ISO 10993 Biocompatibility for Medical Devices and Combination Products

  • What is 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) Put more simply, this means the materials (or their degradants, leachables, or residuals) that make up a medical device which is intended for contact with or in the human body should not have a negative impact on a patient’s health. This can include delivery systems and combination products.

  • scientist gently inserting needle with hand
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 describes when analytical testing may be needed. In many ways these investigations are similar to extractable and leachable studies.

EKG Labs has a thorough understanding of ISO 10993 standards including:

  • ISO 10993-1: Evaluation and testing in the risk management process
  • ISO 10993-7: Ethylene oxide sterilization residuals
  • ISO 10993-9: Framework for identification and quantification of potential degradation products
  • ISO 10993-12: Sample preparation and reference materials
  • ISO 10993-13: Identification and quantification of degradation products from polymeric medical devices
  • ISO 10993-14: Identification and quantification of degradation products from ceramics
  • ISO 10993-15: Identification and quantification of degradation products from metals and alloys
  • ISO 10993-18: Chemical characterization of materials
ISO 10993 Biocompatibility Testing at EKG Labs

At EKG Labs we specialize in characterizing medical device materials to provide ISO 10993 biocompatibility data for regulatory filings. Our team has years of experience working with diverse pharmaceutical products and a variety of medical device 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 as plasticizers, fillers, additives, cleaning agents, and release agents. EKG regularly carries out exhaustive extractions, simulated use extractions, leachable studies, and accelerated aging studies. We are prepared to flag any materials which need further toxicological evaluation or analysis.

EKG Labs further supports medical device and combination drug device analysis by offering regulatory consulting services to help you navigate the complex FDA regulatory process.

Combination Product Biocompatibility at EKG Labs

The drug component of combination products and devices adds additional chemical variables to the medical profile which need evaluation. These drug/device combinations are among the most challenging products to submit to the FDA for review. As such, they require extensive forethought and planning for testing and analysis. EKG Labs leverages its knowledge of extractables, leachables, and biocompatibility to help companies develop combination products and devices for FDA approval. We have experience with many novel medical device and drug-device combination products like drug-eluting stents, bioabsorbable implants, and intraocular lenses.

Learn more about our combination product and device experience.

EKG Labs Analytical Techniques
  • Chromatographic Characterization – HPLC, LC/MS, 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
  • Learn more about our instrumentation here