New version of EN ISO 10993-1:2008

The ISO 10993 (Biological Evaluation of medical devices) sets out a series of standards for evaluating the biocompatibility of medical devices. Its primary aim is the protection of humans from potential biological risks arising from the use of medical devices and its primary role is to serve as a framework in which to plan a biological evaluation.

Part 1 of this standard is intended to describe the biological evaluation of medical devices within a risk management process, as part of the overall evaluation and development of each medical device. EN ISO 10993-1:2018 has been updated this last August, this fifth edition replaces the previous one, ISO 10993-1:2009. The main changes are found in Annexes A and B:

  • Annex A “Endpoints to be addressed in a biological risk assessment” has been replaced with new columns for “physical and/or chemical information”, “material mediated pyrogenicity”, “chronic toxicity”, “carcinogenicity”, “reproductive/developmental toxicity” and “degradation” which now indicates “endpoints” to be considered with “E” (and not “tests” to be conducted with an “X”).
  • Annex B “Guidance on the risk management process” has been replaced with “Guidance on the conduct of biological evaluation within a risk management process” (formerly ISO TR 15499).

Other changes are significant editing changes throughout the document as well as added information, such as:

  • Additional definitions for terms used throughout the ISO 10993 series of standards.
  • Additional information on the evaluation of “Non-contacting medical devices” and new information on the evaluation of “Transitory-contacting medical devices”.
  • Additional information on the evaluation of nanomaterials and absorbable materials.
  • Additional reference to ISO 18562 for “Biocompatibility evaluation of breathing gas pathways in healthcare applications”.

If you wish to learn more about the new ISO changes and how it can affect your devices, please do not hesitate to contact us. Obelis experts with more than 30 years of experience will gladly assist you!

Claudia Miralles

in News