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Which ISO 60601 sub standard is applicable to ECG portable monitor?

Discussion in 'IEC 60601 - Medical Electrical Equipment Safety' started by divyagan, Jul 31, 2015.

  1. divyagan

    divyagan New Member

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    ECG portable monitor needs to be tested for ISO 60601 standard. kindly let me know which are the substandard needs to be tested..
    Thank you
     
  2. Ronen E

    Ronen E Well-Known Member

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  3. Pads38

    Pads38 Member

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    There are several of the sub-standards that may apply to an ECG monitor.

    60601-2-25 Specification for electrocardiographs
    60601-2-27 elctrocardiographic monitoring equipment (as identified by Ronen)
    60601-2-49 multifunction patient monitoring equipment
    60601-2-51 recording and analysing electrocardiographs

    To decide which of these is most appropriate find them in the IEC webstore (Ronen's link) and use the "Preview" button to have a look at the first few pages of each standard. That will include the "Scope" of the standard from which the applicability of each standard may be ascertained.

    To add to the Part 2 Particular standard you will also need:-

    60601-1 General
    60601-1-2 EMC
    60601-1-6 / 62366 Usability
    60601-1-8 Alarms
    60601-1-11 Equipment for use in a home healthcare environment (if applicable)
    60601-1-12 Equipment intended for use in the emergency medical services environment (ambulances etc) (if applicable)
     
    Ronen E and Atul Khandekar like this.

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