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CEN

EN ISO 7376:2020

(Main)

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

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
Publication Date
22-Sep-2020
Withdrawal Date
30-Mar-2021
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215/WG 4 - Tracheal tubes and other equipment
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
23-Sep-2020
Completion Date
23-Sep-2020
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
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 7376:2020 - Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2020)

Relations

Replaces
EN ISO 7376:2009 - Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2003)
Effective Date
15-Jun-2016
Amended By
EN ISO 7376:2020/prA1 - Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation - Amendment 1: Clarification about optical output and illumination requirements (ISO 7376:2020/DAmd1:2024)
Effective Date
14-Jun-2023

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

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.

Contents Page
European foreword . 3

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.

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
ISO 7376:2020(E)
© 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

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 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 prepare
...

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EN ISO 5362:2024(Main)
Anaesthetic and respiratory equipment - Anaesthetic reservoir bags (ISO 5362:2024)
SIST EN ISO 5362:2024

This document specifies requirements for anaesthetic reservoir bags for use with anaesthetic and ventilator breathing systems. It includes requirements for the design of the neck, size designation and elasticity.
This document is not applicable to special-purpose bags, for example bellows, self-inflating bags and bags for use with anaesthetic gas scavenging systems.
The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190). All the common requirements that appear in the general standard for airway devices have been removed from this document.

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EN ISO 16571:2024(Main)
Systems for evacuation of plume generated by medical devices (ISO 16571:2024)
SIST EN ISO 16571:2024

This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices.
 This document applies to all types of plume evacuation systems (PESs), including
a)       portable;
b)       mobile;
c)        stationary, including dedicated central pipelines;
d)       PESs integrated into other equipment;
e)       PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic)
This document applies to all healthcare facilities where PESs are used, including, but not limited to
a)       surgical facilities;
b)       medical offices;
c)        cosmetic treatment facilities;
d)       medical teaching facilities;
e)       dental clinics;
f)         veterinary facilities.
This document provides guidance on the following aspects of PESs:
a)       importance;
b)       purchasing;
c)        design;
d)       manufacture;
e)       documentation;
f)         function;
g)       performance;
h)       installation;
i)         commissioning;
j)         testing;
k)       training;
l)         use;
m)     risk assessment;
n)       servicing;
o)       maintenance.
This document does not apply to the following:
a)       anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;
b)       medical vacuum systems which are covered in ISO 7396-1;
c)        heating, ventilation, and air-conditioning (HVAC) systems;
d)       aspects of laser safety other than airborne contamination; and
e)       aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.

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EN ISO 15002:2024(Main)
Flow control devices for connection to a medical gas supply system (ISO 15002:2023)
SIST EN ISO 15002:2024

This document specifies requirements for flow control devices that can be connected by the user either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure hose assembly conforming with ISO 5359 to:
a)    a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016;
b)    the pressure outlet of a regulator conforming with ISO 10524-1:2018; or
c)    to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3 (see 5.2 gas inlets).
This document applies to the following types of flow control devices (FCDs):
a)    flowmeters;
b)    flowgauge FCDs; and
c)    fixed orifice FCDs.
NOTE       Flow control devices that are classed as medical electrical equipment can be subject to additional requirements of IEC 60601-1.
This document applies to flow control devices for the following gases:
—    oxygen;
—    oxygen 93 %;
—    nitrous oxide;
—    medical air;
—    carbon dioxide;
—    oxygen/nitrous oxide mixture 50/50 (% volume fraction);
—    oxygen-enriched air;
—    helium;
—    xenon; and
—    specified mixtures of the gases listed above.
NOTE Flow control devices can be available for other gases.
This document does not apply to flow control devices that are:
a)    for use with gases for driving surgical tools;
b)    an integral part of a regulator (see ISO 10524-1:2018); or
c)           an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 10524-3).

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EN ISO 80601-2-55:2018/A1:2023(Amendment)
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/Amd 1:2023)
SIST EN ISO 80601-2-55:2018/A1:2024
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