Using Components not intended for Medical Devices

B

Bruce Banner

#1
An interesting point came up today, when sourcing components.
Many suppliers tend to state that their components are not intended for use in a medical device.
I am assuming they state this as cover themselves from liability. Does it make it ok to use these components when the finished good has been verified and validated and tested?
 
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yodon

Staff member
Super Moderator
#2
Too many questions (in my mind) to be able to answer that. The biggest of which is what you mean by verified, validated, and tested. If the component is, say, a battery charger that you plug into AC and it's not "medical grade" then it may not pass Safety (e.g., UL / ETL) testing (but may pass your internal testing). If the component measures something and it's not intended for medical devices because accuracy isn't guaranteed then, again, it may pass your testing but may not be appropriate.

Maybe more info on what the components are, why the mfg believes they aren't suitable for use in a medical device, what has been done for "verified and validated and tested," etc. would allow for a better discussion.
 

somashekar

Staff member
Super Moderator
#3
Does it make it ok to use these components when the finished good has been verified and validated and tested?
As a designer, one is required to study the component characteristics, determine suitability for your application and decide to use. Further you have the performance and safety tests that need to be undertaken for various product evaluation which also involves third party test approvals and authorization to apply safety mark.
There is the burn-in which each of the product undergo, before final testing and gets authorization to ship.
Many suppliers tend to state that their components are not intended for use in a medical device.
Perhaps this is driven by the user's question about use in medical devices more specifically.
As the performance and reliability is of atmost importance in medical devices, a manufacturer of components surely does not state it is intended for medical devices, but takes all possible steps to ensure the performance and reliability, and the decision is purely left to the designer of the medical device. Going further no manufacturer states that the component is intended for entertainment electronic products or industrial electronic application or such. A list of typical applications would be mentioned for designers convenience. With regard to use in medical devices, it is more of a disclaimer statement.
 
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