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  • 1.  Usability requirements for specimen receptacles

    This message was posted by a user wishing to remain anonymous
    Posted 01-Jun-2021 08:53
    This message was posted by a user wishing to remain anonymous

    Dear Colleagues,

    Is usability engineering (formative and/or summative evaluation) per IEC 62366 required for specimen receptacles such as blood collection tubes?

    Thank you


  • 2.  RE: Usability requirements for specimen receptacles

    This message was posted by a user wishing to remain anonymous
    Posted 06-Jun-2021 12:21
    This message was posted by a user wishing to remain anonymous

    ​Anon, please clarify. Required by whom?
    Original Message


  • 3.  RE: Usability requirements for specimen receptacles

    This message was posted by a user wishing to remain anonymous
    Posted 10-Jun-2021 08:50
    This message was posted by a user wishing to remain anonymous

    Required by the EU IVD Regulation. There are several references to usability engineering in Annex I of IVDR - Chapter 1 (#1, 3, 5), Chapter 2 (#13.1, 13.2), and Chapter III (#20.1, 20.4.2).
    Original Message


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