The prospect of correctly testing your custom medical cart can be a daunting task, but it doesn’t have to be difficult. Custom medical cart manufacturers have the insight, knowledge and connections to help you navigate through the testing process.
Does your custom medical cart need to be IEC 60601-1 compliant?
It starts with a simple question: is it a medical device or not? The answer, however, is far from simple, yet custom medical cart manufacturers address it with every new project. Most customers base their answers on whether or not electronics or electricity will be used in contingence with their product. If so, most customers will require it to be compliant and certified.
Leakage current is the main concern with having electronics used in or on a medical cart, especially if it runs the possibility of being near patients with weakened immune systems. These tests ensure that, should a patient touch the cart, it will not emit any stray voltage. For more information on leakage current standards, take a look at this article by the Medical Device & Diagnostic Industry. HUI sends custom medical carts that need testing to a nearby lab, MECA, with whom they have an excellent working relationship.
What will having my medical cart tested mean for me?
Working with a manufacturer who specializes in custom medical carts gives you a huge advantage because they’ll have a baseline for what tests you need and how to design your product with that criteria in mind.
Here’s a list of all the physical IEC 60601-1 tests:
- Durability of markings (7.1.3)
- Stability and Transportability (9.4.2)
- Movement over a threshold (9.4.2.4.3)
- Instability from unwanted lateral movement including sliding (9.4.3.1)
- Instability excluding transport (9.4.3.2)
- Hazards associated with support systems (9.8.2)
- Rough Handling drop test (15.3.5)
- Equipment force for propulsion test (9.4.2.4.2)
Although some manufacturers cannot certify their customer’s equipment, many will conduct these tests in-house to ensure their product passes when it’s submitted to a testing lab.
Medical carts that don’t have power supply or strip built into it might still opt for compliance, but depending on the intended use for the product, some customers reserve the right to forgo those tests and move forward with mindset that their medical cart is more akin to a piece of furniture. However, those that make this choice may need to invest in risk management.
How do I know if my custom medical cart requires risk management?
Risk management discussions come about at the beginning of the FMEA process. If you cannot resolve all the identified issues, and for whatever reason have opted out of the electrical tests, then you will have to collaborate with your regulatory department and initiate risk management.
Every product poses a different scenario, so there’s no one definite way to make this decision or determine what action to take. Obviously, this is something to discuss with your custom medical cart manufacturer, but you will ultimately have to make the choice in the end.
At HUI, we have almost 20 years of experience in guiding customers through this process and helping them find solutions. Contact us today, and we’ll get your project underway.
