Medical Devices: Introduction of Class I and Class II input

Brian Lu / MWUSA

In effort to reduce healthcare services cost and deliver affordable treatments to patients, medical device manufactures are focusing to develop or redesign medical devices that can be used at home without the service of trained professional. According to the IEC-6060-1-11 standard, such medical equipment called “Home Healthcare Device” that used in home environment by patients or lay operators. Because of home environment operation, residential power outlets might not have reliable grounding or be built without grounding. Therefore, the standard requires Home Healthcare Device to design with Class II input. In other words, the device AC plug must be two prongs type as shown in Figure 1.

Class II Home Healthcare Devices range from low-power Nebulizer to mid-power Peritoneal Dialysis. It’s worth noting that low-power Healthcare Device usually provides with a Class II Medical Grade External Adaptors. Mid-power Healthcare Device can either provide with an external adaptor or design with Class II inlet (IEC-320-C8), which internally wired to a Class II input Medical Grade Power Supply. Therefore, it’s critical for Home Healthcare Medical Device to have a Class II input Medical Grade External Adaptors or Medical Grade Power supply.

Class II Home Healthcare Device is a great step to help patients reducing healthcare cost. Meanwhile, Healthcare Device that operates in Hospital Environment is usually designed with Class I AC plug or IEC-320-C14 inlet. These AC plug or inlet is three prongs type with ground pin. In fact, it is required by the National Electric Code (NEC) Article 517.19 that inpatient bed or procedure bed locations outlet must use Hospital Grade Type, which shows in Figure 2.

Interestingly, Hospital Grade type AC outlet or plug is made with a circular green dot signified the essential of grounding, which implies Healthcare Devices operating within these environments must be grounded, Class I Type. Therefore, Class I Medical Grade Power Supply is required for Hospital Environment Medical Device. Such Healthcare Devices are ECG Patient Monitor or Electrical Patient Bed… etc.

MEAN WELL offers wide range of Medical Grade Power Supplies including External Adaptors 6W~220W (Class I & II), Open-Frame Type 5W~400W (Class I & Class II) and Enclosed Type (Class I) 100~1200W. The Class I Enclosed Type is certified to IEC-60601-1, ANSI/AAMI ES60601-1 and 2xMOOP level (100~1000W single output) with low leakage current suitable for Laboratory Devices and 2xMOPP (650~1200W multiple outputs Modular type) suitable for type BF Medical Devices.

The Class I and II External Adaptors and Open-Frame Type are EN 60601-1/-11, ANSI/AAMI ES60601-1/-11 certified 2xMOPP level and low leakage current suitable for Home Healthcare and Hospital based Environments. Please visit MEAN WELL’s Medical Power Supply webpage for details: LINK.