Notice of Expansion of CB Certification Issuance Scope for Medical Device Testing (IEC 60601-2-37)
The organization has registered the international standard: IEC 60601-2-37 (Particular requirements for the basic safety and essential performance of medical ultrasonic diagnostic and monitoring equipment) as the scope for issuing CB certificates, thereby expanding the scope of CB certificate and CB report issuance.
● Category
MED (Medical Devices)
● Standard Numbers
(1) IEC 60601-2-37:2007
(2) IEC 60601-2-37:2007/AMD1:2015
Our organization offers a wide range of services related to testing and certification for medical devices, including electrical safety testing and electromagnetic compatibility testing based on the IEC 60601-1 series, certification based on the Pharmaceuticals and Medical Devices Act (PMD Act), support for obtaining overseas certifications in Europe, North America, China, and management system certification based on ISO 13485. We propose a total solution for testing and certification related to medical devices. Please consider our medical device-related services.

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International standard: IEC 60601-2-37 (Particular requirements for the basic safety and essential performance of medical ultrasonic diagnostic and monitoring equipment) has been registered as the scope for the issuance of CB certificates, and the scope of issuance for CB certificates and CB reports has been expanded.
Tests are conducted based on domestic and international standards. As an NCB (National Certification Body) under the IECEE-CB system, we will issue CB certificates, reports with the ILAC logo based on ILAC-MRA, and test result certificates. Additionally, we also accept technical inquiries regarding standards for medical electrical equipment.






