For medical devices with direct or indirect patient contact, the biological safety of the device considering its intended use should be considered. Typically, biocompatibility evaluation studies are performed, where necessary, in accordance to ISO 10993-1:2009 “Biological evaluation of medical devices – Part 1: Evaluation and testing”. With regard to an US FDA registration of the device further tests may be necessary as specified in the FDA guidance document “Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”, issued on June 16, 2016. Both documents classify medical devices regarding their nature of body contact and contact duration and lists the biological test methods applicable for the respective device category. However, the tables showing the applicable biological test methods should not be used as a check box. The biological tests can be divided into in vitro and in vivo tests.

However, before starting several biological tests ISO 10993-1 requests to carry out extensive physicochemical analyses in order to identify and quantify at least leachable substances to be expected during regular intended use. Such tests are performed under the umbrella of the material characterization as described in ISO 10993-18:2005 (see page “Physical and Chemical Testing“)

What we do:

  • Cytotoxicity Testing
  • Tests for Sensitization
  • Tests for Irritation and Intracutaneous Reactivity
  • Systemic Toxicity
  • Genotoxicity Testing
  • Implantation Tests
  • USP Biological Reactivity Tests
  • Hemocompatibility Testing
  • Pyrogen Testing

Contact us for a free proposal on testing related to ISO 10993.