Joe, The standards you mention are not part of the applicable Medical Device Directive (MDD)- General (93/42/EEC) and In Vitro Diagnostic (98/79/EEC)
See attached links for standards applicable under these MDD Directives. http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/re flist/meddevic.html http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/re flist/invimedd.html This e-mail message may contain privileged or confidential information. If you are not the intended recipient, you may not disclose, use, disseminate, distribute, copy or rely upon this message or attachment in any way. If you received this e-mail message in error, please return by forwarding the message and its attachments to the sender. PETER S. MERGUERIAN Technical Director I.T.L. (Product Testing) Ltd. 26 Hacharoshet St., POB 211 Or Yehuda 60251, Israel Tel: + 972-(0)3-5339022 Fax: + 972-(0)3-5339019 Mobile: + 972-(0)54-838175 http://www.itl.co.il http://www.i-spec.com -----Original Message----- From: Joe P Martin [mailto:[email protected]] Sent: Friday, August 02, 2002 12:04 AM To: [email protected] Subject: In-Vitro Diagnostic Equipment 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" ------------------------------------------- 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"
