Updates in ISO 10993-17:2023 Unveiled
The International Organization for Standardization (ISO) has recently released a new standard titled ISO 10993-17:2023, focusing on the toxicological risk assessment of medical devices. This update aims to provide comprehensive guidance on evaluating the potential risks posed by medical devices, ensuring patient safety.
ISO 10993, a series of standards dedicated to the biological evaluation of medical devices, has been updated to reflect current scientific understanding and regulatory requirements. The new standard is significant as it offers more detailed instructions on the toxicological risk evaluation process, particularly concerning the chemical characterization of medical devices.
The risk estimation in ISO 10993-17:2023 is based on three key criteria: Tolerable intake (TI) or contact level, Worst-case estimated exposure dose (EED), and Margin of safety (MOS). These criteria help in determining the potential risks associated with the use of medical devices.
The updated standard does not repeat the criteria for the risk estimation or the terminology changes previously implemented in ISO 10993-17. However, it does introduce several new terms, such as Exposure dose, Carcinogen, Constituents, Dose-response, Harmful dose, Human carcinogen, and Margin of safety.
A crucial aspect of the updated standard is the emphasis on the definition of hazards, which focuses on the elements that potentially cause harm relevant to exposure situations. This emphasis underscores the importance of thorough material characterization in risk assessment.
The updated FDA guidance suggests that biocompatibility evaluations should be conducted within the framework of a risk management process. This means that once risks have been identified, the sponsor should assess what information is already available regarding those risks and identify the knowledge gaps. A plan should then be developed to address these gaps either through biocompatibility testing or other evaluations that appropriately address the risks.
The updated ISO 10993-17:2023 also offers more comprehensive guidance about when a toxicological risk assessment of a medical device is advised. This includes situations where the likelihood of health harm should be addressed by other means.
For manufacturers seeking FDA pre-market approval, compliance with relevant standards and regulations, including providing thorough risk assessments like toxicological evaluations, is crucial. These updates in ISO 10993-17:2023 are a significant step towards ensuring the safety and effectiveness of medical devices for patients.
For specific details on the changes in ISO 10993-17:2023, it would be best to consult the official ISO documentation or attend industry events where such updates are discussed. Events like the North American Biocompatibility Summit provide platforms for discussing regulatory updates and the latest strategies in biocompatibility assessment, making them valuable for staying updated on the evolving landscape of medical device safety and compliance.
- Since the International Organization for Standardization (ISO) has launched ISO 10993-17:2023, it is essential for medical device manufacturers to conform with this new standard in their bio-evaluation processes.
- The updated version of ISO 10993-17:2023 provides guidance on the risk assessment of medical devices, particularly focusing on the chemical characterization of these devices in relation to health-and-wellness and medical-conditions.
- In addition to offering comprehensive instructions on the toxicological risk evaluation process, the updated ISO 10993-17:2023 also introduces new terms like Dose-response, Harmful dose, and Margin of safety to be useful in the science of medical devices and health-and-wellness.
