What is EN ISO 18284:2014 ?

EN ISO 18284:2014 and EN ISO 9447:2014 are both important international standards that play a crucial role in ensuring the quality and accuracy of medical diagnostics.

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 focused on providing 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 consistency and accuracy of test results, as it establishes a reference point that can be used to validate measurements made by different laboratories or testing systems.

EN ISO 9447:2014, on the other hand, is a technical standard that provides guidelines for the preparation and writing of technical documentation for products. It aims to ensure clarity, consistency, and accuracy in technical communication, making it easier for users to understand and use products effectively.

In conclusion, EN ISO 18284:2014 and EN ISO 9447:2014 are both important international standards that help to ensure the quality and accuracy of medical diagnostics. By following the guidelines and requirements set out in these standards, medical professionals can help to improve the consistency and accuracy of test results, ultimately leading to better patient outcomes.