Hello Anon,
Further information would be needed, but a medical cart, as an electronic or active product, might not even be considered a medical device. If the cart is only providing electrical power and helping to organise other devices, again it might not even be considered a medical device. If connected to multiple devices, this also may depend on what classification of devices are being connected because it might take on the parent device classification. As a default it might be considered Class I under Rule 12, although there are many other items or considerations to make.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 06-May-2024 13:08
From: Anonymous Member
Subject: Risk classification - Cart equipped with electrical components
This message was posted by a user wishing to remain anonymous
Hi,
Any feedback would be appreciated as to whether a medical cart equipped with electrical components (e.g. power supply) to supply power to multiple devices would be classified as a class I or class II devices in Canada. What would be the classification rule used to dictate the risk class ?
Thanks in advance.