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Clarification regarding tests in IEC 60601-2-25

Discussion in 'Medical Devices (21 CFR Part 820)' started by subbash, Aug 8, 2018.

  1. subbash

    subbash New Member

    Aug 8, 2018
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    I am new to testing the ECG device as per IEC 60601-2-25 standard. I want to test a battery operated ECG device, which can work in 6 lead or 12 lead mode.

    I have gone through the IEC60601-2-25 document and have few aspects that needs clarification.

    1. In the indication of Inoperable ECG test. The standard says that when the saturation point is reached, we need to check that the amplitude of the signal (10 Hz, 1 mV) that is fed is reduced to less than 0.5 mV.

    Clarification required: Observing the reduction in amplitude when saturation point is reached is it the only requirement or do we need to have any indicator.

    2. On the ECG report we are only printing Heart rate, RR,PR interval, QRS, QT/QTc duration, QRS Axis. But there are some tests which require measurements related to amplitude and ST segment details. The standard does not mention if we have to print on the ECG record.

    Clarification required: If we have to print the details on the report.

    3. Recovery Time test: Is this test applicable to an ECG device which have a lead switch function only..?

    Request you to provide me some suggestions and share your experience in qualifying the ECG device as per IEC60601-2-25 standard

    Please also share your experience about the testing device if you have used such as Whaleteq's SECG, MECG, CMRR devices.

    Thanks and Regards,
    Last edited by a moderator: Aug 8, 2018