ISO 7376-2:2025
(Main)Anaesthetic and respiratory equipment — Part 2: Video laryngoscopes
Anaesthetic and respiratory equipment — Part 2: Video laryngoscopes
This document specifies requirements for electrically powered video laryngoscopes that comprise a handle, a rigid blade, a light source, a camera and an image display that provides a clear view of the larynx to assist tracheal intubation. This document specifies requirements for accessories that are essential to the function of the video laryngoscope. This document is not applicable to the following: — laryngoscopes without a camera or image display (see ISO 7376); — endoscopes (see ISO 8600-1); — laryngoscopes designed for surgery; — image quality requirement for third party display screens, for example a phone or computer monitor, and which are not supplied by the video laryngoscope manufacturer as part of the video laryngoscope system.
Équipement anesthésique et respiratoire — Partie 2: Vidéolaryngoscopes
General Information
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International
Standard
ISO 7376-2
First edition
Anaesthetic and respiratory
2025-09
equipment —
Part 2:
Video laryngoscopes
Équipement anesthésique et respiratoire —
Partie 2: Vidéolaryngoscopes
Reference number
© ISO 2025
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
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 3
4.1 General .3
4.2 Risk management .3
5 Materials . 4
5.1 General .4
5.2 Exterior / External surfaces .4
6 Design requirements . 4
6.1 General .4
6.2 Components .4
6.3 Mechanical requirements .5
6.3.1 VL strength .5
6.3.2 Rigidity .6
6.3.3 Drop test .6
6.3.4 Illumination .6
6.4 Image quality .7
6.4.1 Limiting resolution .7
6.4.2 Distortion .7
6.4.3 Latency .7
6.4.4 Contrast .7
6.4.5 Image display .7
6.4.6 Field of view (FOV) .8
6.4.7 Camera lens condensation .8
6.5 Temperature .9
6.6 System communication .9
6.7 Requirements for VLs for emergency medical services .9
6.8 Transportation and storage .9
6.9 Batteries .9
7 Cleaning, disinfection and sterilization . 9
8 Information supplied by the manufacturer . 10
8.1 General .10
8.2 Marking .10
8.3 Reusable .10
8.4 Instructions for use (IFU) . .10
Annex A (informative) Rationale .12
Annex B (normative) Test method for illumination, strength and rigidity .15
Annex C (normative) Test method for determining the field of view . 17
Annex D (informative) Hazard identification for risk assessment .18
Annex E (informative) Video laryngoscope designs .20
Bibliography .22
iii
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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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 ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee
SC 2, Airway devices and related equipment.
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
Introduction
This document provides the essential performance and safety requirements for video laryngoscopes. Video
laryngoscopes are tools used to facilitate endotracheal intubation. A rigid video laryngoscope holds and
shapes the anatomical structures providing access to the trachea, not dependent on a line of sight. Video
laryngoscopes are designed to provide a view of the larynx and entrance into the trachea.
Video laryngoscopes have been developed to provide the user with a view of the larynx via a camera and an
image display unit. The use of video laryngoscopes is increasing in clinical practice and they have become an
important tool for tracheal intubation. Video laryngoscopes are particularly useful for difficult intubations
and for reducing the risk of oesophageal intubation. There is a wide variety of video laryngoscope designs
and basic performance criteria need to be established to enhance patient safety.
The video laryngoscope incorporates a light source and miniature camera to view the larynx during
the procedure of laryngoscopy. The image is displayed on a screen. Common use environments of video
laryngoscopes include: operating rooms, emergency rooms, intensive care units, and in the pre-hospital
setting. Typical users include: health care providers who intubate such as anaesthesiologists, respiratory
therapists, emergency response physicians, intensive care unit physicians, paramedics, certified nurse
anaesthetists and anaesthesia assistants.
This document is intended to provide a device specific standard focused on video laryngoscopes. Video
laryngoscopes have evolved from direct laryngoscopes but, in contrast to direct laryngoscopes providing
a direct view, video laryngoscopes provide an indirect view of the larynx made visible on an image display.
Video laryngoscopes utilize digital imaging technology and can require less force to visualize the larynx
compared to direct laryngoscopy.
...
FINAL DRAFT
International
Standard
ISO/FDIS 7376-2
ISO/TC 121/SC 2
Anaesthetic and respiratory
Secretariat: ANSI
equipment —
Voting begins on:
2025-05-28
Part 2:
Video laryngoscopes
Voting terminates on:
2025-07-23
Équipement anesthésique et respiratoire —
Partie 2: Vidéolaryngoscopes
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/FDIS 7376-2:2025(en) © ISO 2025
FINAL DRAFT
ISO/FDIS 7376-2:2025(en)
International
Standard
ISO/FDIS 7376-2
ISO/TC 121/SC 2
Anaesthetic and respiratory
Secretariat: ANSI
equipment —
Voting begins on:
Part 2:
Video laryngoscopes
Voting terminates on:
Équipement anesthésique et respiratoire —
Partie 2: Vidéolaryngoscopes
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2025
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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 Reference number
ISO/FDIS 7376-2:2025(en) © ISO 2025
ii
ISO/FDIS 7376-2:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 3
4.1 General .3
4.2 Risk management .3
5 Materials . 4
5.1 General .4
5.2 Exterior / External surfaces .4
6 Design requirements . 4
6.1 General .4
6.2 Components .4
6.3 Mechanical requirements .5
6.3.1 VL strength .6
6.3.2 Rigidity .6
6.3.3 Drop test .6
6.3.4 Illumination .6
6.4 Image quality .7
6.4.1 Limiting resolution .7
6.4.2 Distortion .7
6.4.3 Latency .7
6.4.4 Contrast .7
6.4.5 Image display .8
6.4.6 Field of view (FOV) .8
6.4.7 Camera lens condensation .8
6.5 Temperature .9
6.6 System communication .9
6.7 Requirements for VLs for emergency medical services .9
6.8 Transportation and storage .9
6.9 Batteries .9
7 Cleaning, disinfection and sterilization . 9
8 Information supplied by the manufacturer . 10
8.1 General .10
8.2 Marking .10
8.3 Reusable .10
8.4 Instructions for use (IFU) . .10
Annex A (informative) Rationale .12
Annex B (normative) Test method for illumination, strength and rigidity .15
Annex C (normative) Test method for determining the field of view . 17
Annex D (informative) Hazard identification for risk assessment .18
Annex E (informative) Video laryngoscope designs .20
Bibliography .22
iii
ISO/FDIS 7376-2:2025(en)
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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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 ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee
SC 2, Airway devices and related equipment.
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/FDIS 7376-2:2025(en)
Introduction
This document provides the essential performance and safety requirements for video laryngoscopes. Video
laryngoscopes are tools used to facilitate endotracheal intubation. A rigid video laryngoscope holds and
shapes the anatomical structures providing access to the trachea, not dependent on a line of sight. Video
laryngoscopes are designed to provide a view of the larynx and entrance into the trachea.
Video laryngoscopes have been developed to provide the user with a view of the larynx via a camera and an
image display unit. The use of video laryn
...
ISO/FDIS 7376-2:2025
ISO/TC 121/SC 2/WG 17
Secretariat: ANSI
Date: 2025-05-14
Anaesthetic and respiratory equipment – —
Part 2:
Video Laryngoscopeslaryngoscopes
Équipement anesthésique et respiratoire —
Partie 2: Vidéolaryngoscopes
FDIS stage
ISO/FDIS 7376-2:2025(en)
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
EmailE-mail: copyright@iso.org
Website: www.iso.orgwww.iso.org
Published in Switzerland
ii
ISO/FDIS 7376-2:2025(en)
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 3
4.1 General . 3
4.2 Risk management . 3
5 Materials . 4
5.1 General . 4
5.2 Exterior / External surfaces . 4
6 Design requirements . 4
6.1 General . 4
6.2 Components . 4
6.3 Mechanical requirements . 7
6.4 Image quality . 8
6.5 Temperature . 10
6.6 System communication . 11
6.7 Requirements for VLs for emergency medical services . 11
6.8 Transportation and storage . 11
6.9 Batteries . 11
7 Cleaning, disinfection and sterilization . 11
8 Information supplied by the manufacturer . 11
8.1 General . 11
8.2 Marking . 11
8.3 Reusable . 12
8.4 Instructions for use (IFU) . 12
Annex A (informative) Rationale . 13
Annex B (normative) Test method for illumination, strength and rigidity . 17
Annex C (normative) Test method for determining the field of view . 20
Annex D (informative) Hazard identification for risk assessment . 22
Annex E (informative) Video laryngoscope designs . 24
Bibliography . 26
iii
ISO/FDIS 7376-2:2025(en)
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 documentdocuments 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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'sISO’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 ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee
SC 2, Airway devices 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).
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/FDIS 7376-2:2025(en)
Introduction
This document provides the essential performance and safety requirements for video laryngoscopes. Video
laryngoscopes are a tooltools used to facilitate endotracheal intubation. A rigid Videovideo laryngoscope holds
and shapes the anatomical structures providing access to the trachea, not dependent on a line of sight. Video
laryngoscopes are designed to provide a view of the larynx and entrance into the trachea.
Video laryngoscopes have been developed to provide the user with a view of the larynx via a camera and an
image display unit. The use of video laryngoscopes is increasing in clinical practice and they have become an
important tool for tracheal intubation. Video laryngoscopes are particularly useful for difficult intubations and
for reducing the risk of oesophageal intubation. There areis a wide variety of video laryngoscope designs and
basic performance criteria needsneed to be established to enhance patient safety.
The video laryngoscope incorporates a light source and miniature camera to view the larynx during the
procedure of laryngoscopy. The image is displayed on a screen. Common use environments of video
laryngoscopes include: operating rooms, emergency rooms, intensive care units, and in the pre-hospital
setting. Typical users include: health care providers who intubate such as anaesthesiologists, respiratory
therapists, emergency response physicians, intensive care unit physicians, paramedics, certified nurse
anaesthetists and anaesthesia assistants.
This document is intended to provide a device specific standard focussedfocused on video laryngoscopes. Video
laryngoscopes have evolved from direct laryngoscopes but, in contrast to direct laryngoscopes providing a
direct view, video laryngoscopes provide an indirect view of the larynx made visible on an image display. Video
laryngoscopes utilize digital imaging technology and maycan require less force to visualize the larynx
compared to direct laryngoscopy.
v
ISO/FDIS 7376-2:2025(en)
Anaesthetic and respiratory equipment – —
Part 2:
Video Laryngoscopeslaryngoscopes
1 Scope
This document specifies requirements for electrically powered video laryngoscopes that comprise a handle, a
rigid blade, a light source, a camera and an image display that provides a clear view of the larynx to assist
tracheal intubation. This document specifies requirements for accessories that are essential to the function of
the video laryngoscope.
This document is not applicable to the following:
— laryngoscopes without a camera or image display (see ISO 7376));
— Endoscopesendoscopes (see ISO 8600-1));
— laryngoscopes designed for surgery;
— image quality requirement for third party display screens, for example a phone or computer monitor, and
which are not supplied by the video laryngoscope manufacturer as part of the video laryngoscope 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 7376:2020, Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 17664-1, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices.
ISO 17664-2, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 2: Non-critical medical devices.
ISO 18190:2025, Anaesthetic and respiratory equipment – — General requirements for airway devices and
related equipment
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Medical electrical equipment - − Part 1: General requirements for
basic safety and essential performance
IEC 60601-1-2, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential
performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
IEC 60601-1-6, Medical electrical equipment — − Part 1-6: General requirements for basic safety and essential
performance — − Collateral standard: Usability
ISO/FDIS 7376-2:2025(en)
IEC 60601-1-12, 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 intended for use in the emergency medical services environment
IEC 60601-2-18, Medical electrical equipment – Part 2-18: Particular requirements for the basic safety and
essential performance of endoscopic equipment
IEC 61966-12:2020-1, Multimedia systems and equipment - − Colour measurement and management - − Part
12-1: Metadata for identification of colour gamut (Gamut ID)
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
ASTM D4169, Standard Practice for Performance Testing of Shipping Containers and Systems
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4135, ISO 14971, ISO 18190:20
...
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