Guide to ISO 10993-1:2018 Published by MET
Medical Engineering Technologies (MET) has published a guide to ISO 10993-1:2018. The article ‘The mysteries of the 2018/2019 edition of biocompatibility standard ISO 10993’ appears in Medical Plastic News.
Under the new part 1 standard, all medical devices need a Biological Evaluation Plan as part of the risk management process. MET provides comprehensive support in building up this plan, risk assessing, and establishing the safety of your device. This extends from the initial examination of the device and input materials, through chemical analysis and material characterisation, to the Toxicological Risk Analysis and your Biological Evaluation Report.
A guide to the application of the new standard is available from chemical characterisation white paper. It explains the new importance of material and chemical characterisation. For more invasive products the biocompatibility end points can be addressed much more quickly and at lower cost than through biological testing.
Don’t forget that these matters need to be addressed for MDR compliance.
We work on medical device biocompatibility every day, so that you don’t need to!