What is BS EN ISO 10993-24:2011+A1:2018?

In the field of medical devices, the safety and biocompatibility of materials used are of utmost importance. One crucial standard that ensures the evaluation of biological safety for devices is BS EN ISO 10993-24:2011+A1:2018. This technical article aims to provide an of this standard and its significance in the medical device industry.

The Scope of BS EN ISO 10993-24:2011+A1:2018

BS EN ISO 10993-24:2011+A1:2018 specifically focuses on the assessment of tissue irritation resulting from contact with medical device materials. It provides guidelines for evaluating potential adverse effects caused by these materials when they come into direct or indirect contact with human tissues or cells. The standard helps identify the potential risks associated with these materials and plays a crucial role in ensuring the safety of medical devices.

Evaluation Methods

The standard outlines various methods for evaluating tissue irritation. These methods include in vitro tests and in vivo tests, depending on the nature of the material and the intended use of the medical device. In vitro tests involve examining the interaction between the material and specific cell lines to assess cellular toxicity. On the other hand, in vivo tests require the implantation or application of the material on animal models to evaluate tissue reactions accurately. The standard provides detailed guidance on test design, endpoints, and interpretation of results to ensure consistent and reliable evaluations.

The Importance of Compliance

Compliance with BS EN ISO 10993-24:2011+A1:2018 is essential for medical device manufacturers. Adherence to this standard helps ensure patient safety, as it enables early identification of potential risks associated with medical device materials. By conducting thorough evaluations following the guidelines outlined in the standard, manufacturers can make informed decisions regarding material selection and mitigate any potential adverse effects caused by tissue irritation. Compliance also demonstrates the commitment of manufacturers towards quality and safety, instilling confidence among healthcare professionals and patients alike.