Good day Anon,
I doubt you will find anything specific citing specimen receptacles such as blood collection tubes requiring usability testing. Recommend you approach this from a risk management perspective because usability and risk management are directly related to each other. An actual study may not be necessary if the risk management supports the hazards, risk analysis, risk assessment, and residual risks are all under "control" such as from the EU MDR - the risks do not outweigh the benefits of use. For some devices, these are well known, used for many years, risk profile established, so a usability study may not be performed through justification. Unfortunately sometimes the amount of effort to justify this to a reviewer might be the same or more than just doing a small summative study. There is not just a sentence or even paragraph which can be written in a technical document somewhere, now we need to look at hazards, risks, benefits, information to user, market data, etc. Just be prepared to answer the question because it is certainly valid and question being asked more and more today especially in Europe for CE Marking.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 28-May-2021 15:29
From: Anonymous Member
Subject: Usability requirements for specimen receptacles
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