What is EN ISO 18113-2:2021?

EN ISO 18113-2:2021 is a technical standard that provides guidelines for the development and validation of in vitro diagnostic (IVD) medical devices. It focuses specifically on the requirements for procedures used in the examination of specimens derived from the human body, such as blood, urine, and tissue samples.

The Importance of EN ISO 18113-2:2021

Compliance with EN ISO 18113-2:2021 is crucial for manufacturers of IVD medical devices, as it ensures their products meet regulatory and quality standards. By following this standard, manufacturers can enhance the accuracy and reliability of their diagnostic tests, ultimately leading to improved patient outcomes and safety.

EN ISO 18113-2:2021 covers various aspects of IVD medical devices, including design control, risk management, and performance evaluation. Adhering to these guidelines enables manufacturers to demonstrate product performance, effectively manage risks, and promote continuous improvement.

The Key Elements of EN ISO 18113-2:2021

EN ISO 18113-2:2021 incorporates several essential elements that manufacturers must consider during the development and validation of IVD medical devices:

1. Test System Description: This section outlines the intended use, principle of operation, and components of the test system. It provides a clear understanding of how the device works and the purpose it serves within the diagnostic process.

2. Performance Characteristics: Manufacturers need to define and evaluate various parameters related to the performance of the test system. This includes accuracy, precision, analytical sensitivity, and limit of detection, among others. By assessing these characteristics, manufacturers can ensure reliable and consistent test results.

3. User Interface: EN ISO 18113-2:2021 emphasizes the importance of a user-friendly interface that enables healthcare professionals to perform the test correctly and interpret the results accurately. This includes clear instructions, intuitive operation, and unambiguous result reporting.

4. Analytical Validation: The standard requires manufacturers to validate the analytical performance of their IVD devices through rigorous testing. This involves verifying the device's performance across different specimen types, ensuring consistent results in various laboratory conditions.

In Summary

EN ISO 18113-2:2021 plays a vital role in ensuring the quality, reliability, and safety of in vitro diagnostic medical devices. By following this standard, manufacturers can develop high-quality products that meet regulatory requirements and contribute to improved patient care.