RSS icon

Sterilization and Biocompatibility Q&A

  •   Do you need to perform a biocompatibility assessment on a non-patient-contacting device—for instance, sterile interface cables used in conjuction with electrophysiology catheters?

    Answered July 27th, 2011 by Expert: Dr. Jerry Nelson

    According to the ISO 10993 standard, you should perform biocompatibility testing only on material that directly or indirectly contacts the patient. Thus, if the material does not contact the patient, testing is not necessary.

    .