ISO 7376-2020 pdf free download.Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation.
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 applicable requirements of ISO 18190:2016, Clause 6 shall apply.
6.2 *Environmental conditions
Laryngoscopes shall remain operational when subjected to the environmental conditions specified in IEC 60601-1-12:2014, 4.1.
7 Performance requirements
7.1 Handles
7.1.1 *Electrical safety
Handles with a rated voltage exceeding 3,8 V and designed for use with hook‐on fitting, directly illuminating laryngoscope blades, shall incorporate a means of preventing the electrical current from exceeding 800 mW peak (measured over a period of 100 ms) and from exceeding 400 mW continuous
during normal use and single fault conditions.
NOTE 1 For a handle rated at 6 V, these are equivalent to current limits of 133 mA and 67 mA respectively.
NOTE 2 The return electrical circuit is through unspecified parts of the hook‐on fitting. Check conformance by inspection of the technical file.
7.1.2 Electrical contact
The electrical contact of a handle that can accept a hook‐on fitting, directly illuminating laryngoscope blade shall be either flexible or spring-loaded.
Check conformance by functional testing.
7.1.3 Dimensions
Handles for use with hook‐on fitting, directly illuminating laryngoscope blades and hook‐on fitting, lightguide illuminated laryngoscope blades shall conform to the dimensions given in Figure 1, and Table 1.
Check conformance by functional testing.ISO 7376 pdf download.