Dick, To the best of my knowledge there is no EN standard or guidance on production tests for medical equipment (There is a standard, EN 50116, for IT equipment). Your best bet is to discuss this with your Notified Body and to come to a mutually acceptable set of tests.
Regards, Jon Griver Medson Ltd. > Good Day Everyone > Question I have - Does anyone out there know if an EN standard or guidance > document exists that deals with production line test requirements of > finished medical devices. > Reading in EN60601-1 it states that the test (ground resistance, high > potential, etc.) are type test only (See appendix B, and then paragraph > 4.1). Thus - they are not identified as production line tests. I know that > the NRTL's in the USA (UL/ETL) specifically call out what tests are to be > performed after the production build of equipment. > Any input would be appreciated. > Thx > > Dick Grobner > Medical Graphics Corporation > 350 Oak Grove Parkway > St Paul MN 55127 > 651-766-3395 > 651-766-3389 (fax) > [email protected] > > > > ------------------------------------------- > This message is from the IEEE EMC Society Product Safety > Technical Committee emc-pstc discussion list. > > Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ > > To cancel your subscription, send mail to: > [email protected] > with the single line: > unsubscribe emc-pstc > > For help, send mail to the list administrators: > Michael Garretson: [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.rcic.com/ click on "Virtual Conference Hall," > > ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson: [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.rcic.com/ click on "Virtual Conference Hall,"
