Actual Definition of Non-Contact for ISO 10993

D

dwayneq

#1
I have a device which is handheld and attached to a desktop control unit by way of an interconnect cable. The patient contact device is being tested for short term skin contact as well as the portion held by the clinical user with the standard skin contact procedure lasting about one hour. The question has come up regarding the same biocompatibility requirements being required of the interconnect cable jacket since it could possibly come in skin contact with the user as they move the device or accidently touch the patient during positioning. I believe that this falls under the term "non-intended" contact and thus only needs to show that the interconnect jacket is non-toxic. I have tested cable jackets before but usually because the intended use would mean the cable likely would lie on the patient for a good portion of the procedure. Can anyone help with some good direction?
 
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