In vitro-diagnostik - Patientnära analyser - Krav på kvalitet och kompetens (ISO 22870:2016)
ISO 22870:2016 gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of this document apply when POCT is carried out in a hospital, clinic and by a healthcare organization providing ambulatory care. This document can be applied to transcutaneous measurements, the analysis of expired air, and in vivo monitoring of physiological parameters.
Patient self-testing in a home or community setting is excluded, but elements of this document can be applicable.
NOTE Local, regional and national regulations are to be taken into consideration.