The ISO 10993-17 standard has been revised and a new edition was finally released in September this year. With a new title, new scope and new statements added on its applicability, the standard now clarifies when toxicological risk assessment is needed, how to calculate worst-case estimated exposure dose and when the probability of occurrence of harm to health should be addressed by other means.
A toxicological risk assessment is a part of the overall biological evaluation process for the majority of medical devices, as described in ISO 10993-1. This new standard outlines a method and criteria to assess whether exposure to an identified chemical constituent or impurity is without appreciable harm to health.
Why do we need this standard? A medical device or material that has direct or indirect contact with the patient or user is expected to perform its intended use while being free from unacceptable risk, including biological and toxicological risks. For this reason, medical devices are typically subjected to a biological evaluation to assess their biocompatibility. The ISO 10993-series emphasizes how chemical characterization can be used to refine the biocompatibility test plan and reduce the need for other tests. Physical and chemical characterization shall precede any biological testing, as the most efficient and effective approach. The process described in the new revised part 17 applies to chemical characterization information obtained in line with ISO 10993-18.
In this free webinar we will present the changes adopted in the new revised standard ISO 10993-17 and explain how to use the described new methods and tools when evaluating toxicological risks.
