The end product is an ITE (DVB) and in the previous models, we have made use of an open frame AC/DC power supply unit. This PSU had CB certificate according to IEC60950-1. Then we went to a third party body for testing the complete unit according to IEC60950-1. Since we had a CB certificate, the scope of work for testing the ITE was limited a lot, since no testing / examination on the PSU itself was necessary.
Now, we want to change PSU to another open frame AC/DC power supply unit. This PSU has a CB cert acc to IEC 60601-1, while the end product still shall conform according to IEC60950-1. Since the new PSU shall be placed inside the ITE, some safety test and evaluations must be done. But we would also assume that a 601-1 PSU should be more "safe" than an 950-1 PSU, seen from an application point of view. We accept that some safety testing must be done on the end product. But we find it a bit strange if the introduction of this medical PSU involves more testing than if we had made use of a 950-1 PSU. #Amund -----Opprinnelig melding----- Fra: Brian O'Connell [mailto:[email protected]] Sendt: 14. september 2010 18:56 Til: [email protected] Emne: Re: [PSES] IEC 60950-1 vs IEC 60601-1 WARNING - Fractious dichotomous isochroous nondeterministic reply follows. I am not certain of Mr. Westin's use of "PSU". IEC60950-1 has no definition for the phrase 'power supply unit', and contextual meaning is not consistent. IEC60601-1 uses the phrase 'power supply unit' only when referring to a separate external power source. For a COMPONENT power supply, where the final determination is the end-use installation - the 'PSU' CB report can use a TRF based on almost any product safety standard that would scope a 'PSU'. For a power supply that has been assessed as an end-product, neither standard provides complete coverage for the requirements of the other for many uses, and for some uses either standard could provide coverage for a superset of the requirements. Anyone wanna see a De Morgan reduction of that logic ? The coming (????) of the UL/EN/IEC62368-1 standard may provide an unintended formal method to 'bridge' various requirements for component power supplies. Most I.T. CB reports for component power supplies require the repeat of some Type Tests in the end-use installation. So for a medical 'PSU', the pudding would not get cooked until it was subject to tests in your I.T. box. Conversely, the 3d edition of 60601-1 specifically addresses the use of I.T. component power supplies for some medical equipment. The CB report could be considered valid; or not. Additional tests could be required; or not. Non-related Note: the '#' at the signature threw some interesting errors for my auto-mail program - thanks for the programmatic work-out. Brian > -----Original Message----- > From: [email protected] [mailto:[email protected]]On Behalf Of Amund > Westin > Sent: Tuesday, September 14, 2010 1:05 AM > To: [email protected] > Subject: IEC 60950-1 vs IEC 60601-1 > > Is it possible to make use of a CB certificated (IEC > 60601-1) PSU, into a > ITE which shall be approved according to IEC60950-1? > > Well, I assume that's OK, but should we expect additional > tests on the PSU / > ITE since it's not CB acc to IEC60950-1? > > Thanks. > #Amund - ---------------------------------------------------------------- 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.ieeecommunities.org/emc-pstc Graphics (in well-used formats), large files, etc. can be posted to that URL. 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]> - ---------------------------------------------------------------- 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.ieeecommunities.org/emc-pstc Graphics (in well-used formats), large files, etc. can be posted to that URL. 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]>
