Case study of AC adapter for medical devices

Regarding Compatibility of AC Adapters with Medical Devices

Recently, with advances in medical technology and the aging population in Japan, there has been increasing attention on the medical field. As medical devices evolve, we often hear about various companies entering the healthcare sector. Considering factors such as technological advancements and user-friendliness, products are becoming more compact and multifunctional, leading to the practical implementation of various measuring instruments for medical purposes.

Along with these technological and product developments, the demand for AC adapters has steadily increased. Common examples include blood pressure monitors, blood glucose meters, nebulizers, moxibustion devices, massage machines, and colposcopes.

In Japan, according to the Pharmaceutical Affairs Law,

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

Products that fall under these categories which use AC adapters require certification as a set of the device and the AC adapter.

We believe that regulatory compliance for these types of devices will increasingly become more important in the future.

To meet this demand, UNIFIVE offers a lineup of AC adapters that are certified to IEC60601. Regarding compliance with the Pharmaceutical Affairs Law, we work closely with our customers to determine how to address areas that overlap with PSE during development and sales, sharing necessary information and cooperating accordingly.

Even for models not listed in our catalog, we are open to flexible solutions such as modification or customization, depending on the issue. Please feel free to consult us if you need help selecting an AC adapter.

Example of AC Adapter for Massage Equipment

A customer planning to submit an application under the Pharmaceutical Affairs Law for a massage device was considering which AC adapter to use, and we handled the development. At the beginning of the project, we worked with the customer to confirm the required performance and reliability of the AC adapter and the policy for compliance with the Pharmaceutical Affairs Law. For reference, massage devices require compliance with JIS C 9335.

In the case of JIS C 9335, the standard method typically involves verifying that the transformer in the AC adapter complies with IEC61558. However, after the customer confirmed with the certification body that would conduct the tests, they concluded that it was acceptable to use our AC adapter’s IEC60601 CB Report for evaluation.

Based on this, we recommended our UM312 series AC adapter for medical use and began verification. Although we had to change some components to meet the customer’s performance requirements, the parts were within the registered component category in the CB Report’s list of critical components, so modification rather than full customization was sufficient, and the customer successfully completed their evaluation.

Later, the customer submitted the AC adapter and their device together to the certification body, and mass production was successfully completed on the scheduled date.

Lineup of Products Certified for IEC60601-1-2:2014 “Edition 4”

We provide a wide range of medical-grade AC adapters and can propose the most suitable model for your needs. USB-type models certified under medical standards are also available.

If you are considering using an AC adapter for a medical device, please don’t hesitate to contact us.

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

The Ministry of Health, Labour and Welfare has already issued a notice, so many of you may be aware that the certification review standards have been revised with the issuance of JIS T0601-1:2017.

The evaluation period for certification under the old version, JIS T 0601:2012, ended on February 28, 2019. From then on, JIS T0601-1:2017 is applied during certification evaluations. UNIFIVE’s medical adapter series is compliant with IEC60601, a standard that satisfies JIS T0601-1:2017.

In evaluations under JIS T0601, the medical device and adapter are assessed as a set. Therefore, if a document (CB Report) showing that the adapter complies with the standard is submitted, tests specifically for the adapter can be waived, leading to a smoother certification process.

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