Medical Device Chemical Characterization Services

The development of medical devices is guided by ISO 10993, a series of internationally harmonized standards for evaluating medical device biocompatibility to assess and manage biological risk. In meeting these standards, medical device manufactures must now ensure that their analytical laboratory is conducting chemical characterization studies in alignment with the requirements of ISO 10993.

Chemical characterization studies are designed based on the overall complexity of the medical device to identify the types and amounts of chemical entities, known as extractables and leachables, that may impart a biological risk to patients when used in a clinical setting. Common testing modalities in characterizing extractables and leachables include, but is not limited to, Fourier Transform Infrared Spectroscopy (FTIR) to determine initial organic chemical analysis, Mass Spectrometry (MS) for detailed chemical structural analysis, Inductively Coupled Plasma Mass Spectrometry (ICP-MS) to detect trace and heavy metals, and Gas Chromatography (GC) for evaluation of volatile chemicals.

In 2020,  the ISO 10993‑18 (Chemical Characterization of Medical Device Materials within a Risk Management Process) standard was updated to formalize the use of the Analytical Evaluation Threshold (AET) in chemical characterization studies. AET is a defined threshold at or above which the analytical laboratory should identify and report a particular extractable and/or leachable to facilitate assessment of the toxicological risk of the device. Implementation and use of the AET is intended to harmonize chemical characterization and subsequent toxicological risk assessment across the medical device manufacturing industry.

Pacific BioLabs was prepared for the 2020 revisions to the ISO 10993-18 standard that have since been successfully integrated into its comprehensive Biocompatibility Program. Consequently, Pacific BioLabs is well positioned to support chemical characterization and safety assessment of Client medical devices in compliance with regulatory guidelines.

Available Methods

  • FTIR testing for Non Volatile Residues or Extracts
  • Exhaustive Extraction
  • GC-MS test for Volatile and Semi Volatile Organic Extracts
  • ICP-MS test for Inorganic and Heavy Metals Extracts
  • LC-MS test for Non Volatile Organic Extracts
  • UV-Vis Spectrophotometry to Evaluate Colorant
  • Instrumentation Details

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