Classification of Specific Applications of Electronic Components for Medical Equipment

We classify the specific applications of electronic components for medical equipment according to the international classification stipulated by the Global Harmonization Task Force (GHTF)^*, and have set reliability standards and established quality systems according to their application.
Our quality system for each GHTF classification applies to electronic components for medical equipment, and does not guarantee suitability, performance, quality, etc. to the finished medical equipment application.

*The current activities have been replaced by the International Medical Device Regulators Forum (IMDRF).

Depending on the application of electronic components for medical equipment, malfunctions may directly endanger lives. If you intend to use our electronic components for medical equipment, please be sure to contact our sales representative to confirm the reliability standards and quality system for each product. If you use our electronic components for specific applications other than those for which they are intended, we will not be liable for any unexpected accidents or other damage resulting from such use.

In each country, classification has been stipulated for each finished medical equipment application, as shown in the examples below. Please contact our sales representative for information on the relationship between the laws and regulations of each country and the GHTF class.

Medical equipment in Japan is classified into Class Ⅰ, Ⅱ, Ⅲ, and Ⅳ according to the Act on Pharmaceuticals and Medical Devices (Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices) stipulated by the Ministry of Health, Labour and Welfare.
Medical equipment in Europe is classified into Class Ⅰ, Ⅱ (a), Ⅱ (b), and Ⅲ according to the Medical Devices Regulation (MDR) stipulated by the competent authorities in the EU.
Medical equipment in the U.S. is classified into Class Ⅰ, Ⅱ, and Ⅲ according to the Federal Food, Drug, and Cosmetic Act (FFDCA Act) stipulated by the U.S. Food and Drug Administration (FDA).

GHTF class	Application Example	Definition	Applicable classes and the specific applications of our products
A	Surgical microscopes and surgical lighting equipments	Equipment that, in the event of a malfunction, is considered to pose an extremely low risk to the human body.	Please contact us for details, as applicable classes and the specific applications differs for each product.
B	Sphygmomanometers, diagnostic imaging systems, and thermometers	Equipment that, in the event of a malfunction, is considered to pose a comparatively low risk to the human body.
C	Insulin infusion pumps and glucose meters	Equipment that, in the event of a malfunction, is considered to pose a comparatively high risk to the human body.
D	Cardiac pacemakers and implantable defibrillators	Equipment that is highly invasive to the patient and may directly lead to life-threatening consequences in the event of a malfunction.

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Classification of Specific Applications of Electronic Components for Medical Equipment