EN ISO 7376:2009

Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2003)

ISO 7376:2009 gives general 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 illuminating 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 surgery, 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.

Anästhesie- und Beatmungsgeräte - Laryngoskope für Trachealintubation (ISO 7376:2003)

Diese Internationale Norm legt allgemeine Anforderungen an zur Intubation verwendete Laryngoskope und die wichtigsten Maße für Griff und Lampe von Laryngoskopen mit Einhängeverbindung fest. Sie behandelt außerdem die Austauschbarkeit von Spateln und Griffen.
Sie gilt nur für Geräte, die über eine interne batteriebetriebene Stromquelle zur Beleuchtung des Kehlkopfes verfügen, da für Geräte, die an das Stromnetz oder externe Stromquellen angeschlossen sind, höhere Anforderungen an die elektrische Sicherheit gelten können.
Diese Internationale Norm gilt nicht für die mit dem gleichen Oberbegriff bezeichneten chirurgischen Instrumente.
Diese Internationale Norm gilt nicht für
   flexible Laryngoskope oder Laryngoskope für die Chirurgie;
   netzstrombetriebene Laryngoskope;
   Laryngoskope, die mittels Lichtleiter an externe Lichtquellen angeschlossen sind.
ANMERKUNG   Für Geräte, die durch Lichtführungen an externe Lichtquellen angeschlossen sind, können andere Internationale Normen für Endoskope anwendbar sein.

Matériel d'anesthésie et de réanimation respiratoire - Laryngoscopes pour intubation trachéale (ISO 7376:2003)

L'ISO 7376:2009 spécifie les exigences générales relatives aux laryngoscopes employés pour intubation et les dimensions critiques du manche et de la lampe sur les laryngoscopes à enclenchement. Elle définit également l'interchangeabilité entre lames et manches.
L'ISO 7376:2009 s'applique uniquement aux instruments ayant une source interne d'alimentation électrique par batteries permettant d'éclairer le larynx dans la mesure où les exigences de sécurité électrique peuvent être plus strictes pour les instruments reliés au réseau ou à des sources d'alimentation externes.
L'ISO 7376:2009 ne s'applique pas aux instruments chirurgicaux connus sous le même nom générique, ni aux laryngoscopes flexibles ou aux laryngoscopes conçus pour la chirurgie, ni aux laryngoscopes alimentés par le réseau électrique, ni aux laryngoscopes raccordés par câbles de transmission de la lumière à des sources lumineuses externes et ni aux laryngoscopes vidéo conçus pour fonctionner avec un système vidéo externe.

Anestezijska in dihalna oprema - Laringoskopi za trahealno intubacijo (ISO 7376:2009)

Ta mednarodni standard podaja splošne zahteve za laringoskope, ki se uporabljajo za intubacijo, in določa kritične mere ročajev in žarnic na laringoskopih za pritrditev. Obravnava tudi medsebojno zamenljivost rezil in ročajev. Velja samo za instrumente za osvetljevanje grla z notranjim napajanjem na baterije, saj so zahteve za električno varnost za instrumente, ki se povezujejo z omrežnim napajanjem ali zunanjim virom energije, lahko strožje.

General Information

• Status: Withdrawn
• Publication Date: 07-Apr-2009
• Withdrawal Date: 14-Aug-2009
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 15-Aug-2009
• Completion Date: 15-Aug-2009
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 7376:2010 - Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009)

Relations

• Replaces: EN ISO 7376:2003 - Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2003)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 7376:2020 - Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2020)
• Effective Date: 15-Jun-2016

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2010
1DGRPHãþD
SIST EN ISO 7376:2009
Anestezijska in dihalna oprema - Laringoskopi za trahealno intubacijo (ISO
7376:2009)
Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO
7376:2009)
Anästhesie- und Beatmungsgeräte - Laryngoskope für Trachealintubation (ISO
7376:2009)
Matériel d'anesthésie et de réanimation respiratoire - Laryngoscopes pour intubation
trachéale (ISO 7376:2009)
Ta slovenski standard je istoveten z: EN ISO 7376:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 7376
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2009
ICS 11.040.10 Supersedes EN ISO 7376:2009, April
English Version
Anaesthetic and respiratory equipment - Laryngoscopes for
tracheal intubation (ISO 7376:2009)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Laryngoskope für
Laryngoscopes pour intubation trachéale (ISO 7376:2009) 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 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 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 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, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7376:2009: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative)  Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

Foreword
This document (EN ISO 7376:2009) has been prepared by Technical Committee ISO/TC 121 "Anaesthetic
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 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 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 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, Finland, 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 ISO 7376:2009 without any modification.
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 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 Official 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 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 Essential requirements (ERs) of EU
Qualifying remarks/Notes
International Standard Directive 93/42/EEC
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, 3
5.5.2 2, 3
5.5.3 2, 3
5.5.4 3
5.6 12.7.1
Clause(s)/subclause(s) of this Essential requirements (ERs) of EU
Qualifying remarks/Notes
International Standard Directive 93/42/EEC
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, 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) 13.6 (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: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this International standard.
INTERNATIONAL ISO
STANDARD 7376
Second edition
2009-08-15
Anaesthetic and respiratory equipment —
Laryngoscopes for tracheal intubation
Matériel d'anesthésie et de réanimation respiratoire — Laryngoscopes
pour intubation trachéale
Reference number
ISO 7376:2009(E)
©
ISO 2009
ISO 7376:2009(E)
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ISO 7376:2009(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms 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 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 conventional 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, rigidity 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 .
...