Materials Characterization: ISO 10993 Part 18

In accordance with final guidance from ISO 10993 in 2016, materials characterizations should be considered for every device. Extractable/leachable studies are conducted to get a full characterization of all chemicals, which is then used to create an accurate assessment of risk. WuXi AppTec Laboratory Testing Division Medical Device Platform is the leader in complete identification—to us, unknowns are unacceptable. Let our team design a chemistry program tailored to meet your analytical needs.

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  • AA
  • HPLC-DAD and RI, size exclusion
  • HS-GC-MS
  • Direct Inject GCMS
  • IC
  • DSC
  • TGA
  • Microscope FTIR
  • Dynamic Light Scattering
  • Particle Count
  • Spectrophotometer

ISO 10993 Part 18

Designing an extractables/leachables study for your device requires an understanding of the materials and manufacturing process. Even commonly used materials can have different extractables/leachables results based on impurities and processing. Our team of chemists and toxicologists will meet with customers to develop an appropriate test plan that aligns with current regulatory expectations.

Analytical equipment commonly used for extractables and leachables studies includes:

  • Inductively Coupled Plasma-Mass Spectrometry to identify elements and metals
  • Gas Chromatography-Mass Spectrometry and Headspace Gas Chromatography-Mass Spectrometry to identify volatile and semi-volatile compounds
  • Liquid Chromatography-Mass Spectrometry to identify semi-volatile compounds to non-volatile compounds

Multiple analytical techniques aid in uncovering the full range of extracted chemicals associated with your product. Regulatory bodies are looking for this as part of the assessment of risk associated with your product.

Full identification of the chemicals is required, and unknowns must be treated as worst-case scenarios. WuXi Medical Device Platform is the industry leader in identification, and our chemistry program was built knowing that chemistry data alone—without a toxicological risk assessment—is not enough to support product safety.