Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2020)

This document, which is device-specific, specifies requirements for laryngoscopes with non-flexible
blades, with internal battery-operated power sources, used for illuminating the larynx during
intubation. It also specifies critical dimensions for those handles and laryngoscope blades with
interchangeable hook‐on fittings.
It is not applicable to the following:
— flexible laryngoscopes;
— laryngoscopes designed for surgery;
— laryngoscopes powered from mains electricity supply;
— laryngoscopes connected by light‐transmitting cables to external light sources;
— video laryngoscopes designed to work with an external, integral or attached video system.

Anästhesie- und Beatmungsgeräte - Laryngoskope für Trachealintubation (ISO 7376:2020)

Dieses gerätespezifische Dokument legt die Anforderungen für Laryngoskope mit nicht-flexiblen Spateln mit integrierten, batteriebetriebenen Energiequellen fest, die zur Beleuchtung des Kehlkopfes während der Intubation verwendet werden. Zudem legt es wichtige Maße für Griffe und Laryngoskop-Spatel mit austauschbaren Einhängeanschlüssen fest.
Das Dokument gilt nicht für:
- flexible Laryngoskope;
- Laryngoskope für die Chirurgie;
- netzstrombetriebene Laryngoskope;
- Laryngoskope, die mittels Lichtleiter an externe Lichtquellen angeschlossen sind;
- Videolaryngoskope, die zum Arbeiten mit externen, integrierten oder angebundenen Videosystemen vorgesehen sind.

Matériel d'anesthésie et de réanimation respiratoire - Laryngoscopes pour intubation trachéale (ISO 7376:2020)

Le présent document, spécifique d'un dispositif, spécifie les exigences relatives aux laryngoscopes à lames non flexibles, ayant une source interne d'alimentation électrique par batteries permettant d'éclairer le larynx pendant l'intubation. Il spécifie également les dimensions critiques de ces manches et lames de laryngoscope avec des mécanismes d'enclenchement interchangeables.
Il n'est pas applicable:
— aux laryngoscopes flexibles;
— aux laryngoscopes conçus pour la chirurgie;
— aux laryngoscopes alimentés par le réseau électrique;
— aux laryngoscopes raccordés par câbles de transmission de la lumière à des sources lumineuses externes;
— aux laryngoscopes vidéo conçus pour fonctionner avec un système vidéo externe, intégré ou attaché.

Anestezijska in dihalna oprema - Laringoskopi za trahealno intubacijo (ISO 7376:2020)

General Information

Status
Published
Public Enquiry End Date
24-Jun-2018
Publication Date
11-Oct-2020
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
02-Oct-2020
Due Date
07-Dec-2020
Completion Date
12-Oct-2020

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SLOVENSKI STANDARD
SIST EN ISO 7376:2020
01-november-2020
Nadomešča:
SIST EN ISO 7376:2010
Anestezijska in dihalna oprema - Laringoskopi za trahealno intubacijo (ISO
7376:2020)

Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO

7376:2020)
Anästhesie- und Beatmungsgeräte - Laryngoskope für Trachealintubation (ISO
7376:2020)

Matériel d'anesthésie et de réanimation respiratoire - Laryngoscopes pour intubation

trachéale (ISO 7376:2020)
Ta slovenski standard je istoveten z: EN ISO 7376:2020
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 7376:2020 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 7376:2020
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SIST EN ISO 7376:2020
EN ISO 7376
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2020
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 7376:2009
English Version
Anaesthetic and respiratory equipment - Laryngoscopes
for tracheal intubation (ISO 7376:2020)

Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Laryngoskope für

Laryngoscopes pour intubation trachéale (ISO Trachealintubation (ISO 7376:2020)
7376:2020)
This European Standard was approved by CEN on 26 June 2020.

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-CENELEC 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-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7376:2020 E

worldwide for CEN national Members.
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SIST EN ISO 7376:2020
EN ISO 7376:2020 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 7376:2020
EN ISO 7376:2020 (E)
European foreword

This document (EN ISO 7376:2020) 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 March 2021, and conflicting national standards shall

be withdrawn at the latest by March 2021.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 7376:2009.

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,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 7376:2020 has been approved by CEN as EN ISO 7376:2020 without any modification.

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SIST EN ISO 7376:2020
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SIST EN ISO 7376:2020
INTERNATIONAL ISO
STANDARD 7376
Third edition
2020-08
Anaesthetic and respiratory
equipment — Laryngoscopes for
tracheal intubation
Matériel d'anesthésie et de réanimation respiratoire —
Laryngoscopes pour intubation trachéale
Reference number
ISO 7376:2020(E)
ISO 2020
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SIST EN ISO 7376:2020
ISO 7376:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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SIST EN ISO 7376:2020
ISO 7376:2020(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 *Scope .............................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 *Terms and definitions .................................................................................................................................................................................. 1

4 General requirements ..................................................................................................................................................................................... 2

5 Materials ....................................................................................................................................................................................................................... 2

6 Design requirements ........................................................................................................................................................................................ 2

6.1 General .......................................................................................................................................................................................................... 2

6.2 *Environmental conditions .......................................................................................................................................................... 2

7 Performance requirements ....................................................................................................................................................................... 3

7.1 Handles ......................................................................................................................................................................................................... 3

7.1.1 *Electrical safety .............................................................................................................................................................. 3

7.1.2 Electrical contact ............................................................................................................................................................. 3

7.1.3 Dimensions ........................................................................................................................................................................... 3

7.1.4 *Optical output .................................................................................................................................................................. 5

7.1.5 *Strength ................................................................................................................................................................................. 5

7.2 Laryngoscope blades .......................................................................................................................................................................... 5

7.2.1 Dimensions ........................................................................................................................................................................... 5

7.2.2 *Rigidity ................................................................................................................................................................................... 5

7.2.3 *Strength ................................................................................................................................................................................. 5

7.2.4 *Illumination ....................................................................................................................................................................... 6

7.2.5 Electrical interface.......................................................................................................................................................... 6

7.3 Hinged combinations .......................................................................................................................................................................... 6

7.4 Single-piece laryngoscopes ........................................................................................................................................................... 7

8 Cleaning, disinfection and sterilization ........................................................................................................................................ 8

9 Information supplied by the manufacturer ............................................................................................................................. 8

9.1 General ........................................................................................................................................................................................................... 8

9.2 Marking ......................................................................................................................................................................................................... 8

9.3 Designated size for the intended patient demographic ....................................................................................... 8

9.4 Instructions for use ............................................................................................................................................................................. 8

Annex A (informative) Rationale ...........................................................................................................................................................................10

Annex B (normative) Test method for illumination, strength and rigidity ...............................................................12

Annex C (informative) Common terms for parts of a laryngoscope blade .................................................................15

Bibliography .............................................................................................................................................................................................................................16

© ISO 2020 – All rights reserved iii
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SIST EN ISO 7376:2020
ISO 7376:2020(E)
Foreword

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 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 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

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 identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory

equipment, Subcommittee SC 2, Airways and related equipment, in collaboration with the European

Committee for Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic

equipment, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna

Agreement).

This third edition cancels and replaces the second edition (ISO 7376:2009), which has been technically

revised.
The main changes compared to the previous edition are as follows:
— the layout has changed to align with ISO 18190:2016;

— removal of the requirements for filament luminaires, which are now almost entirely replaced by LED

luminaires;

— additional requirement to prevent current surges from batteries with a rated voltage exceeding 3,6 V;

— test methods have been rationalized;
— each requirement is now followed by a conformance requirement;
— the strength requirement has been extended to handles;

— environmental conditions during transport, storage and normal use are now referenced to

IEC 60601-1-12.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved
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SIST EN ISO 7376:2020
ISO 7376:2020(E)
Introduction

Laryngoscopes are manufactured in several forms. There are, for example, single-piece laryngoscopes,

non-user-detachable hinged laryngoscope blades, or detachable hinged laryngoscope blades and handles.

In the latter case, the light source for illuminating the larynx during use is either a luminaire fixed in

the laryngoscope blade or a luminaire in the handle with a light guide in the laryngoscope blade. The

minimum light output from the laryngoscope is specified.

Laryngoscope blades are defined and marked by size designation (see Table 2), suitable for the patient

demographic for which they are designed and ranges from small, premature infants to extra-large

adults. Because there are so many variations, the length of laryngoscope blade is disclosed on the

packaging to allow an informed decision by the operator to select the most appropriate instrument for

intubation. Annex B describes test methods for illumination, rigidity and strength.

Throughout this document the following print types are used:
— Requirements and definitions: roman type;
— Conformance tests: italic type;

— Informative material appearing outside of tables, such as notes, examples and references: smaller

type. The Normative text of tables is also in smaller type;
— Terms defined in Clause 3: italics.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates

that there is guidance or rationale related to that item in Annex A.
© ISO 2020 – All rights reserved v
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SIST EN ISO 7376:2020
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SIST EN ISO 7376:2020
INTERNATIONAL STANDARD ISO 7376:2020(E)
Anaesthetic and respiratory equipment — Laryngoscopes
for tracheal intubation
1 *Scope

This document, which is device-specific, specifies requirements for laryngoscopes with non-flexible

blades, with internal battery-operated power sources, used for illuminating the larynx during

intubation. It also specifies critical dimensions for those handles and laryngoscope blades with

interchangeable hook‐on fittings.
It is not applicable to the following:
— flexible laryngoscopes;
— laryngoscopes designed for surgery;
— laryngoscopes powered from mains electricity supply;

— laryngoscopes connected by light-transmitting cables to external light sources;

— video laryngoscopes designed to work with an external, integral or attached video system.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements 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 4135, Anaesthetic and respiratory equipment — Vocabulary

ISO 18190:2016, Anaesthetic and respiratory equipment — General requirements for airways and related

equipment

IEC 60601-1-12:2014, Medical electrical equipment — Part 1-12: General requirements for basic safety and

essential performance — Collateral Standard: Requirements for medical electrical equipment and medical

electrical systems used in the emergency medical services environment
3 *Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 4135, ISO 18190 and the

following apply:
ISO
...

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