What is EN ISO 10993-17:2009 ?

EN ISO 10993-17:2009 is a critical standard for medical device manufacturers that aims to ensure the safety and effectiveness of their products. This standard, which is divided into two parts, provides guidance on the design and conduct of toxicokinetic studies.

The first part of EN ISO 10993-17:2009, which is titled "Biological evaluation of medical devices - Part 16," provides guidance on the design of toxicokinetic studies for degradation products and leachables. It includes provisions for the planning, conduct, and interpretation of such studies, as well as requirements for the preparation and presentation of the results.

The second part of EN ISO 10993-17:2009, which is titled "Biological evaluation of medical devices - Part 17," provides guidance on the interpretation and evaluation of the results of toxicokinetic studies. It includes provisions for the classification and labeling of degradation products based on their potential toxicity, as well as recommendations for the management and disposal of these products.

The importance of EN ISO 10993-17:2009 for medical device manufacturers cannot be overstated. Compliance with this standard is often a regulatory requirement before medical devices can be marketed or used, and failure to comply with its requirements can result in the suspension or recall of the device.

In conclusion, EN ISO 10993-17:2009 is a crucial standard for medical device manufacturers that aims to ensure the safety and effectiveness of their products. By following the guidelines and requirements outlined in this standard, manufacturers can design medical devices that are safe and effective for use, and minimize the risk of harm or injury to patients.