The technical committee for Laboratory Medicine contributes to the development of standards that provides safe and efficient systems, routines within clinical laboratories and safe products for in-vitro diagnostics. The work aims to increase patient safety by developing standards that make diagnoses and analyzes more reliable. The European Standards (ES) are a prerequisite for manufacturers to be able to comply with IVDR 2017/745. The standards also target laboratories in clinical chemistry, clinical microbiology, molecular biology, transfusion medicine and more.
The committee also works with standards for patient centered analysis activities, i.e., all different types of analyzes at pharmacies, clinics and care wards performed by non-laboratory trained staff.
We are happy to announce that our CEO Sofia Nordgren now is a proud member of both the Swedish Institute for Standard’s technical committee 340 (hyperlänk: https://www.sis.se/standardutveckling/tksidor/tk300399/sistk340/ ) and 331 (hyperlänk: https://www.sis.se/standardutveckling/tksidor/tk300399/sistk331/ ) and can continue the work with her fellow committee members to increase patient safety by developing standards that make medical devices, diagnoses and analyzes more reliable.