DIN EN ISO 7376-2010 Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376 2009) German version EN ISO 7376 2009《麻醉和呼吸设备 气管插管用喉镜(ISO 7376-2000) 德文.pdf

1、January 2010DEUTSCHE NORM English price group 16No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.10!$L“1569141ww

2、w.din.deDDIN EN ISO 7376Anaesthetic and respiratory equipment Laryngoscopes for tracheal intubation (ISO 7376:2009)English version of DIN EN ISO 7376:2010-01Ansthesie- und Beatmungsgerte Laryngoskope fr Trachealintubation (ISO 7376:2009)Englische Fassung DIN EN ISO 7376:2010-01SupersedesDIN EN ISO 7

3、376:2009-08See start of validitywww.beuth.deDocument comprises 37 pagesDIN EN ISO 7376:2010-01 2 Start of validity This standard takes effect on 1 January 2010. DIN EN ISO 7376:2009-08 may be used in parallel until 21 March 2010. National foreword This standard has been prepared by Technical Committ

4、ee ISO/TC 121 “Anaesthetic and respiratory equipment” (Secretariat: BSI, United Kingdom) in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” (Secretariat: BSI, United Kingdom). The responsible German body involved in its preparation was the Normenausschuss Re

5、ttungsdienst und Krankenhaus (Rescue Services and Hospital Standards Committee), Working Committee NA 053-03-02 AA Trachealtuben. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 4135 DIN EN ISO 4135 ISO 10993-1 DIN EN ISO 10993-1 IEC 60

6、601-1 DIN EN 60601-1 (VDE 0750 Part 1) Amendments This standard differs from DIN EN ISO 7376:2009-08 as follows: a) It has been clarified in the scope that this standard is not applicable to video laryngoscopes designed to work with external video systems. b) Requirements for materials have been rev

7、ised. c) Requirements for illumination (5.1), blade strength and rigidity (5.2) and the corresponding test methods (Annex B) have been included. d) Requirements for marking and labelling (10) and accompanying documents (11) have been revised. e) Blade size markings (informative Annex C) have been re

8、vised. f) Laryngoscope blade designs are given in an informative Annex D. g) The standard has been editorially revised. Previous editions DIN EN ISO 7376: 2004-05, 2009-08 DIN EN 1819: 1998-01 DIN 58870: 1989-05 DIN EN ISO 7376:2010-01 3 National Annex NA (informative) Bibliography DIN EN ISO 4135,

9、Anaesthetic and respiratory equipment Vocabulary DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN 60601-1 (VDE 0750 Part 1), Medical electrical equipment Part 1: General requirements for safety DIN EN ISO 7376:2010-01

10、4 This page is intentionally blank EUROPEAN 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 - Laryngoscopes for tracheal intubation (ISO 7376:2009) Matriel danesthsie et de ranimati

11、on 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 members are bound to comply with the CEN/CENELEC Internal Regulations which stip

12、ulate 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 Management Centre or to any CEN member. This European Standard

13、 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 the same status as the official versions. CEN members are the national standa

14、rds 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, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United King

15、dom. 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 reserved worldwide for CEN national Members. Ref. No. EN ISO 7376:2009: ECon

16、tents 2 DIN EN ISO 7376:2010-01 EN ISO 7376:2009 (E) PageForeword .3 Introduction.4 1 Scope5 2 Normative references5 3 Terms and definitions .6 4 General requirements .7 4.1 Design.7 4.2 Materials for laryngoscope blades and single-piece laryngoscopes 7 4.3 Environmental requirements7 4.4 Internal e

17、lectrical power source 7 5 Performance requirements.8 5.1 Illumination 8 5.2 Blade strength and rigidity.8 5.3 Blade and handle hook-on fittings 8 5.4 Handle fittings8 5.5 Blade fittings11 5.6 Engagement .11 5.7 Operating position.11 5.8 Disengagement11 6 Lamp for conventional blade .13 6.1 Lamp and

18、 lamp base contact .13 6.2 Screw thread for lamps.14 7 Lamps for fibre-illuminated laryngoscopes15 8 Sockets for conventional blades .15 8.1 Dimensions and centre contact .15 8.2 Internal screw threads 15 9 Cleaning, disinfection and sterilization.15 10 Marking and labelling16 11 Accompanying docume

19、nts 16 Annex A (normative) Test method for lamp contact security 18 Annex B (normative) Test methods for strength, rigidity and illumination 19 Annex C (informative) Blade size markings .21 Annex D (informative) Laryngoscope blade designs 22 Annex E (informative) Rationale for inclusion of certain r

20、equirements29 Bibliography31 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC .32 Foreword This document (EN ISO 7376:2009) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment“ in collab

21、oration 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 the latest by February 2010, and conf

22、licting 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 or all such patent rights. This docume

23、nt 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 informative Annex ZA, which is an integ

24、ral 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, Finland, France, Germany, Greece, Hungary

25、, 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 ISO 7376:2009 without any modification

26、. 3 EN ISO 7376:2009 (E) DIN EN ISO 7376:2010-01Introduction This International 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 reusab

27、le 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 larynx during use is either a lam

28、p 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 the most appropriate instrument

29、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. 4 DIN EN ISO 7376:2010-01 EN ISO 7376:2009 (E) 1 Scope This International Standard gives ge

30、neral requirements for laryngoscopes 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 i

31、lluminating the larynx, since 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 sur

32、gery, laryngoscopes powered 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

33、 other International Standards. 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) app

34、lies. ISO 5864, ISO inch screw 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

35、 manufacturer with medical devices 5 EN ISO 7376:2009 (E) DIN EN ISO 7376:2010-013 Terms and 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 h

36、ook-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 incorporating a lamp, positioned to provide direct illumination of the larynx during use, and having an elec

37、trical 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-illuminat

38、ed blade blade incorporating optical fibres to transmit light from a source to illuminate 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 detac

39、hable blade to the handle and that incorporates an electrical contact or optical pathway 3.9 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 b

40、y means of a male screw thread 3.11 locking mechanism mechanism that retains the blade in the operating position 6 DIN EN ISO 7376:2010-01 EN ISO 7376:2009 (E) 3.12 operating position position of the engaged blade and handle when the laryngoscope is ready for use 3.13 single-piece laryngoscope laryn

41、goscope 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 s

42、hall light when the blade and handle are placed in the operating position. 4.1.2 A single-piece laryngoscope shall have a switch that latches in both the ON and OFF positions to control power to the lamp, and that is marked accordingly. 4.2 Materials for laryngoscope blades and single-piece laryngos

43、copes Materials shall satisfy appropriate biological safety testing, as specified in ISO 10993-1, i.e. external communicating, tissue/bone/dentin communicating, and of less than 24 hour duration. 4.3 Environmental requirements 4.3.1 A laryngoscope component, other than a battery, shall be capable of

44、 meeting the requirements of Clauses 5, 6, 7, 8, 10 and 11 after being exposed for 14 days in its storage and/or transport packaging in environmental conditions over the following ranges: a) ambient temperature range of 40 C to +70 C; b) relative humidity up to 95 % non-condensing; c) atmospheric pr

45、essure range of 50 kPa to 106 kPa. NOTE See Annex E for the rationale for inclusion of these requirements. 4.3.2 A laryngoscope component, other than a battery, shall be capable of functioning in its intended use after being exposed for 14 days in its storage and/or transport packaging in environmen

46、tal conditions. 4.3.3 Compliance with 4.3.1 and 4.3.2 shall be checked by functional testing. 4.4 Internal electrical power source If the handle is intended for use with rechargeable cells, a current-limiting device that prevents more than three times normal current flowing in a single fault conditi

47、on shall be incorporated into the handle. NOTE See Annex E for the rationale for inclusion of this requirement. 7 EN ISO 7376:2009 (E) DIN EN ISO 7376:2010-015 Performance requirements 5.1 Illumination 5.1.1 The manufacturer of the detachable laryngoscope blade shall specify the design of the handle

48、 to be used with the blade. 5.1.2 Except for a single-piece laryngoscope, the lamp shall light when the blade and handle are placed in the operating position. 5.1.3 When tested in accordance with Annex B, the illumination shall have the following characteristics. a) The distance between the upper il

49、lumination edge and the blade tip on the screen shall be less than 3 mm. b) The distance between the upper and lower illumination edges shall be greater than 30 mm but less than 80 mm. c) The distance between the right edge and the centre of the blade tip shall be greater than 25 mm but less than 50 mm. d) The distance between the left edge and the centre of the blade tip shall be greater than 25 mm but less than 50 mm. 5.1.4 When tested in accordance with B.2, illumination shall exceed 500 lx for at least 10 min. This requirement for the