Roger, It appears from your email that you are the manufacturer of the adaptor. I am assuming this to be the case. Firstly, the adaptor should have been designed for compliance with and tested to the appropriate sections of IEC 60601-1 and IEC 60601-1-2. Strictly speaking, the adapter does not need to bear the CE Mark, nor do you need a DoC, if it is only sold to OEM's. It is a component of a medical device, and as such, is not a medical device or an accessory of a medical device and so is not within the scope of the Medical Devices Directive. It must, of course, allow the final product comply with the requirements of the MDD. Of course, you can CE Mark it to the LVD and EMC Directive and declare to IEC 60601-1 and IEC 60601-1-2, as long as you keep in the Technical File an engineering justification for these standards providing compliance with the essential requirements of these Directives. This should be acceptable, as it is generally recognised that these standards are more stringent than standards in the Harmonised Standards lists for these Directives. Regards, Jon Griver http://www.601help.com The Medical Device Designer's Guide to IEC 60601-1 ----- Original Message ----- From: [email protected] To: IEEE <mailto:[email protected]> EMC Discussion Group Sent: Monday, August 07, 2006 6:43 AM Subject: CE mark Adaptor for Medical equipment
Hi, An adaptor (stand-alone power supply unit) is required to CE mark to the Low Voltage Directive and the EMC Directive, is it appropriate to use EN60601-1 and EN60601-1-2 standard in the DoC? The end application of the adaptor is with medical equipment. The reason I am asking is because these two standards are only found in OJ Harmonised standards list for the Medical Device Directive, but not in the LVD or EMC Directive. Thanks, Roger - ---------------------------------------------------------------- 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 _____ No virus found in this incoming message. Checked by AVG Free Edition. Version: 7.1.394 / Virus Database: 268.10.7/410 - Release Date: 05/08/2006 ______________________________________________________________________ This email has been scanned by the MessageLabs Email Security System. For more information please visit http://www.messagelabs.com/email ______________________________________________________________________ - ---------------------------------------------------------------- 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
