SIST EN ISO 7376:2020/A1:2025
(Amendment)Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation - Amendment 1: Clarification of optical output and illumination requirements (ISO 7376:2020/Amd 1:2025)
Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation - Amendment 1: Clarification of optical output and illumination requirements (ISO 7376:2020/Amd 1:2025)
Anästhesie- und Beatmungsgeräte - Laryngoskope für Trachealintubation - Änderung 1 (ISO 7376:2020/Amd 1:2025)
Matériel d'anesthésie et de réanimation respiratoire - Laryngoscopes pour intubation trachéale - Amendement 1: Clarification concernant la puissance optique et les exigences relatives à l’éclairage (ISO 7376:2020/Amd 1:2025)
Anestezijska in dihalna oprema - Laringoskopi za trahealno intubacijo - Dopolnilo A1: Pojasnilo zahtev optičnih izhodov in osvetlitev (ISO 7376:2020/Amd 1:2025)
General Information
Relations
Overview
EN ISO 7376:2020/A1:2025 is a CEN-endorsed amendment to ISO 7376:2020 that clarifies optical output and illumination requirements for laryngoscopes used in tracheal intubation. Approved by CEN (15 December 2024) and published in 2025, this amendment provides measurable criteria for light output from handles and for the illuminated field produced by light-guide blades, improving interoperability and testability of laryngoscope systems.
Key topics and requirements
- Handle optical output: Handles designed for hook-on, light-guide illuminated blades shall deliver > 3 lumen optical output.
- This requirement applies to handles intended to be interchangeable with multiple blades.
- Conformance is verified using the test method in Annex B.
- System illumination supersedes handle-only rule: If a manufacturer supplies a complete laryngoscope system (handle + light-guide blade), the system illumination criteria take precedence.
- Illumination geometry and intensity (clauses 7.2.4 a–d):
- Horizontal (left–right) illumination span: > 50 mm and < 100 mm
- Vertical (upper–lower) illumination span: > 30 mm and < 80 mm
- Distance from blade tip to lower illumination edge: < 3 mm
- Illuminance: > 500 lux sustained for > 10 minutes
- Design guidance (Annex A): A handle output of 3 lumen is specified as a minimum to guide manufacturers, but the amendment notes that blade transmission losses vary; 500 lux cannot be guaranteed for all handle/blade combinations and the standard does not specify minimum blade transmission efficiency.
- Minor editorial updates: e.g., Figure B.1 table header labeled “Requirement” and B.3 f) updated to > 3 lumen.
Applications
- Product design and engineering: specify minimum light output and illumination geometry for laryngoscope handles and blades.
- Testing and conformity assessment: use Annex B test method to verify handle and system performance.
- Procurement and clinical specification: include measurable illumination metrics (> 500 lux, span dimensions, lumen) in tender documents.
- Quality assurance and maintenance: ensure devices meet sustained illuminance and spatial coverage for safe tracheal intubation.
Who should use this standard
- Medical device manufacturers (handles, light-guide blades, complete laryngoscopes)
- Biomedical engineers and clinical engineers
- Test laboratories and conformity assessors
- Hospital procurement teams and clinical departments (anesthesia, emergency medicine)
- Regulatory and standards bodies implementing EN/ISO requirements
Related standards
- ISO 7376:2020 (base standard for laryngoscopes) - this document is Amendment 1: 2025 and is endorsed as EN ISO 7376:2020/A1:2025 by CEN.
Keywords: EN ISO 7376:2020/A1:2025, laryngoscopes, tracheal intubation, optical output, illumination, 3 lumen, 500 lux, light-guide blade, Annex B test.
Frequently Asked Questions
SIST EN ISO 7376:2020/A1:2025 is a amendment published by the Slovenian Institute for Standardization (SIST). Its full title is "Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation - Amendment 1: Clarification of optical output and illumination requirements (ISO 7376:2020/Amd 1:2025)". This standard covers: Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation - Amendment 1: Clarification of optical output and illumination requirements (ISO 7376:2020/Amd 1:2025)
Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation - Amendment 1: Clarification of optical output and illumination requirements (ISO 7376:2020/Amd 1:2025)
SIST EN ISO 7376:2020/A1:2025 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 7376:2020/A1:2025 has the following relationships with other standards: It is inter standard links to SIST EN ISO 7376:2020. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
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Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2025
Anestezijska in dihalna oprema - Laringoskopi za trahealno intubacijo - Dopolnilo
A1: Pojasnilo zahtev optičnih izhodov in osvetlitev (ISO 7376:2020/Amd 1:2025)
Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation -
Amendment 1: Clarification of optical output and illumination requirements (ISO
7376:2020/Amd 1:2025)
Anästhesie- und Beatmungsgeräte - Laryngoskope für Trachealintubation - Änderung 1
(ISO 7376:2020/Amd 1:2025)
Matériel d'anesthésie et de réanimation respiratoire - Laryngoscopes pour intubation
trachéale - Amendement 1: Clarification concernant la puissance optique et les
exigences relatives à l’éclairage (ISO 7376:2020/Amd 1:2025)
Ta slovenski standard je istoveten z: EN ISO 7376:2020/A1:2025
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 7376:2020/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2025
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Anaesthetic and respiratory equipment - Laryngoscopes
for tracheal intubation - Amendment 1: Clarification of
optical output and illumination requirements (ISO
7376:2020/Amd 1:2025)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Laryngoskope für
Laryngoscopes pour intubation trachéale - Trachealintubation - Änderung 1 (ISO 7376:2020/Amd
Amendement 1: Clarification concernant la puissance 1:2025)
optique et les exigences relatives à l'éclairage (ISO
7376:2020/Amd 1:2025)
This amendment A1 modifies the European Standard EN ISO 7376:2020; it was approved by CEN on 15 December 2024.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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, Türkiye 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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7376:2020/A1:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 7376:2020/A1:2025) 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 Amendment to the European Standard EN ISO 7376:2020 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by December 2025,
and conflicting national standards shall be withdrawn at the latest by December 2025.
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.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 7376:2020/Amd 1:2025 has been approved by CEN as EN ISO 7376:2020/A1:2025
without any modification.
International
Standard
ISO 7376
Third edition
Anaesthetic and respiratory
2020-08
equipment — Laryngoscopes for
tracheal intubation
AMENDMENT 1
2025-06
AMENDMENT 1: Clarification of
optical output and illumination
requirements
Reference number
ISO 7376:2020/Amd.1:2025(en) © ISO 2025
ISO 7376:2020/Amd.1:2025(en)
© ISO 2025
All rights
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