JIS T 0601-1 Medical Electrical Equipment, Part 1: General Requirements Test Standard for Essential Safety and Essential Performance

Medical Device Tests

JIS T 0601-1 Medical Electrical Equipment, Part 1: General Requirements Test Standard for Essential Safety and Essential Performance

EUROLAB laboratory provides testing and compliance services within the scope of JIS T 0601-1 standard. JIS T 0601-1 is a set of technical standards for the safety and effectiveness of medical electrical equipment.

JIS T 0601-1 Medical Electrical Equipment, Part 1: General Requirements Test Standard for Essential Safety and Essential Performance

The JIS T 0601-1 standard has a significant impact on the product development process, going beyond performance testing and verification. This is because product complexity often provides numerous potential test scenarios, permutations, and combinations in both normal and abnormal operating modes, and these cannot be evaluated only in the final design.

Although power supplies are not medical devices in their own right and are therefore not directly covered by the JIS T 0601-1 directive, they are nevertheless an integral part of the design and operation of medical equipment.

The unique nature of an ac-dc power supply or a dc-dc converter means that the voltages and currents they supply can be potentially dangerous if not properly managed.

EUROLAB assists manufacturers with JIS T 0601-1 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.

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