Any type of medical device that is in direct or indirect contact with the patient's or user's body must be free of risks, including biological and toxicological risks.
The new UNE-EN ISO 10993-17 standard specifies the process and requirements for determining the toxicological risk of components in medical devices.
It also defines the methods and criteria used to determine whether exposure to a component entails any appreciable damage.
The toxicity risk assessment can be a part of the final product's biological assessment, as described in UNE-EN ISO 10993-1:2021.
The process described is applicable to the chemical characterization information obtained by applying UNE-EN ISO 10993-18. This process is necessary when a determination of the toxicological risk is required, since it stems from information on the composition of the product or the chemical analysis data, to determine if the toxicological risks related to the components are insignificant or tolerable.
Both standards, UNE-EN ISO 10993-1 and UNE-EN ISO 10993-18, are essential supplements to the new UNE-EN ISO 10993-17 standard, which references them as essential consultation standards.