PSE Mark Approved Medical (60601-1) Power Supply/AC Adapters meet Japan DENAN regulations for import and sale in Japan

Medical IEC60601-1 power supplies in standard and custom configurations are offered in a wide range which comply with and are certified to meet Japan/Japanese PSE/DENAN regulations for medical devices. DENAN is a mandatory national law administered by Japan’s METI (Ministry of Economy, Trade and Industry), which was formerly called the Electrical Appliance and Material Control Law (“DENTORI”). Medical equipment is generally regulated by Japan’s Pharmaceutical Affaire Law (PAL), PAL would require a PSE approved power supply to give onward certification on the system level for medical devices. For Medical 60601-1 DC Power Supplies exported to Japan, the DENAN “DENAN symbol” approval is required. AC/DC power supplies are considered a 'Category A' product with means they are specified products and require a diamond PSE Mark for use in Japan. These specified electrical appliances are either required to undergo third-party conformity assessment, and obtain their certificate, or obtain “the equivalent of a certificate” through the manufacturers of the specified electrical appliances concerned. The Notifying Supplier (importer) is responsible for ensuring that the product is tested in accordance with the requirements by a RCAB (or “Registered Conformity Assessment Body”).

As Japan is a key export market for GlobTek Medical equipment and instrumentation customer’s, a wide range of Medical 60601-1 Power Supplies and AC Adapters have been certified with PSE approval. The below table outlines GlobTek’s current PSE certification for both Class I and Class II power supplies. Both 2xMOOP and 2xMOPP options available to cover all types of applications. The certifications are based on the combination of input power and output voltage so certification is including the listed “base model” but not limited to it.

A procedure is available for proper importation of GlobTek's PSE Mark certified Power supplies, AC Adapters, and power cords:

Please contact GlobTek for a copy of our certification for a specific model or to inquire with any questions or requirements you may have.


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