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
International Organization for Standards (ISO) describes biocompatibility testing in great detail in their well-established guidance ISO 10993: Biological evaluation of medical devices. ISO 10993 is subdivided into twenty parts, with Part 1 defining and describing the applicability of the following parts. ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” is the most recently updated guidance.

EKG has published a longer discussion of ISO 10993 risk analysis and the changing nature of biocompatibility testing which can be accessed here.

ISO 10993 Biocompatibility Testing at EKG Labs

At EKG Labs we specialize in chemical characterization of 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. We are prepared to flag any materials which need further toxicological evaluation or analysis.

EKG is particularly proud of our extractables/leachables program. Our extractables and leachables program is constructed around ISO 10993-12 (sample preparation) and ISO 10993-18 (characterization). We routinely carry out exhaustive extractions (assessed by gravimetric analysis), simulated-use extractions, accelerated aging studies, and leachable studies—all per ISO 10993 guidance. Extraction solutions are typically evaluated, depending on solvent utilized, by LC-MS, GC-MS, and ICP-MS. The end report of an extractable study will list all compounds found and their in-sample concentrations. You can delve into EKG case studies here.

The ISO 10993 parts EKG Labs distinctly assesses are:

  • 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

Please note that EKG Labs does not perform in vivo biological testing.

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