What is BS EN ISO 10993-16:2017?

BS EN ISO 10993-16:2017, also known as BS EN ISO 10993-16:2017, is a standard that provides guidelines for the biological evaluation of medical devices. It specifically focuses on the testing of devices that come into direct or indirect contact with the human skin. This standard is an essential tool for manufacturers, regulators, and other stakeholders in ensuring the safety and effectiveness of medical devices.

The Importance of Biological Evaluation

Biological evaluation plays a crucial role in the development and assessment of medical devices. The potential risks associated with the use of these devices need to be thoroughly investigated to ensure patient safety. BS EN ISO 10993-16:2017 outlines a systematic approach to evaluating the biological risks by considering various factors such as material characterization, exposure duration, and intended clinical use.

Key Elements of BS EN ISO 10993-16:2017

This standard covers several key elements that need to be considered during the biological evaluation process. Firstly, it emphasizes the importance of understanding the chemical composition and physical properties of the device materials. This includes the identification of extractable substances that may interact with the human body. The standard also highlights the need to assess the potential for irritation, sensitization, and cytotoxicity.

Furthermore, BS EN ISO 10993-16:2017 recognizes the significance of conducting comprehensive testing to evaluate any potential systemic toxicity and genotoxicity. It provides guidance on assessing the device's effects on hemocompatibility, including blood coagulation and complement activation. Additionally, this standard addresses considerations related to the testing of antimicrobial devices and biodegradable materials.

Application of BS EN ISO 10993-16:2017

The application of BS EN ISO 10993-16:2017 is essential for manufacturers when bringing new medical devices to market. It enables them to demonstrate compliance with regulatory requirements and ensures patient safety. Regulatory bodies, such as the FDA in the United States and the European Commission, often require adherence to this standard during the approval process. Moreover, healthcare professionals can rely on the results of biological evaluation to assist in device selection and improve patient outcomes.