This standard specifies the requirements for reference measurement procedures used in vitro diagnostic medical devices. It outlines the criteria necessary to ensure that these procedures are reliable and accurate, thereby supporting the proper functioning of diagnostic equipment. The document addresses various aspects such as documentation, validation methods, analytical performance evaluation, and user information. These provisions aim to facilitate the development, implementation, and use of reference measurement procedures for in vitro diagnostics.
*** Please note: This description may not be accurate, please refer to the official documentation.