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Medical EMC: IEC60601-1-2:2014 (ED 4.0)

In recent years, there is historic change on the safety standard for medical power supplies, EMC: IEC60601-1-2:2014 (ED 4.0).

Astek medical switching power supplies leads into IEC60601-1-2:2014 EMC 4th version. If you are interested in, please inquire us info@astekglobe.com.

EMC: IEC60601-1-2:2014 (ED 4.0) was published by The International Electrotechnical Commission (IEC) on Feb. 25 of 2014, effected on Apr. 1 of 2017. In 2018, Euro, America and Canada adopted 4th edition 60601-1 Electromagnetic Compatibility (EMC). In the other countries, the previous versions of medical safety standards existed, however, they will adopt EMC: IEC60601-1-2 (ED 4.0) gradually.

With time changes, EMC shall consider three categories of environments for medical devices:

*Professional Healthcare - Hospitals, clinics, and the other medical facilities

*Home Healthcare - Homes, Elderly Nursing Home and another public places

*Special Environments - Military installations, industrial zones

Under these conditions, the operation of medical systems and devices; including mobile devices and another equipment are divided into:

*Intended use is for the intended medical purpose

*Normal use is for purposes, like transportation, maintenance, standby

Except the use under environmental categories, the changes of EMC 4th edition of IEC60601-1-2:2014 are as below,

1) Immunity test level increases:

*The testing range for radiated immunity harmonized up to 2.7GHz (up from 2.5GHz in 3rd edition)

*Magnetic immunity at 30A/m

*Conducted immunity at 6V in ISM bands

*ESD at 8kV contact and 15kV air (up from 6kV and 8kV respectively in 3rd edition)

2) Changes to Immunity testing:

*Immunity test levels are harmonized with IEC 60601-1-11

*Immunity testing now follows the same port-by-port convention of the IEC 61000-6 series of Generic EMC standards

2) Expansion of Risk Management:

*Manufacturers have to submit a test plan and the risk analysis document before testing

*Operating modes are based on risk analysis.

*Reasonably foreseeable electromagnetic disturbances shall be in the risk management process.

*The risk management process determines if subsystem testing is allowed or not.

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