> 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. >
Hi Joe, I think these are what you're looking for: Directive: Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices Standard: prEN 61010-2-101:2001 (IEC 61010-2-101:2002) Safety requirements for electrical equipment for measurement, control, and laboratory use -- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment Matt To: [email protected] [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"
