Paul, This is not from the EMC or LVD , but you mentioned 1010-1 which includes laboratory equipment, so for the medical directives, including the one for in vitro diagnostic medical devices, it is very clearly specified.
For the MDD, See article 4, paragraph 4 Member States may require the information, which must be made available to the user and the patient in accordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or other use. For the IVDD, See article 4, paragraph 4 Member States may require the information to be supplied pursuant to Annex I, part B, section 8 to be in their official language(s) when a device reaches the final user. Ned Ned Devine Program Manager III Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 616 248 9671 Phone 616 574 9752 Fax [email protected] e-mail -----Original Message----- From: Finn, Paul [mailto:[email protected]] Sent: Thursday, March 22, 2001 1:35 PM To: 'emc-pstc' Subject: Translation Requirements Can some one point out the specific requirements, if any, that are imposed on translating manuals into the language of the country they are to be used. Specifically if you CE label in accordance with 89/336/EEC (EN 61326) and 73/23/EEC (1010-1). In reviewing the archives I could only find mention that the manufacturer is to supply a version of the manual which is agreed upon in that country and English is most common. Your comments would be greatly appreciated. Paul Finn Panametrics Inc. ------------------------------------------- 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,"
