ISO 7376-2020 pdf download.Anaesthetic and respiratory equipment一Laryngoscopes for tracheal intubation.
This document, which is device-specific, specifies requirements for laryngoscopes with non-flexibi blades, with internal battery-operated power sources, used for illuminating the larynx dunn intubation. It also specifies critical dimensions for those handles and laryngoscope blades wit 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 conter constitutes requirements of this document. For dated references, only the edition cited applies. Fc undated references, the latest edition of the referenced document (including any amendments) applie
ISO 4135, Anaesthetic and respiratory equipment — Vocabulary
ISO 18190:2016, Anaesthetic and respiratory equipment — General requirements for airways and relate equipment
IEC 60601-1-12:2014, Medical electrical equipment — Part 1-12: General requirements for basic safety an essential performance — Collateral Standard: Requirements for medical electrical equipment and medic electrical systems used in the emergency medical services environment
3 and definitions
For the purposes of this document, the terms and definitions given in ISO 4135, ISO 18190 and th following apply:
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www,isu.org/obp
— IEC Electropedia: available at http://www.elearopediLorg/
3.1 contact
metallic part that provides the electrical connection between a hinged laryngoscope blade an handle (14)
3.2 directly illuminating Ia ryngoscope blade
3.3 engagement
mechanical attachment of the laryngoscope blade and handle (3.4) such that the blade remains coupled
to the handle in all positions
3.4 handle
component held in the hand during use
3.5 hook-on fitting
mechanical connection between a handle (3.4) and a user-detachable laryngoscope blade
3.6 light-guide illuminated laryngoscope blade
laryngoscope blade that transmits light from a source in the handle (3.4)
3.7 locking mechanism
mechanism that retains the laryngoscope blade in the operating position
3.8 luminaire
light source
3.9 non-user-detachable hinged laryngoscope blade
folding laryngoscope blade that cannot be separated from a handle (3.4) by the operator
3.10 single-piece laryngoscope
handle (3.4) with a fixed laryngoscope blade
4 General requirements
The applicable requirements of ISO 18190:2016, Clause 4 shall apply.
5 Materials
The applicable requirements of ISO 18190:2016, Clause 5 shall apply.
6 Design requirements
6.1 General
The aplicable requirements of ISO 18190:2016, Clause 6 shall apply.ISO 7376 pdf download.
Tags: Anaesthetic and respiratory equipment
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