ISO 7376-2020 pdf free.Anaesthetic and respiratory equipment- Laryngoscopes fortracheal intubation.
1.This document, which is device-specific, specifies requirements for laryngoscopes with non-flexibleblades，with internal battery-operated power sources,used for illuminating the larynx duringintubation. It also specifies critical dimensions for those handles and laryngoscope blades withinterchangeable hook-on fittings.lt 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 contentconstitutes requirements of this document. For dated references, only the edition cited applies. Forundated references, the latest edition of the referenced document (including any amendments) applies.ISO 4135,Anaesthetic and respiratory equipment — Vocabulary
ISO 18190:2016,Anaesthetic and respiratory equipment —General requirements for airways and relatedequipment
IEC 60601-1-12:2014,Medical electrical equipment — Part 1-12: General requirements for basic safety andessential performance —Collateral Standard: Requirements for medical electrical equipment and medicalelectrical systems used in the emergency medical services environment.
Handles with a rated voltage exceeding 3,8 V and designed for use with hook-on fitting, directlyilluminating laryngoscope blades, shall incorporate a means of preventing the electrical current fromexceeding 800 mW peak(measured over a period of 100 ms) and from exceeding 400 mW continuousduring normal use and single fault conditions.NOTE1 For a handle rated at 6 V, these are equivalent to current limits of 133 mA and 67 mA respectively.NOTE2 The return electrical circuit is through unspecified parts of the hook on fitting.Check conformance by inspection of the technical file.
Electrical contact:The electrical contact of a handle that can accept a hook-on fitting, directly illuminating laryngoscopeblade shall be either flexible or spring-loaded.Check conformance by functional testing.
Handles for use with hook-on fitting, directly illuminating laryngoscope blades and hook-on fitting, light-guide illuminated laryngoscope blades shall conform to the dimensions given in Figure 1, and Table 1.Check conformance by functional testing.ISO 7376 pdf download.