DIN EN ISO 22870
Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016)
Organization: | DIN |
Publication Date: | 1 April 2017 |
Status: | active |
Page Count: | 20 |
ICS Code (Quality management and quality assurance): | 03.120.10 |
ICS Code (Laboratory medicine in general): | 11.100.01 |
scope:
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 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.