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ISO 10993 Biocompatibility Evaluation - Electronic thermometer

#1
Hello guys,

I need your advice regarding to the requirements of Biocompatibility testing on medical devices. Let's assume the device is an electronic thermometer.
According to the ISO 10993 it would be defined as "Intact Skin A." (contact time below 24 hrs), which needs to test for the cytotoxicity, irritation and sensitization.

My question is

Do we really need to use the "final product" for applying the test?
Can we conduct the test by applying the critical contact material?
How do you guys define the "directly contact" to the skin?
Has it included for operating touch? (e.g. hands...)


Thank you.
 

yodon

Staff member
Super Moderator
#2
The reason they want finished product is because often, the manufacturing process can 'alter' the contacted material (e.g., mold release agents, sterilization, etc.).
 
#3
> Do we really need to use the "final product" for applying the test?

ISO 10993-1:2018, section 6.3.2: "Testing shall be performed on the final medical device, or representative samples [...]"

> Can we conduct the test by applying the critical contact material?

See above: if you have a scientifically valid rational, why your "critical" (what do you mean by this term?) contact materials are representative of your final device, then you can proceed with your test set-up of not taking the final device.

> How do you guys define the "directly contact" to the skin?

ISO 10993-1:2018, section 3.6: "medical device (3 .14) or medical device component that comes into physical contact with body tissue" (here: body tissue = intact skin)

> Has it included for operating touch? (e.g. hands...)

Yes, this is a also a kind of body contact.

HTH, Gerhard
 
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