What is EN ISO 18113-2:2021?

EN ISO 18113-2:2021 is a professional technical standard that provides guidelines and requirements for the design, development, and validation of in vitro diagnostic (IVD) medical devices.

The Scope of EN ISO 18113-2:2021

The standard focuses on IVD devices that are used to perform examinations on human specimens, such as blood, urine, and tissue samples. It covers a wide range of topics, including device specifications, performance characteristics, and quality management systems.

Design and Development Requirements

EN ISO 18113-2:2021 lays out specific requirements for the design and development processes of IVD devices. This includes the identification of user needs, risk management, labeling and instructions for use, and verification and validation activities.

One of the key aspects emphasized in the standard is the need for robust and effective design control. Manufacturers are required to establish and maintain a systematic approach to managing the design and development of their IVD devices, ensuring that they meet the intended purpose while adhering to regulatory and safety requirements.

Validation and Verification

The standard highlights the importance of validation and verification in ensuring the reliability and accuracy of IVD devices. It specifies the necessary steps and procedures to validate and verify the performance characteristics of the devices.

Validation involves confirming that the device performs as intended under real-world conditions, while verification focuses on demonstrating that the device meets its specified requirements. These processes help to minimize the risk of false results and ensure the safety and effectiveness of the devices.

Conclusion

EN ISO 18113-2:2021 is a crucial standard for manufacturers of in vitro diagnostic medical devices. It provides comprehensive guidelines and requirements for the design, development, and validation of these devices, ensuring their safety, accuracy, and reliability. By following this standard, manufacturers can produce high-quality IVD devices that play a critical role in medical diagnosis and patient care.