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
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