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It's an Applied Part if it could make contact with the patient during normal use of the device (whether or not such contact is needed for the device to fulfil its intended function). Impedance to earth is not a consideration in determining whether it's an Applied Part or not. You could only consider it as Enclosure if it won't make patient contact during use. Many articulated-arm medical laser systems commonly will make such contact - whether your system could you will need to judge from its intended application. If on this basis your arm is an Applied Part, then it can't be Type BF or CF if it has low impedance to earth - it would have to be Type-B. Although the generic standard EN-60601-1 allows use of Type-B Applied Parts, some of the Particular Standards for medical devices do not (typically depending upon the nature of the device and its intended use). Ged Dean From: standards [mailto:[email protected]] Sent: 14 July 2004 16:27 To: [email protected] Subject: medical laser equipment applied parts http://www.ieee-pses.org/symposium http://www.emc2004.org/ Dear all, Let's consider a medical laser device with delivers its output (laser beam) through an articulated mechanical arm; the arm is metallic and connected to the chassis. The arm has no electrical connections to the rest of the equipment. I'm in trouble with leakage currents and applied voltage testing. My question is: according to EN 60601-1, if the impedance from the arm to earth is less than 100 mohms, can I think of it simply as an extension of the chassis, instead of an applied part? And if the impedance is more than 100 mohms? thanks, Paolo Paolo Peruzzi Regulatory Engineer 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. IEEE PSES Main Website: http://www.ieee-pses.org/ To post a message send your e-mail to [email protected] Instructions for use of the list server: http://listserv.ieee.org/listserv/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. IEEE PSES Main Website: http://www.ieee-pses.org/ To post a message send your e-mail to [email protected] Instructions for use of the list server: http://listserv.ieee.org/listserv/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
