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What's New for Medical EMC?

posted Sep 12, 2017, 10:48 AM by Unknown user   [ updated Sep 12, 2017, 12:02 PM ]

Amendment underway to the Electromagnetic Disturbances standard

Early 2017, work began on Amendment 1 to IEC 60601-1-2:2014, edition 4.0, the medical electrical equipment collateral standard for electromagnetic disturbances.  With Amendment 1, the edition will become 4.1 and target publication date will be late 2019.

 The "Short List" items for the electromagnetic disturbances standard are summarized below:

·        Perform conducted and radiated emissions testing using multiple AC input voltages

·        Clarification of voltage dips and Interrupts to with respect to the min./max voltage rating

·        Delete the exemption for testing short SIP/SOP cables for conducted immunity testing

·        Consider the use of IEC 61000-4-39 for Close Field Proximity testing

·        Clarify the emissions requirements for devices used on aircraft

·        Simplify Annex E (Special Environments)

·        Simplify Annex F (Risk Management)

·        Add a low frequency (<150 kHz) magnetic Immunity test requirement

·        Update references to CISPR standards

·        Correct an error for the voltage dips and interrupts testing (Table 5 note r) as it contradicts similar note in Table 1


The Kobe agreement (Nov 2015) and voting in Frankfurt (Oct 2016) by the TC62 National Committees established a “Short List” of safety critical issues, which will be addressed in the next amendments to the IEC 60601 general standard and all of the collateral standards.

Darryl Ray a member of IEC TC 62, SC 62A Maintenance Team 23, the committee responsible for this work, can be contacted for further questions. 

Darryl, together with OBCM, is offering along with Safety Training an EMC Training Seminar in Boston, November 2017.  

For more details click here.