The International Electrotechnical Commission (IEC) in 2014 published the updated revision of the electromagnetic compatibility (EMC) requirements for medical devices, the IEC 60601-1-2:2014, so called 4th edition, with an effective date of April 1, 2017. This revision makes changes to immunity requirements and the analysis of risk management for electromagnetic disturbances of medical devices, in order to make them safer for use in three intended environmental categories as explained below.
With the roles that power supplies play in medical devices, it is important for Delta to help Design Engineers achieve the most efficient and expeditious way for their designs to meet the 4th edition standard for medical systems and devices. The 3rd edition standard requirements are based on the purpose of the equipment, rather than the environment that it was intended to be used in. The 4th edition standard requirements are broken down into three intended use environmental categories:
Professional Healthcare - Hospitals, clinics, other medical facilities
Home Healthcare - Homes, public spaces
Special Environments - Military installations, industrial zones
These categories more accurately define the operation of medical devices and systems in everyday life, where devices, such as mobile devices or other equipment, may be operating concurrently. Alongside intended use environmental categories, comes new “Intended Use” and “Normal Use” definitions, where:
Intended use is for the intended medical purpose
Normal use is for purposes such as transportation, maintenance, standby
Beyond use within environmental categories, technical changes within 4th edition include:
A) Immunity test level increases: B) Changes to Immunity testing: C) Expansion of Risk Management:
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