Full Custom Support Case Studies for Medical Device AC/DC Power Adapter | IEC60601/Pharmaceutical and Medical Device Act Compliant

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

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 standard 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 unique to medical devices
Coexistence with surrounding medical equipment
Ensuring safety in electromagnetic environments

Designs that take these factors into consideration 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. The new standard has been applied since then.

UNIFIVE's medical-use AC/DC Power Adapter include a lineup already certified to IEC60601 and compliant 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:

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

These strategies are important.

Cases Where Full Custom Support Is Appropriate

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 AC/DC Power Adapter for medical devices from two approaches: rapid standards compliance through semi-custom solutions and optimized design through full custom support.