ISO 22870:2016

ISO 22870:2006 gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of ISO 22870:2006 apply when POCT is carried out in hospital, clinic and by a healthcare organization providing ambulatory care. It 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 ISO 22870:2006 can be applicable.

This document specifies requirements for quality and competence in medical laboratories. This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies. This document is also applicable to point-of-care testing (POCT). NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.