Nick,

This is an in process interpretation that is being currently developed by IEC 
TC62 SC 62A WG14 and was supposed to be discussed today in our London meeting 
but the submitter of the request for interpretation was not able to make the 
meeting today.  Part of the draft interpretation does mention there are fake 
chargers out there and they definitely will not meet Dielectric, spacings, and 
leakage current limits.  Also, they can reboot computers connected to the 
network, The submitter of the request says: "It has been noted in health care 
facilities recently that certain ME Equipment have rebooted, close down 
prematurely, changed alarm setting, change patient setting due to 
interconnection of other electrical equipment intended to be charged or 
powered.”

USB is not the wisest choice for power as you also have data issues potentially 
depending on the Medical device and it’s connection.  The best solution I have 
seen is 1) turn off or disable patient circuitry when connected to USB.
2) disable the software the controls the device.
3) provide additional Reinforced or Double Insulation 2 Means of Patient 
Protection (dielectric and spacings requirements)
4) Do a thorough Risk Analysis per ISO 14971:2007 (that is what IEC 
60601-1:2005 + A1:2012) or in the EU use EN 14971:2012 with the associated EN 
60601-1, ed. 3.1

Hope this helps,
        Leonard (Leo) Eisner, P.E.
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151 <tel:(503) 244-6151>
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> On Apr 11, 2018, at 8:12 AM, Mike Sherman <msherma...@comcast.net> wrote:
> 
> There are a number of documented cases of counterfeit or knock off Apple USB 
> chargers that do not pass dielectric testing; a couple have been suspected in 
> shock related deaths. This is an unstated background to this discussion.
> 
> Mike Sherman
> Graco Inc.
> 
> From: "Ari Honkala" <ari.honk...@sesko.fi>
> To: "EMC-PSTC" <EMC-PSTC@LISTSERV.IEEE.ORG>
> Sent: Wednesday, April 11, 2018 5:20:35 AM
> Subject: Re: [PSES] Medical device risk assessment - faulty chargers
> 
> My first thought: what has the origin of the charger has to do with it being 
> potentially faulty? Any device may broke; that's why there are requirements 
> for single fault condition.
> 
> with best regards,
> 
> Ari Honkala
> 
> -----Original Message-----
> From: Nick Williams [mailto:nick_willi...@conformance.co.uk] 
> Sent: tiistai 10. huhtikuuta 2018 19:21
> To: EMC-PSTC@LISTSERV.IEEE.ORG
> Subject: [PSES] Medical device risk assessment - faulty chargers
> 
> 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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