Dear all, I was hoping you could give me some guidance as to the European requirements for an Appliance Inlet in medical devices.
I spoke to a person working at a test house and he said you have to find an appliance inlet that has UL, CSA, and VDE or TUV approval. He told me that there is a standard (IEC 60309), which specifies the requirements a manufacturer must meet to produce appliance inlets. According to him, we have to purchase an appliance inlet that meets IEC 60309. I have looked through EN60601-1 and have found nothing that says the appliance inlet must be VDE or TUV approved for use in Europe. An appliance inlets that have UL/CSA markings, would be accepted in Europe? Any information you might have regarding this issue would be greatly appreciated. Thank you, Paolo Peruzzi Regulatory Medical R&D El.En. S.p.A. Via Baldanzese, 17 50041 Calenzano (FI) Italy Tel. +39 055 8826807 FAX +39 055 8832884 http://www.elengroup.com/ - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to [email protected] 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] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
