EMC testing services for medical devices and in vitro diagnostic medical devices.
From July 2023, compliance with EMC standards for medical devices (JIS T 0601-1-2:2023) and various EMC standards for IVD devices will be implemented.
To manufacture and sell medical devices and in vitro diagnostic medical devices (IVD devices), it is necessary to meet international regulations and standards. The required criteria vary by country, and TÜV SÜD Japan provides testing and certification services, as well as training services, to comply with these regulations. In particular, EMC testing is an essential requirement for electrical and electronic devices, evaluating whether they emit unnecessary electromagnetic waves that interfere with the operation of other devices (emission) and whether they have the ability to withstand other electromagnetic interference (immunity). TÜV SÜD is accredited as a notified body based on EU directives for EMC testing, and the TÜV SÜD Japan Yonezawa Testing Laboratory (located in Yonezawa City, Yamagata Prefecture) is registered as an ISO/IEC 17025 accredited laboratory for domestic and international EMC standards.
- Company：テュフズードジャパン 東京本社
- Price：Other
