ISO 7376-2:2025

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

• Status: Published
• Publication Date: 01-Sep-2025
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: ISO/TC 121/SC 2 - Airways and related equipment
• Drafting Committee: ISO/TC 121/SC 2 - Airways and related equipment
• Current Stage: 6060 - International Standard published
• Start Date: 02-Sep-2025
• Due Date: 06-Jun-2026
• Completion Date: 02-Sep-2025

Overview

ISO 7376-2:2025 - Anaesthetic and respiratory equipment - Part 2: Video laryngoscopes defines safety and performance requirements for electrically powered video laryngoscopes. The standard applies to systems that include a handle, a rigid blade, an integrated light source, a camera and an image display that together provide a clear view of the larynx to assist tracheal intubation. It covers essential accessories and device lifecycle considerations (cleaning, storage, batteries, instructions). It explicitly excludes laryngoscopes without a camera (see ISO 7376), endoscopes (ISO 8600‑1), surgical laryngoscopes and image quality requirements for third‑party displays not supplied as part of the system.

Key Topics and Technical Requirements

ISO 7376-2:2025 focuses on device-specific performance, testing and information requirements, including:

• General requirements & risk management aligned with ISO 14971.
• Materials and external surface considerations for patient safety and cleaning.
• Design requirements covering components, mechanical performance and durability:
  • Strength, rigidity and drop testing.
  • Illumination performance and prevention of camera lens condensation.
• Image quality specifications and testable parameters:
  • Limiting resolution, distortion, latency, contrast.
  • Image display performance and field of view (FOV) requirements.
• System communication, temperature, batteries, transportation and storage constraints.
• Cleaning, disinfection and sterilization instructions and manufacturer-supplied processing information (ISO 17664 references).
• Information for users: markings, labelling and Instructions for Use (IFU).
• Normative and informative annexes providing test methods (illumination, FOV), hazard identification and example designs.

Practical Applications and Users

ISO 7376-2:2025 is useful for:

• Manufacturers and product designers developing electrically powered video laryngoscopes to meet recognized performance and safety criteria.
• Regulatory and quality teams preparing technical files, conformity assessments and clinical evaluation for market approval.
• Test laboratories and compliance engineers executing specified mechanical and image-quality tests (annex test methods).
• Hospital procurement, clinical educators and airway management teams (anaesthesiologists, intensivists, emergency physicians, paramedics, respiratory therapists) seeking devices that conform to standardized performance and safety expectations.

Adoption of the standard promotes improved patient safety (especially for difficult intubations), consistent device performance and clear manufacturer guidance on cleaning and use.

Related Standards

Key related documents referenced by ISO 7376-2:2025:

• ISO 7376:2020 (laryngoscopes without camera)
• ISO 14971 (risk management)
• IEC 60601 series (medical electrical equipment)
• IEC 60601-2-18 (endoscopic equipment)
• ISO 18190 (general requirements for airway devices)
• ISO 17664 (processing/IFU requirements)

Keywords: ISO 7376-2:2025, video laryngoscopes, anaesthetic and respiratory equipment, image quality, field of view, medical device standard, risk management.

Standards Content (Sample)

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: [phone]
Email: [e-mail]
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)
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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.

v
International Standard ISO 7376-2:2025(en)
Anaesthetic and respiratory equipment —
Part 2:
Video laryngoscopes
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);
— 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.
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

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 61966-12-1, 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,
IEC 60601-2-18 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
blade
part of the video laryngoscope (3.11) inserted into the patient to facilitate a view of the larynx on an image
display (3.8)
3.2
contrast
relationship or degree of tonal gradation between the lightest and darkest areas in an original or
reproduction
[SOURCE: ISO 12637-2:2008, 2.38]
3.3
distortion
deviation between the actual location of an image point and the location that theoretically would result
from the geometry of the imaging process without any errors
[SOURCE: ISO 19130-1:2018, 3.50, modified — The preferred term “image distortion ” was changed to
“distortion”.]
3.4
field of view
FOV
width and height of an imaged region
Note 1 to entry: Expressed in degrees.
[SOURCE: ISO/TR 16379:2014, 2.4, modified — Information on the unit was moved to a note to entry; “cm or
mm” was replaced with “degrees”.]
3.5
glare
optical artefact, overpowered bright patch of ambient light or diffused specular reflection on a surface, that
obscures the original image content

3.6
handle
part of the video laryngoscope (3.11) which is held by the user during laryngoscopy
3.7
hyperangulated blade
blade (3.1) designed with an acute radius of curvature to provide an indirect view of the larynx on a display
3.8
image display
screen displaying digital images captured by a camera
3.9
intended use
use for which a video laryngoscope (3.11) is intended according to the specifications, instructions and
information provided by the manufacturer
[SOURCE: IEC 60601-1:2005+AMD1:2012+AMD2:2020, 3.44, modified — The preferred term “intended
purpose” has been removed; “product, process or service ” has been changed to “video laryngoscope”.]
3.10
lens flare
optical artefact, often colourful geometric shapes, caused by reflections between lens layers inside a camera
3.11
video laryngoscope
VL
device used to perform a laryngoscopy and that provides visualisation of airway structures through use of a
video system to facilitate tracheal intubation
Note 1 to entry: Some designs of VL can also be used as direct laryngoscopes (see Clause A.4).
4 General requirements
4.1 General
The requirements of ISO 18190:2025, Clause 4 shall apply.
NOTE Refer to Annex D for hazard identification for risk assessment.
The manufacturer may use type tests different from those detailed within this document if an equivalent
degree of safety is obtained. Alternative test methods shall be validated against the test methods specified
in this document.
4.2 Risk management
4.2.1 Risk assessment shall address the risk posed by an operator viewing a recorded image rather than a
live image during the laryngoscope procedure.
Check conformance by inspection of the risk management file.
4.2.2 The possibility of the live image during a laryngoscopy procedure being obstructed by icons or
controls shall be addressed in the risk management process.
Check conformance by inspection of the risk management file.
4.2.3 The requirements of cybersecurity shall be considered, if applicable.
Check conformance by inspection of the risk management file.

5 Materials
5.1 General
The applicable requirements of ISO 18190:2025, Clause 5 shall apply.
5.2 Exterior / External surfaces
5.2.1 VLs shall be designed in such a way that their intended use will not lead to any unintentional injuries.
Check conformance by inspection of the risk management file.
5.2.2 Rough surfaces, sharp corners and edges of the VL that could cause injury, or damage shall be avoided
or covered. In particular, attention shall be paid to flange or frame edges.
Check conformance by visual inspection.
6 Design requirements
6.1 General
The requirement of ISO 18190:2025, Clause 6 shall apply.
6.2 Components
A VL may consist of the components shown in Figure 1 and Figure 2. An example of a single use VL is depicted
in Figure 3.
Key
1 image display, integrated (or interchangeable)
2 power source, integral (or interchangeable)
3 camera and illumination housing (rigid) including a light source
4 handle
5 blade
Figure 1 — Example of VL with blade and integrated image display

Key
1 handle
2 handle cover with integrated blade
3 camera and illumination housing (flexible)
4 blade
5 cable, connecting handle to image display
6 image display
Figure 2 — Example of VL, with handle cover with integrated blade and non-integrated monitor
Key
1 handle
2 blade
3 image display
Figure 3 — Example of single use VL
6.3 Mechanical requirements
NOTE There is rationale for this subclause in Clause A.3.
6.3.1 VL strength
6.3.1.1 No parts of a VL indicated for use in adults shall break or separate when subjected to an applied
force of 150 N.
NOTE There is rationale for this subclause in Clause A.1.
Check conformance by the test method given in Annex B.
6.3.1.2 No parts of a video laryngoscope indicated for use in paediatric or neonatal patients shall break
or separate when subjected to an applied force specified by the manufacturer. The manufacturer shall
determine the applied forces in their risk management process.
NOTE There is rationale for this subclause in Clause A.1.
Check conformance by inspection of the risk management file and the test method given in Annex B at the
applied force specified by the manufacturer.
6.3.1.3 If user-detachable, the blades and handles of a video laryngoscope shall not disconnect when
subjected to an applied load of 60 N.
Check conformance by functional testing.
6.3.2 Rigidity
6.3.2.1 With the blade fitted to handle: when subjected to an applied force of 65 N, the image shall remain
visible and appropriate for intubation.
Check conformance by application of usability process specified in IEC 60601-1-6 or IEC 62366-1.
6.3.2.2 When a VL consists of interchangeable or detachable components, the force required for
engagement shall not exceed 45 N.
Check conformance by functional testing.
6.3.3 Drop test
VLs shall be tested using the drop test requirements in IEC 60601-1:2005+AMD1:2012+AMD2:2020,
Clause 15.3.4 and shall not result in an unacceptable risk.
Check conformance by inspection of the risk management file.
NOTE There is rationale for this subclause in Clause A.2.
6.3.4 Illumination
6.3.4.1 VL intended for use for direct laryngoscopy shall comply with the illumination requirements of
ISO 7376.
NOTE There is rationale for this subclause in Clause A.3.
Check conformance by the test method given in ISO 7376:2020, Annex B.
6.3.4.2 VL solely intended for video assisted laryngoscopy can have a lower illumination than that
specified in ISO 7376.
Check conformance by application of the usability process specified in IEC 60601-1-6 or IEC 62366-1.
6.3.4.3 VL indicated for neonatal and paediatric use shall have an optical output > 150 lux when measured
(25 ± 1) mm from the tip of the blade.
Check conformance by test method in Annex B.

6.3.4.4 Maximum illuminance difference between centre and any edge of the image visible on image
display shall be < 40 %.
Check conformance by test method in Annex B.
6.4 Image quality
NOTE There is rationale for this subclause in Clause A.4.
6.4.1 Limiting resolution
The maximum number of line pairs per picture height which can be resolved at a given working distance
shall be determined and disclosed in the instructions for use (IFU).
Check conformance by visual inspection of a line pair chart conforming to ISO 12233 and the IFU.
6.4.2 Distortion
The geometric distortion of the image on the image display shall be: −20 % < distortion < 20 %. The actual
distortion value shall be disclosed in the IFU.
Distortion can be calculated by:
% Distortion = (D – D ) / D × 100 %
A P P
where:
D is the actual distance
A
D is the paraxial, or predicted distance
P
Alternatively, an image of a checkerboard pattern may be analysed with image analysis software.
Check conformance by functional testing and inspection of the IFU.
6.4.3 Latency
The latency of the live image on image display shall be < 200 ms.
NOTE The latency can be checked by viewing a timer with a minimum resolution 10 ms through the VL and then
capturing an image of both the timer and the timer displayed on the VL’s image display. The latency is the difference in
time observed on the timer and ti
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