What is ISO 7376 about?
ISO 7376 discusses Laryngoscopes for tracheal intubation for anaesthetic and respiratory equipment. ISO 7376 outlines requirements for laryngoscopes with non-flexible blades, with internal battery-operated power sources, used for illuminating the larynx during intubation.
ISO 7376 also specifies critical dimensions for those handles and laryngoscope blades with interchangeable hook‐on fittings.
Note: ISO 7376 does not apply to flexible laryngoscopes, laryngoscopes designed for surgery, laryngoscopes powered from the 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.
Who is ISO 7376 for?
ISO 7376 on anaesthetic and respiratory equipment is useful for:
- Manufacturers of anaesthetic and respiratory equipment
- Test centres for anaesthetic and respiratory equipment
- Regulatory authorities
Why should you use ISO 7376?
Laryngoscopes are manufactured in several forms. There are, for example, single‐piece laryngoscopes, non‐user-detachable hinged laryngoscope blades, or detachable hinged laryngoscope blades and handles.
ISO 7376 guideline provides requirements, material, design requirements, cleaning, disinfection, labelling, marking, packaging, and sterilization for Laryngoscopes for tracheal intubation. ISO 7376 also provides performance requirements on electrical safety, dimensions, optical output, and electrical interface for anaesthetic and respiratory equipment. This improves the quality and ensures the safety of patients and operators.
What’s changed since the last update?
BS EN ISO 7376:2020 supersedes ISO 7376:2009, which has been withdrawn. BS EN ISO 7376:2020 has some technical changes with respect to ISO 7376:2009. These include:
- The layout has changed to align with ISO 18190:2016
- Removal of the requirements for filament luminaires, which are now almost entirely replaced by LED luminaires
- Additional requirement to prevent current surges from batteries with a rated voltage exceeding 3,6 V, and test methods have been rationalized
- Each requirement is now followed by a conformance requirement and the strength requirement has been extended to handles
- Environmental conditions during transport, storage and normal use are now referenced to IEC 60601-1-12.