Biocompatibility for Medical Devices

  • What is Medical Device Biocompatibility?

    According to the FDA, biocompatibility “is the ability of a device material to perform with an appropriate host response in a specific situation”. (Source: FDA Use of International Standard ISO-10993-1) For practical discussion, this means that the materials that make up a medical device, which are intended for contact with, or in, the human body, should not have a negative impact on a patient’s health. It is possible that once a device comes into contact with the body that some of the materials, or their degradants, leachables or residuals could have a deleterious impact on the patient. In order to better understand a medical device’s health risks, the FDA has issued guidance entitled ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”. This guidance includes recommendations for the chemical characterization of medical device materials and when analytical testing may be needed.

  • Biocompatibility for Medical Devices
Medical Device Biocompatibility Services at EKG Labs

At EKG Labs we specialize in characterizing medical device materials to provide biocompatibility data for regulatory filings. We have experience working with a variety of materials including polymers, metals, ceramics and composites. In addition to these raw materials, we understand how to characterize ancillary chemicals associated with device production such plasticizers, fillers, additives, cleaning agents and release agents. EKG Labs also has experience with novel drug-device combination products like drug eluting stents. We have a thorough understanding of ISO 10993-1 and related ISO standards including:

  • Part 1: Evaluation and testing in the risk management process
  • Part 7: Ethylene oxide sterilization residuals
  • Part 9: Framework for identification and quantification of potential degradation products
  • Part 12: Sample preparation and reference materials
  • Part 13: Identification and quantification of degradation products from polymeric medical devices
  • Part 14: Identification and quantification of degradation products from ceramics
  • Part 15: Identification and quantification of degradation products from metals and alloys
  • Part 18: Chemical characterization of materials
Medical Device Biocompatibility Analytical Techniques
  • Chromatographic Characterization – HPLC, LC/MS, GC, GC/MS, GC/FID, GC/TCD, GPC/SEC
  • Spectroscopy Characterization – ICP-MS, NMR, MS, PXRD, TF-XRD, UV-Vis, FTIR, Raman
  • Microscopy – SEM, TEM, AFM, STM, LSCM
  • Other- TGA, DSC, TOC, BET Surface Area/Pore Size Analyzer