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.