Full custom support case study of AC/DC Power Adapter for medical devices | IEC60601 and PMD Act compliant

A case study of full custom support for medical device AC/DC Power Adapter. Introducing a real-world example of power supply development optimized from the design stage, based on compliance with IEC60601/JIS T0601-1.

What Full Custom Support Means (Medical Applications)

Full custom support refers to optimizing the circuit design from the ground up, based on safety standards, Pharmaceutical and Medical Device Act requirements, and the intended usage environment.

It is selected in the following cases:

When existing Products or semi-custom solutions cannot meet requirements
Long-term use and high reliability are essential
When regulatory requirements significantly impact the design

IEC60601-1-2:2014 (4th Edition) Compliant Lineup

UNIFIVE offers a lineup of IEC60601-1-2:2014 (EMC standard, 4th edition) certified AC/DC Power Adapter.

Strict EMC requirements specific to medical devices
Coexistence with surrounding medical equipment
Ensuring safety in electromagnetic environments

Designs that take these factors into account are possible.

Response to Revised Review Standards Following the Issuance of JIS T0601-1:2017

JIS T0601-1:2017 was issued, and evaluations under the previous version (JIS T 0601:2012) were valid until February 28, 2019. Since then, the new standard has been applied.

UNIFIVE's medical-use AC/DC Power Adapter include a lineup that has obtained IEC60601 certification and complies with JIS T0601-1:2017.

Certification Strategy in Full Custom Support

Evaluation under JIS T0601 is conducted with the medical device and the AC/DC Power Adapter as a set.

Therefore, the following strategies are important:

Submission of a CB report for the AC/DC Power Adapter alone
Avoidance of duplicate testing
Streamlining set certification

These approaches are key considerations.

Cases Where Full Custom Support Is Suitable

Proprietary medical device designs
Use in highly controlled medical devices
Long-term supply and high reliability requirements
Strict EMC and safety standard requirements

UNIFIVE supports problem-solving for medical-device AC/DC Power Adapter through both rapid standards compliance via semi-custom solutions and optimized design through full custom support.