Biocompatibility requirement for electrode adapters

subbash

Involved In Discussions
#1
Hi,

We have an ECG cable with Banana type patient end connector. We have been asked to supply tab electrode adapter and adhesive tab electrodes to one of our customer.

"Class II Special Controls Guidance Document: Electrocardiograph Electrode" document mentions about requirements of adhesive electrodes, ECG cables etc. It does not have any details about adapters.

Can you let me know if adapters also need to be biocompatibility certified.

Thanks
 
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planB

Super Moderator
#2
subbash,

in case your adapter has body contact, then yes, your medical-device component will require to be included in a biocompatibility evaluation considering the nature and duration of body exposure. In case your adapter has no body contact, there are no biocompatibility requirements.

HTH,
 
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