Case of AC adapter for medical devices

AC/DC Power Adapters — Desktop & Wall-Mount Compatibility with Medical Devices

Recently, with advancements in medical care and the aging population in Japan, attention has been focused on the medical field. As medical devices have evolved, it is common to see various companies entering the healthcare market. Considering technological progress and ease of use, Products have become smaller and multifunctional, leading to the commercialization of various diagnostic devices for medical use.

Alongside this technological progress and evolution of Products, demand for AC/DC Power Adapters — Desktop & Wall-Mount has steadily increased. Common examples include blood pressure monitors, blood glucose meters, nebulizers, moxibustion instruments, massage devices, and colposcopes.

In Japan, under regulations for pharmaceutical and medical devices, the following standards must be complied with:

• Controlled medical devices: JIS C9335 (equivalent to IEC60335)
• Highly controlled medical devices: JIS T0601 (equivalent to IEC60601)

For Products falling under these categories and using AC/DC Power Adapters — Desktop & Wall-Mount, certification is required for the set of the AC/DC Power Adapters — Desktop & Wall-Mount and the device.

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

At UNIFIVE, we offer a lineup of AC/DC Power Adapters — Desktop & Wall-Mount Products that are certified with IEC60601, in response to such demand. In dealing with the regulations for medical devices, including overlapping areas with PSE, we work closely with our customers during development and sales to ensure proper compliance.

Even for models not listed in our catalog, we may be able to solve issues through modifications or custom solutions, and we are open to flexible responses. If you are struggling with selecting an AC/DC Power Adapters — Desktop & Wall-Mount, please do not hesitate to contact us.

Example of AC/DC Power Adapters — Desktop & Wall-Mount for Massage Devices

A customer approached us for the development of an AC/DC Power Adapters — Desktop & Wall-Mount when applying for their massage device under the medical device regulations. At the beginning of the project, we confirmed with the customer the required performance and reliability of the AC/DC Power Adapters — Desktop & Wall-Mount as well as their strategy for compliance. Notably, massage devices must comply with JIS C 9335.

In the case of JIS C 9335, the standard approach would require conformity with IEC61558 for the transformer in the AC/DC Power Adapters — Desktop & Wall-Mount. However, when the customer inquired with their certification body, they were informed that certification could be evaluated using our AC/DC Power Adapters — Desktop & Wall-Mount’s existing IEC60601 CB Report.

Therefore, we recommended our medical-use AC/DC Power Adapters — Desktop & Wall-Mount UM312 series and began verification. Some components needed to be replaced to meet specific performance requirements, but since these were within the range of components already listed on the CB report's critical component list, only a modification was required, not a full custom design. The customer's evaluation was completed successfully.

Later, the customer applied for certification of the AC/DC Power Adapters — Desktop & Wall-Mount and device as a set through an accredited certification body and was able to complete volume production on schedule.

Lineup of Products Compliant with IEC60601-1-2:2014 "Edition 4"

We offer a wide range of medical AC/DC Power Adapters — Desktop & Wall-Mount models and can propose the most suitable options for our customers. We also handle models with medical certification in USB types.

If you are considering a AC/DC Power Adapters — Desktop & Wall-Mount for medical equipment, feel free to .

Revision of Certification Evaluation Standards Following the Release of JIS T0601-1:2017

You may already know through a notice issued by the Ministry of Health, Labour and Welfare, but the standards for certification evaluations have been revised following the release of JIS T0601-1:2017.

The duration in which certification evaluations can be conducted under the old version, JIS T 0601:2012, ended on February 28, 2019. From then on, JIS T 0601-1:2017 has been applied during certification evaluations. UNIFIVE's medical application adapter series has a lineup that is certified with IEC60601, meeting the standards of JIS T0601-1:2017.

Under JIS T0601, the evaluation is conducted with the customer's medical device and adapter as a set. Therefore, if documentation (CB Report) showing that the adapter itself is certified with this standard is available, testing related solely to the adapter can be exempted, facilitating smoother set certification evaluations.

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