ISO 2009 All rights reserved vIntroduction This International Standard gives requirements for laryngoscopes in tracheal intubation, hereinafter referred to as laryngoscopes, during anaesthesia, intensive care, emergency care and similar procedures, i

35、ncluding requirements for reusable and single-use laryngoscope blades and handles. Laryngoscopes are manufactured 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 l

36、arynx during use is either a lamp attached to a blade or a lamp in the handle with a light guide in the blade. 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

37、the most appropriate instrument for intubation. Annexes A and B describe test methods. While Annexes C and D 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 2009BS EN ISO 7376:August 2009INTERNA

38、TIONAL 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 laryngoscopes used for intubation, and specifies critical dimensions for the handle and lamp o

39、f 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, since electrical safety requirements can be more stringent for instruments connected to mains

40、 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 from mains electricity supply, laryngoscopes connected by light-transmitting cables to ex

41、ternal 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 Standards. 2 Normative references The following referenced documents are indispensable for the a

42、pplication 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 screw threads Allowances and tolerances ISO 10993-1, Biological evaluation of medical device

43、s 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 devices BS EN ISO 7376:August 2009ISO 7376:2009(E) 2 ISO 2009 All rights reserved3 Terms a

44、nd definitions For the purposes of this document, the following terms and definitions apply. 3.1 blade rigid laryngoscope 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 det

45、achable blade and handle are placed in the operating position 3.3 conventional blade detachable blade incorporating 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 b

46、lade 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

47、the larynx NOTE See Figure 2. 3.7 handle component held in the hand during use, one end forming the connection to the blade 3.8 hook-on fitting fitting on a laryngoscope handle that allows connection of a detachable blade to the handle and that incorporates an electrical contact or optical pathway 3

48、.9 lamp electrical filament bulb intended to provide illumination during laryngoscopy 3.10 lamp base metallic outer housing of the lamp, which provides electrical contact and mechanical engagement of the lamp by means of a male screw thread 3.11 locking mechanism mechanism that retains the blade in

49、the operating position BS EN ISO 7376:August 2009ISO 7376:2009(E) ISO 2009 All rights reserved 33.12 operating position position of the engaged blade and handle when the laryngoscope is ready for use 3.13 single-piece laryngoscope laryngoscope with a handle and non-detachable blade 3.14 socket component with a female screw thread attached to a laryngoscope blade and intended to provide electrical contact and mechanical engagement with a lamp 4 General requirements 4.1 Design 4.1.1 Except for a single-piece laryngoscope, the lamp sha