According to the standard ISO 10993-1:2009, medical device material characterization as well as related material and chemical testing should be conducted prior to any biocompatibility testing.

Material characterization involves evaluating the suitability of a medical device’s physical and chemical characteristics for its intended use. Furthermore, chemical and physical testing of a device’s materials is necessary for regulatory registration and compliance of many device types.

Relevant standards for medical device material characterization and related testing include:

  • ISO 10993-18:2005 “Biological evaluation of medical devices – Part 18: Chemical characterization of materials” applies to medical device material characterization requirements
  • ISO 10993-9 for identification and qualification of degradation products
  • ISO 10993-12 for sample preparation and reference materials
  • ISO 10993-13 for polymers
  • ISO 10993-14 for ceramics
  • ISO 10993-15 for metals and alloys

Key medical device material and chemical characterization tests

With our expertise, we can help you determine the exact regulatory requirements and types of material characterization and chemical tests for your device.

Such testing usually includes chemical analysis, including tests for chemical composition, evaluations of manufacturing practices that may produce unintended extractable or leachable materials, and tests for performance characteristics like corrosion resistance, permeation rates and shelf life.

After chemical analysis, any degradable or leachable materials identified must undergo toxicological evaluation to determine any risk posed to device users and patients. In addition, your device may require physical evaluation to assess material physical strength, performance characteristic and shelf life.

Ongoing inspections of medical device material characteristics

It is important for medical device manufacturers to keep in mind that even after a device obtains market authorization, some regulators will require ongoing inspections of component materials, in-process controls and final product and packaging inspections.

These inspections help prove that product design changes do not adversely impact biocompatibility. Also, they can help companies show that any new suppliers can meet the same manufacturing requirements as their previous suppliers, or that any retooling of suppliers’ manufacturing capabilities will not affect device materials.

Let us help you with medical device physical and chemical characterization testing

Our testing methods meet ISO 10993 and related requirements, and help manufacturers meet a necessary preliminary step toward full biocompatibility testing. UL physical and chemical materials testing experts utilize multiple modern analytical procedures including GC/MS, HPLC, FTIR, ICP, XPS and SEM/EDX.

Our testing services cover:

  • Material characterization
  • Physiochemical analysis of polymers
  • Metal and ceramic material analysis
  • Residue analysis
  • Toxicological evaluation of degradable and leachable materials

Contact us for more information on material testing and chemical analysis for your medical device.

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