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. ----- Original Message ----- 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. - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <emc-p...@ieee.org> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <sdoug...@ieee.org> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher: <j.bac...@ieee.org> David Heald: <dhe...@gmail.com> - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <emc-p...@ieee.org> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <sdoug...@ieee.org> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher: <j.bac...@ieee.org> David Heald: <dhe...@gmail.com> - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <emc-p...@ieee.org> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <sdoug...@ieee.org> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher: <j.bac...@ieee.org> David Heald: <dhe...@gmail.com>
