There is obviously no unique answer. You can:
- not use USB and provide a charger with a unique connector (my choice);
- use USB, but put full overvoltage and overcurrent protection in your
product;
- rely on warning notices (not recommended!)
John Woodgate OOO-Own Opinions Only
J M Woodgate and Associates www.woodjohn.uk
Rayleigh, Essex UK
On 2018-04-10 17:21, Nick Williams wrote:
Colleagues,
EN 60601-1 3rd ed. requires the manufacturer to take a risk assessment based
approach to the safety of their electrical medical products.
With the increased used of universal USB power as a source for battery
charging, it’s easy for the risk assessment to identify use of the medical
device with a potentially faulty charger either because the device manufacturer
has not included a USB power adapter/charger wth the product or because the
user has chosen to use a charger other than the one supplied by the
manufacturer.
How far does the manufacturer need to go in order to provide protection against
the hazards from a faulty charger, not supplied by them? Bear in mind the
hazardous scenarios may include a patient contact device being used while being
charged.
I await opinions with interest!
NIck.
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