What is EN ISO 10993-15:2021?

EN ISO 10993-15:2021, titled "Biological evaluation of medical devices - Part 15: Identification and quantification

of degradation products from metals and alloys", is an international standard that provides guidelines for evaluating the biological safety of medical devices made from metals or alloys. This standard specifies the procedures for identifying and measuring the release of potential toxic substances from these materials when they come into contact with the human body.

Importance of Assessing Degradation Products

Assessing the degradation products of metals and alloys used in medical devices is crucial to ensure their safety and effectiveness. Over time, these materials can deteriorate due to various factors such as corrosion, wear, or chemical reactions within the body. When degradation occurs, potentially harmful substances may be released into the surrounding tissue or bloodstream, which can pose risks to patients.

Testing Methods

EN ISO 10993-15:2021 outlines several testing methods to identify and measure the release of degradation products. These methods include sample preparation, extraction techniques, and analytical procedures. The standard provides guidance on sample collection, storage conditions, and recommended analysis techniques, such as atomic absorption spectrometry, inductively coupled plasma mass spectrometry, or chromatographic methods. These tests help determine the concentration and composition of the released substances and assess their potential toxicity.

Benefits and Applications

Complying with EN ISO 10993-15:2021 ensures that medical device manufacturers evaluate the potential risks associated with degradation products accurately. By identifying and quantifying these substances, appropriate measures can be taken to minimize any adverse effects on patients. This standard is particularly relevant for devices that contain metals or alloys, such as orthopedic implants, cardiovascular stents, or dental prosthetics. Implementing these guidelines contributes to the overall safety and reliability of medical devices in the market.