ISO 10993 Testing Services

Pace Analytical Life Sciences (PLS) provides testing services for evaluating the biocompatibility of a medical device prior to a clinical study. The testing services that we provide support the following ISO 10993 standards:

  • ISO 10993-3, In vitro genotoxicity tests
  • ISO 10993-4, In vitro hemocompatability tests
  • ISO 10993-5, Tests for In vitro Cytotoxicity
  • ISO 10993 – 7, Ethylene Oxide Sterilization Residuals
  • ISO 10993 –13, Identification and quantification of degradation products from polymeric medical devices
  • ISO 10993 – 15, Identification and quantification of degradation products from metals and alloys
  • ISO 10993 – 18, Material characterization

The ISO 10993 testing services that we provide aid in the biological evaluation of medical devices. These testing services are performed to determine the potential toxicity resulting from contact of the component materials of the device with the body. When selecting the appropriate tests for biological evaluation of a medical device, one must consider the chemical characteristics of device materials and the nature, degree, frequency and duration of its exposure to the body.

Experts in the Field

Our technical experts are actively participating in industry and preparing for the future testing needs of our clients. Our experts are attending technical meetings, participating in discussions, and offering presentations to peers and colleagues in a range of settings. We are carefully watching the progress of currently proposed changes to the ISO 10993 evaluation recommendations and preparing our service offerings to support the future needs of customers.

Pace Analytical Life Sciences is FDA registered, DEA registered, cGMP compliant, and ISO/IEC 17025 accredited.

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Evaluation of Medical Devices