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.
In order to demonstrate safety, this new version of the standard now emphasises risk analysis by selecting adequate tests as well as toxicological risk assessment by using materials testing. 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 generally 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