I am choosing wires for our medical ventilator design, and am very confused. Since our device would have to be classified as a Class II medical electrical equipment, I figure that the wires used in the ventilator need to satisfy certain certifications. However, the only info about the electrical requirements for Class II equipments is listed below: (https://www.ebme.co.uk/articles/electrical-safety/classes-and-types-of-medical-electrical-equipment#:~:text=Class%20II%20medical%20electrical%20equipment,double%20insulation%20as%20shown%20below.):
The method of protection against electric shock in the case of class II equipment is either double insulation or reinforced insulation. In double insulated equipment the basic protection is afforded by the first layer of insulation. If the basic protection fails then supplementary protection is provided by a second layer of insulation preventing contact with live parts.
In practice, the basic insulation may be afforded by physical separation of live conductors from the equipment enclosure, so that the basic insulation material is air. The enclosure material then forms the supplementary insulation.
Reinforced insulation is defined in standards as being a single layer of insulation offering the same degree of protection against electric shock as double insulation.
Can anyone familiar with the medical device industry suggest how I can find qualified wires/cables on digikey?
Thanks so much ><