Semi-custom case study of AC/DC Power Adapter for medical devices | IEC60601･JIS compliant Copy

A semi-custom support case for medical device AC/DC Power Adapter. We introduce a real example where IEC60601-certified AC/DC Power Adapter units were utilized to smoothly achieve compliance with JIS standards and the Pharmaceuticals and Medical Devices Act.

AC/DC Power Adapter Approach to Medical Device Compliance

With recent advances in medical technology and the progression of an aging society, new market entry and product diversification in the medical device field are increasing. Even in familiar medical and healthcare devices such as blood pressure monitors, blood glucose meters, nebulizers, moxibustion devices, and massage equipment, the adoption of AC/DC Power Adapter has become common.

When using an AC/DC Power Adapter for medical devices in Japan, it is necessary under the Pharmaceutical and Medical Device Act (PMD Act) to evaluate and certify the device and power supply as a set.

Medical Device Classification and Applicable Safety Standards

In Japan, the following safety standards apply depending on the classification of the medical device.

Controlled Medical Devices → JIS C 9335 (equivalent to IEC60335)
Specially Controlled Medical Devices → JIS T 0601 (equivalent to IEC60601)

When using an AC/DC Power Adapter, certification evaluation is required not for the device alone but for the combination of the AC Adapter and the device.

What Is Semi-Custom Support (For Medical Applications)

In medical applications, semi-custom support refers to making minimal adjustments to component configuration and specifications based on an AC/DC Power Adapter that has already obtained IEC60601 certification.

No complete redesign of the circuit
Adjustments within the range of components registered in the CB report
Emphasis on smooth certification acquisition

This makes it possible to reduce certification workload, cost, and schedule risks.

Semi-Custom Case Study | AC Adapter for Massage Equipment

A customer consulted us regarding the selection of an AC/DC Power Adapter when applying for PMD Act approval for massage equipment.

In this case, we first organized the following points.

Required performance and reliability
Applicable standards (JIS C 9335)
Evaluation policy of the certification body

In the case of JIS C 9335, compliance confirmation with IEC61558 for transformers is generally required, but after consultation with the certification body, it was determined that evaluation using the IEC60601 CB report was possible.

Solution Through Modification Support

We proposed our medical-use AC/DC Power Adapter UM312 Series and began evaluation.

Partial component replacement to meet performance requirements
Changes kept within the critical component scope of the CB report

As a result, evaluation was completed with modification support only, without custom development, and the customer successfully applied to the certification body with the AC/DC Power Adapter and device as a set, leading to mass production.