This International Standard gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of this International Standard apply when POCT is carried out in hospital, clinic and by a healthcare organization providing ambulatory care. This International Standard 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 International Standard can be applicable.