It should be acceptable for a Declaration of Conformity to the LVD to reference a 60601-1 test certificate, if the test reports indicate that performance and construction conforms to the requirements of something like 60950-1.
luck, Brian From: [email protected] [mailto:[email protected]]On Behalf Of Jon Griver Sent: Thursday, February 15, 2007 12:57 AM To: [email protected] Cc: Paolo Peruzzi Subject: Re: veterinary equipment Paolo, Veterinary applications are not covered by the MDD. Clause 2(a) of Article 1 specifically refers to 'human beings'. So the Low Voltage Directive and EMC Directive are the relevant Directives for electrical veterinary equipment. However, EN 60601-1 does include veterinary equipment in its scope, where a patient is defined as a 'person or animal'. Therefore it is possible that this would be the most appropriate safety standard, and in this case the Low Voltage Directive Declaration of Conformity should refer to EN 60601-1, even though this is not in the Harmonised Standards List for the LVD. Regards, Jon Griver http://www.601help.com The Medical Device Designer's Guide to IEC 60601-1 On 15/02/07, Paolo Peruzzi <[email protected]> wrote: Dear all, under which EU directive(s) should fall a device suited for veterinary applications? Can it be deemed a medical device? Regards, Paolo Peruzzi - 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 ______________________________________________________________________ This email has been scanned by the MessageLabs Email Security System. For more information please visit http://www.messagelabs.com/email ______________________________________________________________________
