ISO 10993-1 requires that devices which contact the body indirectly – by means of a fluid or gas passed through the device and into the patient – must be assessed for biological safety. Doing this for things like blood bags and infusion sets has been well understood for decades, but what about ventilators and other respiratory devices. Here the mechanisms for transport of contaminants from the device to the patient via an inhaled gas have been less well understood, and the interpretation of ISO 10993 has been obscure to say the least.
Enter ISO 18562. This new series of standards essentially provide a worked example of applicaiton of ISO 10993 in practice for gas pathways. These new standards provide detailed guidance on assessment of such devices, including on the methods for testing and evaluation of biological safety and applicaiton of risk assessment following the approach of other ISO standards , particulalry ISO 10993-17 on allowable limits.
And now US FDA has recognised the UISO 18562 suite (with some specific exceptions to certain clauses). To read more see this detailed white paper Biocompatibility of Breathing Gas Pathways from Senior Consultant James Morrison. James is a materials scientist and toxicologist with more than a decade in practice of biological evaluation of medical devices. He is the current Head of the Australian technical Delegation to ISO for development of biocompatibility standards and was closely involved in preparation of the ISO 18562 series.
Biocompatibility Services from Brandwood Biomedical We can provide detailed technical and regulatory advisory services, including advice on materials selection and evaluation, preparation of technical risk assessments and regulatory submissions and reviews. We can support design and implementation of biological evaluation test programs including selection of appropriate test laboratories and working directly with the laboratory to ensure protocols are optimised for your regulatory purposes. Need help with biocompatibility? Contact us directly today. Email firstname.lastname@example.org or call our Sydney office on +61 2 9906 2984 or toll-free USA: 1-888-271-5063 or China: 400-842 7017.