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Manufacturers need to demonstrate compliance with regulations regarding safety and performance requirements to ensure product safety and market entry.

The conformity of medical devices to EMC has recently become a significant issue, as it can pose a threat to life. If a product does not conform to the intended environment, it becomes difficult to ensure safety compliance and to achieve its intended effects. EMC testing evaluates the potential for interference between nearby products and the risk of injury or damage to people and the surrounding environment. Additionally, these tests assess the compatibility of devices under the intended electromagnetic environment. In many countries, EMC, radio, and radio frequency (RF) exposure and safety requirements are established. For medical products, several standards are set regarding testing, risk management, basic safety, and essential performance. For example, medical devices sold in the United States must comply with IEC 60601-1-2, 4th edition. The IEC 60601-1-2, 4th edition defines the fundamental safety and essential performance of medical devices concerning radiation and immunity to electromagnetic interference. As of the latest information, the U.S. Food and Drug Administration (FDA) has recognized the 4.1 edition as a Recognized Consensus Standard in December 2023.

One-stop service for on-site measurements, requests, and compliance with radio laws in various countries.

【Testing Facilities】 - Kashima EMC Testing Facility - Shonan EMC Testing Facility - Ise Headquarters EMC Testing Facility (+ Large Mobility Testing Building) - Yokowa EMC Testing Facility - Automotive Technology Center To meet the diverse needs of different products, UL Solutions offers testing through the following methods. We will propose options tailored to our internal resources and the characteristics of the products. ■ Commissioned Testing (Outsourced Testing) Customers provide their products, and our engineers conduct the testing. Since we handle all processes in-house, we can reduce the burden on our customers. ■ Witness Testing Similar to commissioned testing, our engineers perform the tests. Customers can be present during the testing process. ■ On-Site Testing For products that are difficult to transport to the testing facility, such as large equipment, our engineers will visit the factory or installation site directly to conduct the tests. *For more details, please refer to the PDF document or feel free to contact us.