Customer has a medical wall-wort power supply that has the typical NRTL (call them NRTL1) safety mark that you'd expect to see on a power supply marketed within the USA. Customer's entire device is located within the secondary of that wall-wort power supply and includes no connections to other mains connected devices.
Now another one of the large well-known NRTLs (I'll call them NRTL2) which is handling the AAMI 60601-1 project for customer's end product is requiring that 100% dielectric voltage withstand testing be repeated on the power supplies. The power supply manufacturer has provided sections of their NRTL1 File that details the requirement for 100% testing of their supply in manufacturing as well as the voltage amplitude and duration required. Still, customer's NRTL2 is demanding that this test be repeated upon 100% of the power supplies at customer's premises. It appears that I have no choice but to agree to repeat the additional testing. This adds cost to manufacturing and flies in the face of great efforts on the part of American manufacturers that try to keep their operations within the USA by maximizing productivity. I've worked on many other projects with wall-wort and external brick power supplies with other NRTLs and this has never been a requirement. I try to keep an open mind even when I'm disagreed with. But I think that this is the first time in my 30ish years of compliance work that I've seen engineering judgment completely thrown out the window. I'm interested in other points of view. Carl - ---------------------------------------------------------------- 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 <[email protected]> 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://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]>
