IEC 60601-1 3rd edition’s tests for instability can get confusing unless you’re familiar with the jargon. In some cases the only difference from one test to the next is a key word or phrase that alters the test’s purpose. The following breaks down the nuances found in 60601 tests regarding instability. All medical carts must pass this test regardless of weight or height. If, for whatever reason, your medical cart does not pass this test, then you may want to consider looking into risk management options for rating the safety of your device.
220.127.116.11 Instability in transport position
The first question I’m sure you’re asking is “What is transport position?” Transport position refers to any mobile medical cart or device, which we simulate with a 10° incline. For this test, your medical cart only has to be in normal use. Normal use means your device can be in transport mode—drawers in, doors shut, arms and/or monitors down and so on as stated in your IFU. In order for your medical cart to pass this test, it cannot overbalance while in transport position.
18.104.22.168 Instability excluding transport position
The instability excluding transport position is similar to the previous test. Your medical device cannot overbalance in any normal use position while on a 5° incline. It’s important to note that your custom medical cart absolutely must pass this test at a 5° incline. If, for whatever reason, it does not pass, then your product will need a warning sticker and to go through risk management protocol.
Then the test takes it a bit further and requires you to run the same procedure, except extremities such as doors, drawers and shelves must be placed in the worst positon for stability. Any anticipated weight your device will hold from various devices must be represented in some fashion.
If any of your devices will have equipment filled with liquids, that equipment must be filled, completely, partially or not all—whatever choice presents the most disadvantageous for your medical cart. Good test practice also dictates that whatever floor you use for testing must be hard and flat.
9.4.3 Instability from unwanted lateral movement (including sliding)
This test pertains to medical carts and devices that weigh over 25 kg. If your medical cart is over 25 kg, it must have some kind of braking system to prevent unwanted movement on a 10° incline in transport position. If you’re looking into different braking methods, check out our previous blog on caster choices.
Essentially, the common goal for all of these tests is to ensure the safety of those who will encounter your medical cart, even if that means being in the same room as your product. For instance, the point this particular test is trying to make is that if your cart is heavy enough so it could roll away, gain speed and hurt someone, it must have some kind of braking system.
If you have any further questions regarding IEC 60601-1 3rd Edition’s test for instability or are looking for a custom medical cart manufacturer with experience in that field, feel free to comment below or contact us today. We’re happy to help!