Greetings, We currently manufacture and market a product as laboratory equipment not intended for diagnostic purposes. This product has been evaluated to EN 61010-1, EN 61326, CSA 1010.1 and UL 3101-1.
We are considering marketing this product as an "In-vitro diagnostic" device. Do we need to re-evaluate this product to a different set of standards? If so, which Directives/standards are applicable. All responses are greatly appreciated. Regards Joe Martin Applied Biosystems [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: 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://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list"
