2. TOXICOLOGICAL RISK ASSESSMENT
Calculation of safety margins based on toxicity and concentration of identified extractables
TOXICOLOGICAL RISK ASSESSMENT (TRA)
Calculation of safety margins based on toxicity and concentration of identified extractables
WHAT IS THE TOXICOLOGICAL RISK ASSESSMENT FOR MEDICAL DEVICES?
A toxicological risk assessment is a comprehensive safety assessment of a device, based on its composition, the materials used and taking into account the intended use. The detailed scientific report on the toxicological assessment contains all available and relevant information and data on a specific ingredient in relation to the medical device under investigation. This includes the dosage, the concentration and the specific exposure scenario.
The toxicological risk assessment is a scientific evaluation and includes the following activities:
Characterization of substances that can be extracted and leached
Evaluation of exposure
Dose-response assessment
Identification of hazards and evaluation of data
Risk characterization
WHY IS TOXICOLOGICAL RISK ASSESSMENT SO IMPORTANT FOR THE SAFETY OF MEDICAL DEVICES?
Properly evaluating and assessing the biological and toxicological risks, posed by extractables or chemical residues that may impact patient safety, is one of the more challenging aspects of the chemical characterization process.
To control the risk associated with extractable substances, these substances are identified, the related risks are quantified and exposure to these substances is limited so that acceptable limits are not exceeded.
RISK MANAGEMENT?
Risk assessment is an important and essential part of the chemical characterization and biocompatibility testing, since it defines the acceptable limits for extractable and leachable substances.
The ISO 10993 standard series serves as a framework for assessing the biocompatibility of medical devices and the management of biological risks. The specific standards ISO 10993-17 and ISO/TS 21726 regulate the evaluation criteria for the toxicological risk analysis of the components of medical devices and the determination of the acceptable limit values for extractable substances.
