Full custom support case for medical devices AC/DC Power Adapter | IEC60601･Pharmaceutical and Medical Device Act compliance

A case study of full custom support for AC/DC Power Adapter for medical devices. Assuming compliance with IEC60601 and JIS T0601-1, we introduce a real example of power supply development optimized from the design stage.

What Full Custom Support Means (Medical Applications)

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

It is selected in the following cases:

When existing Products or semi-custom options 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

With the issuance of JIS T0601-1:2017, evaluations under the previous version (JIS T0601:2012) were valid until February 28, 2019, and the new standard has been applied thereafter.

UNIFIVE's medical AC/DC Power Adapter include a lineup certified to IEC60601 that complies with JIS T0601-1:2017.

Certification Strategy for Full Custom Support

Evaluation under JIS T0601 is conducted for 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

Such strategies are crucial.

Cases Where Full Custom Support Is Suitable

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

UNIFIVE supports solving challenges related to medical AC/DC Power Adapter from two approaches: rapid standards compliance through semi-custom solutions and optimized design through full custom solutions.