What is BS EN ISO 18113-2:2016?

BS EN ISO 18113-2:2016 is an international standard that defines the requirements for in vitro diagnostic (IVD) medical devices. This standard specifies the general analytical performance characteristics, such as accuracy, precision, and limits of detection, that IVD devices should meet.

Why is BS EN ISO 18113-2:2016 important?

This standard plays a crucial role in ensuring the reliability and effectiveness of diagnostic tests used in healthcare settings. By providing clear guidelines on performance requirements, it helps manufacturers develop IVD devices that deliver accurate and consistent results, enabling healthcare professionals to make informed decisions regarding patient care.

The key components of BS EN ISO 18113-2:2016

BS EN ISO 18113-2:2016 covers several important aspects of IVD devices. These include:

Accuracy: The ability of a device to provide test results that are close to the true value.

Precision: The agreement between repeated measurements of the same sample.

Sensitivity: The lowest concentration of an analyte that can be reliably detected by the device.

Specificity: The ability to correctly identify the target analyte without interference from other substances.

Linearity: The ability of the device to provide results that are proportional to the concentration of the analyte.

Conclusion

BS EN ISO 18113-2:2016 sets the standards for performance evaluation of IVD devices, ensuring their accuracy, precision, and reliability. By complying with this standard, manufacturers can produce high-quality diagnostics that healthcare professionals trust. This ultimately leads to better patient care, as timely and accurate test results are essential for making informed medical decisions. As technology advances and new diagnostic methods emerge, the relevance of standards like BS EN ISO 18113-2:2016 remains crucial in improving healthcare outcomes.