Last August, the 2018 version of the ISO 10993-1 Standard “Biological evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process” was published.
The new version includes some significant changes:
a) revision of Annex A “Endpoints to be addressed in a biological risk assessment”. While Table A1 in the previous version of the Standard was often used by manufacturers as a simple checklist for biological tests to be performed during the biological evaluation process, the 2018 version focuses on additional aspects of biocompatibility (toxicological endpoints: material mediated pyrogenicity, chronic toxicity, carcinogenicity, reproductive/developmental toxicity and degradation), previously described in the text of the Standard, and now included in the aforementioned Table A1.
Furthermore, while the physical and/or chemical information has been added as necessary pre-requisites for the biological risk assessment (indicated with X in Table A1), all the other toxicological endpoints must be evaluated case by case, based on the available data set (indicated with E in Table A1).
b) replacement of Annex B “Guidance on the risk management process” with “Guidance on the conduct of biological evaluation within a risk management process” (ISO/TR 15499: 2016);
c) additional terms and definitions;
d) additional information on the evaluation of non-contacting Medical Devices, transitory-contacting Medical Devices, nanomaterials, and absorbable materials;
e) added reference to ISO 18562 “Biocompatibility evaluation of breathing gas pathways in healthcare applications” for respiratory devices.
The new version cancels and replaces ISO 10993-1:2009 and incorporates the ISO 10993-1:2009/Cor.1:2010 technical correction.
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