EN ISO 7376:2003

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

Migrated from Progress Sheet (TC Comment) (2000-07-10): Revision of EN 1819:1997 (TC Res 327/1999) (CC/000128) ++ Contact Trevro x 850 when progressing this through any stage

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

Diese Internationale Norm legt allgemeine Anforderungen an Laryngoskope und die wichtigsten Maße für Griff und Lampe von Laryngoskopen mit Einhängeverbindung fest.
Sie gilt nur für Geräte, die über eine elektrische 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 durch den gleichen Oberbegriff bekannten chirurgischen Instrumente.
Diese Internationale Norm gilt nicht für
a) die Spatelform und die Griffausführung, mit Ausnahme der allgemeinen Anforde-rungen und der Festlegungen, die die Austauschbarkeit des Anschlusses zwischen Spatel und Griff betreffen;
b) die Messung und Spezifikation der Lichtstärke der Lampen;
c) flexible Laryngoskope oder Laryngoskope für die Chirurgie;
d) netzstrombetriebene Laryngoskope;
e) 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)

Anestezijska in dihalna oprema - Laringoskopi za trahealno intubacijo (ISO 7376:2003)

General Information

• Status: Withdrawn
• Publication Date: 14-Dec-2003
• Withdrawal Date: 07-Apr-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: 08-Apr-2009
• Completion Date: 08-Apr-2009
• 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 7376:2004 - Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2003)

Relations

• Replaces: EN 1819:1997 - Laryngoscopes for tracheal intubation - Particular requirements
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 7376:2009 - Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2003)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2004
1DGRPHãþD
SIST EN 1819:2000
Anestezijska in dihalna oprema - Laringoskopi za trahealno intubacijo (ISO
7376:2003)
Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO
7376:2003)
Anästhesie- und Beatmungsgeräte - Laryngoskope für Trachealintubation (ISO
7376:2003)
Matériel d'anesthésie et de réanimation respiratoire - Laryngoscopes pour intubation
trachéale (ISO 7376:2003)
Ta slovenski standard je istoveten z: EN ISO 7376:2003
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
December 2003
ICS 11.040.55 Supersedes EN 1819:1997
English version
Anaesthetic and respiratory equipment - Laryngoscopes for
tracheal intubation (ISO 7376:2003)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Laryngoskope für
Laryngoscopes pour intubation trachéale (ISO 7376:2003) Trachealintubation (ISO 7376:2003)
This European Standard was approved by CEN on 2 December 2003.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7376:2003 E
worldwide for CEN national Members.

CORRECTED  2004-04-14
Foreword
This document (EN ISO 7376:2003) 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 June 2004, and conflicting national
standards shall be withdrawn at the latest by June 2004.

This document supersedes EN 1819:1997.

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(s).
For relationship with EU Directive(s), see informative Annex ZB, 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, Czech
Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and
the United Kingdom.
Endorsement notice
The text of ISO 7376:2003 has been approved by CEN as EN ISO 7376:2003 without any
modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications

This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).

NOTE Where an International Publication has been modified by common modifications, indicated
by (mod.), the relevant EN/HD applies.

Publication Year Title EN Year

ISO 10993-1 1997 Biological evaluation of medical EN ISO 10993-1 1997
devices - Part 1: Evaluation and testing

ANNEX ZB
(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 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 Communities 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 ZB.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.
WARNING: Other requirements and other EU Directives may be applicable to the product(s)
falling within the scope of this standard.

TABLE ZB.1 - Correspondence between this European Standard and EU Directives

Clause/subclause of this Comments
Corresponding Essential
European Standard
Requirement of Directive
4.1 1, 2, 12.9
4.2.1 1, 2, 7.1, 7.3
4.2.2 1, 2, 9.2 As per CEN
4.2.3 1, 2, 7.1, 7.3, 9.2
4.2.4 1, 2
4.3 4, 5, 7.1, 7.2, 8.6, 9.2,
4.3.a 4, 5, 7.2
4.3.b 4, 5, 7.2
4.3.c 4, 5, 7.2
4.4 2, 12.7.4, 12.8.2
5.1 1, 2, 3, 9.2
5.2.1.1 3, 9.2
5.2.1.2 3, 9.2
5.2.2.1 3, 12.7.4
5.2.2.2 3, 12.7.4
5.2.2.3 3, 12.7.4
5.2.2.4 3, 12.7.4
5.2.3 3, 12.7.4
5.3.1 2, 3
5.3.2 2, 3
5.3.3 2, 3
5.4 3, 12.7.1
5.5.1 3, 12.7.1
5.5.2 3, 12.7.1
5.6 3, 12.7.1
6.1.1 3, 12.7.4
6.1.2 3, 9.2
6.1.3 3, 12.7.4
6.1.4 7.5, 7.6
6.1.5 3, 12.7.4
6.2.1 2
6.2.2 2
7.1 2
7.2 2, 3, 12.7.4
8.1.1 3, 12.7.1
8.1.2 2, 3, 12.7.1
8.1.3 3, 12.7.4
8.1.4 7.1
8.2.1 2, 12.7.1
8.2.2 2, 12.7.1
9.1 1, 8.1, 13.6(h)
9.2 2, 8.1, 13.6(h)
10.1 13.1, 13.3(a), 13.6(a)
10.2 13.1, 13.3(a)
10.3 a 13.1, 13.3(b)
10.3 b 13.1, 13.3(b)
10.3 c 2, 3
10.3 d 2, 3, 12.9, 13.3(b)
10.3 e 2, 13.2
10.4 2, 13.5
10.5 2, 13.2
10.6 a 13.3(d), 13.5
10.6 b 3, 8.3, 8.4, 8.7, 13.3 (c)
10.6 c 8.3, 8.7, 13.1, 13.3(f)
11 2, 13.1, 13.2, 13.3(i, j, k), 13.6(b)
11 a) 13.6(d)
11 b) 3, 8.1, 13.3(m), 13.6(h, i)
11 c) 2, 6, 13.6(h)
11 d) 13.6(g, i)
11 e) 12.2, 12.6(d)
11 f) 3, 12.2, 12.3
11 g) 7.5
11 h) 2, 13.3(j, k), 13.4, 13.6(h)
11 i) 4, 9.2, 13.6(f)
11 j) 4, 5, 13.3(c, f), 13.6(d, h)
11 k) 4, 13.6(d)
11 l) 2, 6, 12.7.5
A 1,2,7.1, 12.7.1
B 13.1
C
Annex ZB Bibliography
INTERNATIONAL ISO
STANDARD 7376
First edition
2003-12-15
Anaesthetic and respiratory equipment —
Laryngoscopes for tracheal intubation
Matériel d'anesthésie et de réanimation respiratoire — Laryngoscopes
pour intubation trachéale
Reference number
ISO 7376:2003(E)
©
ISO 2003
ISO 7376:2003(E)
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ISO 7376:2003(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 1
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 . 3
5.1 Blade and handle hook-on fittings . 3
5.2 Handle fittings . 3
5.3 Blade fittings . 6
5.4 Engagement. 6
5.5 Operating position . 6
5.6 Disengagement . 6
6 Lamp for conventional blade . 8
6.1 Lamp and lamp base contact. 8
6.2 Screw threads for lamps . 8
7 Lamps for fibre-illuminated laryngoscopes . 10
8 Sockets for conventional blades. 10
8.1 Dimensions and centre contact. 10
8.2 Internal screw threads. 10
9 Cleaning, disinfection and sterilization . 10
10 Marking and labelling . 10
11 Accompanying documents . 11
Annex A (normative) Test method for security of lamp contact . 12
Annex B (normative) Blade markings . 13
Annex C (informative) Rationale .14
Bibliography .
...