Case of AC/DC Power Adapter for medical devices

We introduce AC/DC Power Adapter Products for medical equipment and their case studies. We offer models compliant with the latest medical standard IEC60601-1-2:2014 (4th edition) as well as models compliant with EN60601-1-2:2015, and we will continue to expand our lineup.

AC/DC Power Adapter Compliance for Medical Devices

In recent years, with advances in medical care and the aging population in Japan, increasing attention has been focused on the medical field. As medical devices continue to evolve, it is common to hear about various companies entering the healthcare sector. In consideration of technological advancements and ease of use, Products have become smaller and more multifunctional, leading to the practical application of various measuring instruments for medical use.

With this technological progress and the evolution of Products, demand for AC/DC Power Adapter has steadily increased. Familiar examples include blood pressure monitors, blood glucose meters, nebulizers, moxibustion devices, massagers, and colposcopes.

In Japan, under the Pharmaceuticals and Medical Devices Act:

• Controlled medical devices must comply with JIS C9335 (equivalent to IEC60335)
• Specially controlled medical devices must comply with JIS T0601 (equivalent to IEC60601)

For Products that fall under these categories and use an AC/DC Power Adapter, certification is required for the set consisting of both the AC/DC Power Adapter and the device.

We believe that regulatory compliance requirements for such devices will continue to increase in the future.

UNIFIVE offers a lineup of AC/DC Power Adapter Products certified to IEC60601 to meet these demands. In responding to the Pharmaceuticals and Medical Devices Act, we work closely with our customers during sales and development, particularly regarding how to handle areas that overlap with PSE requirements during the compliance process.

Even for models not listed in our catalog, issues may be resolved through modifications or custom solutions, and we are able to provide flexible support. If you are having trouble selecting an AC/DC Power Adapter, please feel free to contact us.

Example of an AC/DC Power Adapter for Massage Equipment

A customer was applying for approval of a massage device under the Pharmaceuticals and Medical Devices Act and was having difficulty selecting an AC/DC Power Adapter, so we undertook the development. At the beginning of the project, we confirmed the required performance and reliability of the necessary AC/DC Power Adapter and the policy for compliance with the Act. Massage devices are required to comply with JIS C 9335.

In the case of JIS C 9335, it is generally necessary to confirm compliance of the AC/DC Power Adapter transformer with IEC61558. However, when the customer consulted the certification body conducting the certification test, they indicated that evaluation could be performed using our AC/DC Power Adapter's IEC60601 CB report for certification purposes.

Accordingly, we recommended our medical-use AC/DC Power Adapter, the UM312 series, and began verification. Based on the customer's performance requirements, some components were replaced. However, since they were within the scope of the registered components listed in the CB report's critical component list, only a modification was required rather than a full custom design, and the customer's evaluation was successfully completed.

Subsequently, the customer applied to the certification body for approval of the AC/DC Power Adapter and device as a set, and mass production of the Products was completed successfully according to the designated schedule.

Lineup Includes Products Certified to IEC60601-1-2:2014 4th Edition

We offer a wide lineup of medical-use AC/DC Power Adapter and can propose the optimal model for our customers. We also handle USB types that have obtained medical standards certification.

If you are considering an AC/DC Power Adapter for medical devices, we would appreciate the opportunity to hear from you.

Revision of Certification Review Standards Following the Issuance of JIS T0601-1:2017

As many of you may already know, since the Ministry of Health, Labour and Welfare has issued a notice, the review standards for certification applications have been revised following the issuance of JIS T0601-1:2017.

The period during which certification evaluation could be conducted under the previous version, JIS T0601:2012, ended on February 28, 2019. After that, JIS T0601-1:2017 is applied at the time of certification evaluation. UNIFIVE's medical adapter series includes a lineup certified to IEC60601, which conforms to JIS T0601-1:2017.

Evaluation under JIS T0601 is conducted with the customer's medical device and adapter combined as a set. Therefore, if documentation (CB report) demonstrating that this standard has been obtained for the adapter alone can be submitted, tests related solely to the adapter may be exempted, allowing the evaluation tests for set certification to proceed smoothly.

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