IEC EN 62353: “RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT.”
Pertains to testing of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS, or parts of such equipment or systems, which comply with IEC 60601-1-1988 (second edition) and its amendments and IEC 60601-1-2005 (third edition) and its amendments, before PUTTING INTO SERVICE, during MAINTENANCE, INSPECTION, SERVICING and after REPAIR or on occasion of RECURRENT TESTS to assess the safety of such ME EQUIPMENT or ME SYSTEMS or parts thereof.
Service providers who operate electrical medical devices must assure that they’re safe for users and patients. Assuring safe operation includes subjecting such devices to necessary testing in accordance with the current state-of-the-art. As of May 2007, IEC 62353 has been added to the scope of required testing in a uniform fashion around the world. This new standard is based on VDE 0751 which has been valid in Germany and Austria for many years, into which changes embodied in IEC 62353 have since been incorporated.
WHICH DEVICES ARE TESTED IN ACCORDING WITH IEC 62353?
The standard applies only to the testing of electrical medical devices or systems, as well as components included in such devices or systems, which comply with IEC 60601-1.
The range of applications for devices manufactured in accordance with IEC 60601-1 grows immensely each year. Nearly all devices offered in these areas have to be tested in accordance with IEC EN 62353. The standard also allows for the testing of devices which are not manufactured in accordance with IEC 60601-1, thus expanding the range of applications to devices which would otherwise be tested per IEC EN 62353 as well.