What is EN ISO 18284:2014

EN ISO 18284:2014, also known as the In vitro Diagnostic Medical Devices - Measurement of quantities in samples of biological origin - Metrological traceability of values assigned to calibrators and control materials standard, is an important international standard in the field of medical diagnostics.

The Purpose of EN ISO 18284:2014

This standard provides guidelines for ensuring metrological traceability in relation to values assigned to calibrators and control materials used in in vitro diagnostic medical devices. Metrological traceability is crucial for ensuring the accuracy and comparability of test results, as it establishes a reference point that can be used to validate measurements made by different laboratories or testing systems.

Key Components of EN ISO 18284:2014

EN ISO 18284:2014 lays out the requirements for establishing metrological traceability in the field of medical diagnostics. It covers various aspects of the measurement process, including the selection and use of calibrators and control materials, the assignment of values to these materials, and the validation of measurement results. The standard also provides guidance on the documentation and reporting of traceability information, which is essential for ensuring the transparency and reliability of test results.

Benefits and Impact of EN ISO 18284:2014

The implementation of EN ISO 18284:2014 has several benefits for both manufacturers of in vitro diagnostic medical devices and healthcare professionals. By following the guidelines set forth in this standard, manufacturers can ensure that their products meet the necessary quality and performance requirements. Healthcare professionals can rely on the traceability information provided by diagnostic tests to make accurate diagnoses and treatment decisions, leading to improved patient outcomes. Additionally, the standard promotes harmonization and mutual recognition of test results, facilitating international cooperation and trade in the field of medical diagnostics.