Safety test

Within the scope of the safety test the essential safety aspects of the general safety requirements of the medical devices law (regulation) EN 60601-1 are verified. It is not as extensive as the type-examination and does not comprise any tests such as examination of overcharge, heating or electric strength which could damage the device under test.
 

The basic test is intended

  • in sufficient time before the beginning of mass production of medical devices in order to minimize the manufacturers risk of time-consuming and costly corrective measures or product recall after the start of the mass production of a medical device

  • for the permission of clinical investigations through the ethics committee 

  • prior to the beginning of routine verification test of the ongoing production

  • before takeover of sales management (sales and marketing activities) of devices from suspect production facilities to minimize the distributors commercial risk

For information and inquiries please contact us at pmgnoSpam@tugraz.at or by phone at +43 (0)316/873-7395 or +43 (0)316/873-7398.

Dear Sir and Madam, for a quote, please go to the German webpage.

Contact
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European Testing Center of Medical Devices at the Institute of Health Care Engineering

Stremayrgasse 16/I
A-8010 Graz

Phone.: +43 (0) 316 / 873 - 7395
or +43 (0) 316 / 873- 7398
Fax: +43 (0) 316 / 873 - 4461

pmgnoSpam@tugraz.at
www.tugraz.at/arbeitsgruppen/pmg

Head:
Assoc.-Prof. Dipl.-Ing. Dr.techn. Jörg Schröttner

Vice Head:
Univ.-Prof. Dipl.-Ing. Dr.techn. Christian Baumgartner
Ing. Robert Neubauer

Opening hours
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MO - TH: 8 a.m. - 4 p.m.
FR: 8 a.m. - 12 p.m.