'IEC 62353 Medical Electrical Equipment - recurrent test and test after repair of medical electrical equipment', defines requirements to ensure the in-service electrical safety of electromedical equipment and systems.
The new booklet is designed for biomedical engineering personnel, medical equipment service engineers and manufacturers of medical devices. It explains the requirements of the standard in easy to follow terms and provides all the relevant information in relation to commonly used definitions, symbols, different leakage measurements, schematics, pass/fail limits, single fault conditions and other details.
Importantly IEC 62353 incorporates tests beyond those of type testing. Specifically it seeks to provide a uniform and unambiguous means of assessing the safety of medical equipment, whilst maintaining the relation to IEC 60601-1 manufacturing standard and minimising the risks to the person conducting the assessment.
The new standard recognises that the laboratory conditions described in IEC 60601-1 cannot always be guaranteed when in-service testing of medical devices is undertaken. As a result, test measurements that require certain environmental conditions may not always be applicable or consistent for the testing of equipment that is already in use.
The handy A5 booklet produced by Rigel explains these and other matters. In doing so it is designed to provide a useful insight for both new and experienced users of electrical safety test equipment and a simple reference guide to issues relating to everyday testing.