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Language: English

ISO 15190: Medical laboratories — Requirements for safety

[ISO 15190]

This document specifies requirements for safe practices in the medical laboratory.


The International Organization for Standardization (ISO) 15190: Medical laboratories — Requirements for safety outlines specific requirements for safe practices in medical laboratories.  The Standards specify requirements for setting the roles and responsibilities of a laboratory safety officer, who in turn is in charge of making sure employees are empowered to take personal responsibility over the safety of themselves and others in the laboratory. The first edition was published in 2003, and the second and most current edition was published in 2020.

ISO 15190 was developed by the ISO technical committee 212: Clinical laboratory testing and in vitro diagnostic test systems, which was composed of global experts from the field. ISO 15190 is part of the ISO 11.100.01: Laboratory Medicine in General set of standards, which contains other laboratory standards, such as ISO 15189: Medical laboratories — Requirements for quality and competence. ISO also links this document with Sustainable Development Goal 3: Good Health and Well Being. The Standard is available for purchase through ISO, and is published in English. The ISO is an independent, non-governmental association of 166 national standards bodies from around the world. Each of their members helps contribute to creating international standards across many fields and then aids in disseminating and implementing the standards in their own countries.