TS EN ISO 22870

TS EN ISO 22870 addresses requirements for quality and competence in point-of-care testing (POCT). It is positioned for use together with ISO 15189, helping healthcare organizations understand how rapid tests performed away from the central laboratory, or closely linked to it, are governed and controlled.

The clinical setting and the quality framework for POCT

POCT refers to testing performed near the patient, with results available quickly enough to support immediate clinical decisions. In that setting, speed is only one part of performance; reliable results also depend on trained operators, suitable devices, sample handling, quality control, documentation, and clear assignment of responsibility. This standard is aimed at that operational environment and applies when POCT is carried out in hospitals, clinics, and healthcare organizations providing ambulatory care.

Measurement types brought into scope

The document states that it can be applied to transcutaneous measurements, analysis of expired air, and in vivo monitoring of physiological parameters. These are technically distinct from conventional laboratory tests: skin-based measurements, breath analysis, and continuous physiological monitoring each place different demands on device use, operator competence, and result interpretation. In general technical terms, POCT standardization exists to balance rapid turnaround with disciplined quality practices.

This TSE record is based on the 2016 EN/ISO edition and is withdrawn. It should therefore be treated as an archival technical reference rather than a current active standard, while still being useful for understanding the quality-management and competence concepts associated with POCT.