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  • 1.  Portable equipment & IEC 60601-1

    This message was posted by a user wishing to remain anonymous
    Posted 03-Sep-2019 11:22
    This message was posted by a user wishing to remain anonymous

    I am tripping up on the definition for portable equipment - particularly on the phrase 'once installed and placed into service' when applied to a bench-top device without a battery backup. As such, this device wouldn't function whilst being moved, so I think this does not fit with the definition? 

    Portable
    term referring to TRANSPORTABLE equipment that, once installed and placed into service, is intended to be moved from one location to another while being carried by one or more persons.

    Transportable
    term referring to equipment that, once installed and placed into service, is intended to be moved from one place to another whether or not connected to a supply and without an appreciable restriction of range.

    If portable is the wrong term to use, is there another term I should be using? IEC 60601-1 lists terms including: portable, handheld, transportable, permanently installed, but none of these appear to apply. If there isn't a term, how do I make this clear this clear to an auditor/test-house within documentation such as the device description?


  • 2.  RE: Portable equipment & IEC 60601-1

    Posted 04-Sep-2019 03:40
    Once installed and placed into service is in all the definitions of equipment types you mention. PORTABLE, TRANSPORTABLE, FIXED, etc.  Note, all small caps words in the standard are defined terms.  'Once installed and placed into service' just means the medical device is in it's intended location of use basically and ready for use.  Your device can be PORTABLE and not have to operate while being moved.  The only time the device really has to operate when moving around is when used in a BODY-WORN usage case.

    You may want to also look at the figure in Annex A, figure A.20 (under sub-clause 3.63) and the text just prior to that that states: "This standard applies several terms to describe ME EQUIPMENT, ACCESSORIES and ME EQUIPMENT parts. They are FIXED (3.30), STATIONARY (3.118), TRANSPORTABLE (3.130), MOBILE (3.65), PORTABLE (3.85), HAND-HELD (3.37) and BODY-WORN (3.144). To help in understanding the relationship of these terms, the chart in Figure A.20 was developed."

    Below is the figure for reference only.


    ------------------------------
    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------

    Original Message


  • 3.  RE: Portable equipment & IEC 60601-1

    This message was posted by a user wishing to remain anonymous
    Posted 04-Sep-2019 09:54
    This message was posted by a user wishing to remain anonymous

    That's much clearer, thank you Leo. I checked all the defined terms, including 3.63 medical electrical equipment but didn't check that one for a sub-clause!
    I have to keep a notepad to hand with all the internal cross-references in IEC 60601-1, I'm hoping the next edition might have hyperlinks.
    Original Message


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