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,"
