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.
NOTE Local, regional, and national regulations are to be taken into consideration.
Diese ÖNORM enthält Anforderungen an labormedizinische Untersuchungen direkt am Patienten, wie z.B. transkutane Messungen, Analyse der Ausatemluft, Beobachtungen von physiologischen Parametern.