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View Full Version : CE Mark / TCF (Technical Construction File) File sample

achih100
29th December 2007, 02:44 AM
can anyone send me a sample of TCF file (for CE mark)? Medical directive /MDD）93/42/EEC is best. Thanks!

Jessica
harry
29th December 2007, 04:08 AM
can anyone send me a sample of TCF file (for CE mark)? Medical directive /MDD）93/42/EEC is best. Thanks!

Jessica

Have a look at the 'Similar Threads' box below, especially this thread: Technical File for CE declaration - Template or Sample of required contents
(http://elsmar.com/Forums/showthread.php?t=19806)
Ajit Basrur
29th December 2007, 04:58 AM
can anyone send me a sample of TCF file (for CE mark)? Medical directive /MDD）93/42/EEC is best. Thanks!

Jessica

Hi Jessica,

Welcome to the Cove. In addition to the suggestions that my friend Harry has give, I am attaching a Guidance Document Technical Files / Design Dossiers Non Active Medical Devices (http://www.tuev-sued.de/uploads/images/1134987012631647513549/MHS2%20Non%20Active%20Medical%20Devices-Products.pdf), issued by TUV.

Another not so relevant but appropriate example is CE MARK TECHNICAL FILE / AUSTRALIA EMC CONSTRUCTION FILE of Personal Computer (http://global.aopen.com/tech/certific/ce/housing/h300/ce-h300.pdf)