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.

PSE Certificate No.Input Power (VA)Output VDCBasic modelClass
PSE1009022610< VA ≤20DC ≤ 15VGT-41076-0606II
PSE1009019030< VA ≤40
40< VA ≤50
DC ≤ 15VGT-41062-1812-T2II
PSE1009025020< VA ≤30DC ≤ 15VGT-41052-1509II
PSE1009018940< VA ≤50
50< VA ≤60
DC ≤ 15VGT-41062-1806-T2II
PSE1009019130< VA ≤40DC 15 ≤ 30VGT-41062-1818-T2II
PSE1009019140< VA ≤50DC 15 ≤ 30VGT-41062-1824-T2II
PSE1009024230< VA ≤40
40< VA ≤50
DC 30 ≤ 60VGT-41052-1548II
PSE10090186100< VA ≤ 200DC ≤ 15VGT-41069P9012T2II
PSE1109037980< VA ≤90
90< VA ≤100
DC 15 ≤ 30VGT-41083-4024-T2II
PSE1209051420< VA ≤30
30< VA ≤40
DC ≤ 15VGT-41135-1205II
PSE1009019940< VA ≤50
50< VA ≤ 60
DC ≤ 15VGT-41062-1806-T3I
PSE1009018760< VA ≤ 70
70< VA ≤ 80
DC ≤ 15VGT-21097-3005I
PSE1009019780< VA ≤90
90< VA ≤100
DC ≤ 15VGT-21097-5012I
PSE1009019230< VA ≤40DC 15 ≤ 30VGT-41062-1824-T3 T3AI
PSE1009019240< VA ≤50DC 15 ≤ 30VGT-41062-1818-T3 T3AI
PSE10090198100< VA ≤ 200DC 15 ≤ 30VGT-21097-5024I
PSE1009018890< VA ≤100
100< VA ≤200
DC 30 ≤ 60VGT-21097-5048I
PSE10090241100< VA ≤ 200DC ≤ 15VGT-41069P9012-T3I
PSE1109040310< VA ≤20DC ≤ 15VGT-51084-12N12
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