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.
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