1. International Organization for Standardization. ISO 17511 - In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples. 2nd ed. Geneva: ISO; 2020.
2. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and;Commission Decision,2010
3. Clinical and Laboratory Standards Institute. EP12-A3 Evaluation of qualitative, binary output examination performance. 3rd ed. Bethesda (MA): CLSI; 2023.
4. Bureau International des Poids et Mesures. International vocabulary of metrology - Basic and general concepts and associated terms (VIM), 2008 version with minor corrections. 3rd ed.: BIPM; 2012.
5. Bureau International des Poids et Mesures. International Vocabulary of Metrology - Committee Draft (VIM4 CD). 4th ed.: BIPM; 2021.