IS0 10993 - 2018 Review Of Updates
IS0 10993-1 updated to include emphasis on chemical assessment.
ISO 10993-1:2018 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process, has now been published.
The new version of the standard moves the emphasis further towards using risk analysis to select the required tests and using materials testing with toxicological risk assessment as the preferred route for demonstrating safety. Added to the risk analysis is consideration of device deterioration over time or breakage exposing normally masked materials.
A revised test matrix now lists chemical (and physical) analysis as the first column of testing for all classes of device, as well as all periods and levels of invasiveness of contact. MET has developed an analysis programme offering five different levels of chemical analysis according to patient contact. This is consistent with the ISO 10993 ‘endpoints in biological risk assessment’ matrix. Specific chemical analysis may not be required for low risk devices, if sufficient information is available on the component materials.
There is also a new category of ‘transient contact’. This category general only needs to be tested if the device has significant re-use or could leave traces of material behind.
Medical Device Biocompatibility Testing and ISO 10993-18 Studies