In recent years, the medical power supply safety standard about EMC has undergone historic changes to EMC: IEC60601-1-2 4.1.
EMC: IEC60601-1-2: 2014 (ED 4.0) was issued by the International Electrotechnical Commission (IEC) on February 25, 2014 and became effective on April 1, 2017. In 2018, Europe, the United States and Canada adopted the fourth edition of 60601 -1 electromagnetic compatibility (EMC). In other countries/regions, there are previous versions of medical safety standards, but they will gradually adopt EMC: IEC60601-1-2 (ED 4.0).
*Professional healthcare-hospitals, clinics and other medical facilities
*Home health care-houses, nursing homes for the elderly and other public places
*Special environment-the operation of medical systems and equipment in military facilities and industrial areas under these conditions; including mobile equipment and other equipment are divided into:
**Intended use is for the intended medical purpose
**Normal use is for transportation, maintenance, standby and other purposes
Except for use in environmental categories, the changes of IEC60601-1-2: 2014 EMC Fourth Edition are as follows:
1) Improve the level of immune testing:
*The test range of radiated immunity is up to 2.7GHz (2.5GHz in the third edition)
*The anti-electromagnetic interference capability is 30A/m
* Conducted immunity at 6V in ISM band
* ESD under 8kV contact and 15kV air (the third edition is 6kV and 8kV respectively)
2) Changes in immune test:
*Immunity test level conforms to IEC 60601-1-11
*Immunity testing now follows the same port-by-port convention as the IEC 61000-6 series of general EMC standards
2) Expand risk management:
*The manufacturer must submit the test plan and risk analysis documents before testing
*The operation mode is based on risk analysis.
*Electromagnetic interference should be reasonably foreseen during the risk management process.
*The risk management process determines whether subsystem testing is allowed.
Though the EN version has been published and estimate to become mandatory in the EU in three years, the FDA recognized the latest IEC 60601-1-2:2014 + A1:2020 standard at the end of 2020. Let’s follow what happen next closely.
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