Examples of AC/DC Power Adapters for Medical Devices — Desktop & Wall-Mount

Regarding Compatibility of AC/DC Power Adapters — Desktop & Wall-Mount for Medical Devices

In recent years, due to advancements in medical technology and the aging population in Japan, the medical field has garnered increased attention. As medical devices continue to evolve, it is common to hear about various companies entering the healthcare sector. Taking into account technological advancements and usability, products are becoming more compact and multifunctional, leading to the practical use of a variety of measuring instruments for medical purposes.

Alongside these technological and product developments, the demand for AC/DC Power Adapters — Desktop & Wall-Mount is steadily increasing. Common examples include blood pressure monitors, glucose meters, nebulizers, thermal acupressure devices, massage equipment, and colposcopes.

In Japan, under the Pharmaceutical and Medical Device Act:

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

For products that fall into these categories using AC/DC Power Adapters — Desktop & Wall-Mount, certification of both the adapter and the device as a set is required.

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

At Unifive, to meet such demand, we offer a lineup of AC/DC Power Adapters — Desktop & Wall-Mount products certified to IEC60601. In complying with the Pharmaceutical and Medical Device Act, we collaborate closely with our customers during development and sales to address overlapping requirements with PSE and determine the appropriate responses.

Even for models not listed in the catalog, we may be able to offer solutions through modifications or customizations, allowing for flexible responses. If you are unsure about selecting AC/DC Power Adapters — Desktop & Wall-Mount, please feel free to contact us.

Case Study: AC/DC Power Adapters — Desktop & Wall-Mount for Massage Devices

A customer approached us while applying for certification under the Pharmaceutical and Medical Device Act for a massage device and needed assistance selecting the appropriate AC/DC Power Adapter — Desktop & Wall-Mount. At the start of the project, we confirmed the required performance and reliability of the AC/DC Power Adapter — Desktop & Wall-Mount and the approach for regulatory compliance. Note that massage devices must comply with JIS C9335.

In the case of JIS C9335, it is standard practice to confirm compliance of the adapter's transformer with IEC61558. However, upon the customer’s inquiry with the certification body, it was determined that our AC/DC Power Adapter — Desktop & Wall-Mount, which is certified under IEC60601 with a CB report, could be used for evaluation.

As a result, we recommended our UM312 series, a medical-use AC/DC Power Adapter — Desktop & Wall-Mount, and began validation. Due to specific performance requirements, some components were swapped, but since these were within the registered critical component list in the CB report, a modification (not full customization) sufficed and the customer’s evaluation was successfully completed.

Subsequently, the customer submitted the adapter and device as a set to the certification body and was able to complete mass production on schedule.

Lineup Includes Models Certified to IEC60601-1-2:2014 "Edition 4"

We offer a wide range of medical AC/DC Power Adapters — Desktop & Wall-Mount and can suggest the optimal model for your needs. We also handle USB types that are certified for medical standards.

If you are considering AC/DC Power Adapters — Desktop & Wall-Mount for medical devices, we invite you to contact us for consultation.

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

As many of you may already be aware, the Ministry of Health, Labour and Welfare has announced that following the publication of JIS T0601-1:2017, the certification review standards have been revised.

The period during which certification evaluations could be conducted using the previous JIS T0601:2012 was until February 28, 2019. Thereafter, JIS T0601-1:2017 must be applied for certification evaluations. Unifive’s medical adapter series include products certified to IEC60601, which satisfies the specifications of JIS T0601-1:2017.

Evaluation under JIS T0601 is conducted with the medical device and adapter as a set. Therefore, by submitting a document (CB report) indicating that the adapter alone meets these standards, adapter-only tests can be omitted, making the set certification process smoother.

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