The new ISO 10993-18: 2020 Medical Devices biological evaluation – Part 18: Medical Devices materials chemical characterization as part of a risk management process standard has been published.
The standard is a reference regulatory framework aimed at guiding a biological assessment that minimizes the number and the exposure of animals to the test.
The standard promotes chemical-physical properties evaluation and tests performed with in vitro models within risk assessment process.
Characterization procedure and the correspondent flow diagram are founded on ISO 10993-1 standard principles, in particular, as it is considered more efficient and effective the risk evaluation process that presents the minimum quantity of the chemical information needed to declare that a medical device presents an acceptable health risk.
The specifics that establish the presence of a detailed collection of physical and chemical information on the device or medical component are relevant in the ISO 10993-1 standard.
Furthermore it is provided the identification and the materials quantification, if needed, of which the Medical Devices are formed of.
The device composition must be suitable for the purpose regarding the material characteristics and properties that can include chemical, toxicological, physical substances, electrical, morphological, mechanical properties.
ISO 10993:2018 is applicable when the material or the medical device has a direct or indirect contact with the patient’s body.