FEATURE POWER ELECTRONICS
IEC60601-1 4TH EDITION AND WHAT IT MEANS FOR POWER SUPPLIES IN MEDICAL SYSTEMS
Shane Callanan, director of applications engineering at Excelsys Technologies, discusses the IEC60601-1 4th Edition and the impact it has on power supplies for the medical industry, and what you should be aware of
different countries, so for a period both 3rd and 4th editions will be required. This poses a significant challenge for medical equipment manufacturers to ensure their product meet the specific differing standards of the geographic market they are supplying as well as ensuring legacy product are now in line with the new standard. Excelsys Technologies have addressed this by ensuring that all power supplies such as the CoolX, Xsolo, UltiMod and Xgen are certified to both 3rd edition and 4th edition, ensuring that the same power supply will allow medical equipment manufacturers to meet whichever standard is required. Furthermore it greatly simplifies system re-approval of legacy product to the latest regulations, due to the fact that one of the critical components remains unchanged, thereby saving equipment manufacturers a great deal of time and engineering cost.
T
he healthcare industry is changing. There have been major changes in the safety standards that govern medical equipment, with the full adoption of the harmonised standard IEC60601-1 3rd edition, from which national standards are derived (UL, EN, CSA for example). Factors including the increasing age profile of patients, the increase in lifestyle related conditions, as well as the demand for higher levels of healthcare in the developing world has resulted in changes in diagnostics and treatments. The treatment environment is changing with increased levels of outpatient care for many illnesses and treatments including more home care and clinic based activities. We are familiar with the restrictions of use of wirelessly connected devices, (mobile phones, tablets etc.) on aircraft, for example, where they are deemed to pose a risk to equipment sensitive to EMI (Electro-Magnetic Interference). The increasing use of these devices in healthcare environments (home, clinics and hospitals) by patients and clinicians are resulting in changes to the EMC standards that govern medical equipment. In 2014, an update to IEC60101-1-2 was
published and it is commonly referred to as the “4th Edition”. It applies to the basic safety and essential performance of medical equipment and systems in the presence of electromagnetic disturbances
16 MAY 2017 | ELECTRONICS
and to electromagnetic disturbances by that equipment and systems. As a result, product categories were added and increased EMC test levels introduced. The new 4th edition standard defines the electromagnetic environments of intended use. The categories (or intended use environments) are defined as: • Professional Healthcare facilities with medical staff, including surgical centres, functional areas in hospitals, dental surgeries, clinics, intensive care. • Home Healthcare which includes, but is not limited to, dwelling places. It is defined where patients live or can be present (with the exception of Professional Healthcare facilities). This can include hotels, schools, transport. These areas can be subject to much higher levels of interference due to the wide usage of wireless devices in the area. Equipment can be operated by persons with limited or no medical training. • Special Environments. These may be heavy industrial plants or medical treatment areas with high powered medical equipment.
WHEN IS 4TH EDITION REQUIRED? The roll out of IEC60601-1-2 4th Edition will be a requirement in the US in the second quarter of 2017 and is expected to be implemented in Europe in 2018. It will be implemented at different times in
Excelsys CoolX power supplies are certified to the 3rd and 4th editions of IEC60601–1
WHAT TO LOOK OUT FOR Whilst these standards will apply to the medical equipment, component power supplies are not stand alone parts and as such are not required to meet EMI standards from a regulatory perspective. However, switch mode power supplies are active parts in a medical equipment and their EMI characteristics can have a direct impact on the equipment EMI performance. The changes in the 4th edition focus are centred primarily on higher Electro-Static Discharge (ESD) requirements and increased requirements for EMI radiated immunity. Compliance to standards for the medical
industry takes precedence over all other factors. It is incumbent on the equipment supplier to protect patients and operators to the highest level. In order to ensure this, appropriate component selection is paramount. Power supplies certified to the CoolX, UltiMod, Xsolo and Xgen from Excelsys, which are certified to both the 3rd Edition and 4th editions of IEC60601–1, greatly simplify system approval and ensure compliance to the existing and future regulatory iterations of IEC, EN UL and CSA safety standards.
Excelsys Technologies
www.excelsys.com T: +353 21 4354716
/ ELECTRONICS
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