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.
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basic information
As of February 27, 2023, the latest version of the EMC standards (Pharmaceutical and Medical Device Safety Review No. 0227, Reiwa 5, February 27, regarding the handling of amendments to Japanese Industrial Standards on electromagnetic interference (electromagnetic compatibility) for medical devices) has been announced, allowing TÜV SÜD Japan to issue third-party accredited ILAC MRA (VLAC) reports. Consequently, starting from July 4, 2023, TÜV SÜD Japan's Yonezawa Testing Laboratory will be able to accommodate the following standards.
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Applications/Examples of results
1. Added to the EMC standards for medical devices: - JIS T 0601-1-2:2023 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests 2. Added to the EMC standards for in vitro diagnostic medical devices: - JIS C 61326-2-6:2023 Electrical equipment for measurement, control, and laboratory use - Electromagnetic compatibility (EMC) requirements - Part 2-6: Particular requirements - In vitro diagnostic medical devices - IEC 61326-2-6:2020 - EN IEC 61326-2-6:2021
Company information
TÜV SÜD is one of the world's largest third-party testing and certification organizations headquartered in Germany, providing certification, inspection, testing, and evaluation services across a wide range of fields. The company's Japanese subsidiary, TÜV SÜD Japan, was established in 1993 to respond to the growing demand for quality and safety testing and certification in the Japanese market under TÜV SÜD's business framework. It offers various testing, certification, auditing, management system certification, and training services in a wide range of fields, including electrical and electronic equipment, healthcare and medical devices, industrial equipment, IT and AV equipment, 5G-related devices, food, automotive, railways, energy and plant equipment, chemicals and processes, and cosmetics.