This document 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
Patient self-testing in a home or community setting is excluded, but elements of this document can be
NOTE Local, regional and national regulations are to be taken into consideration.