Standard Svensk standard · SS-EN ISO 22870:2016

In vitro-diagnostik - Patientnära analyser - Krav på kvalitet och kompetens (ISO 22870:2016)

Status: Gällande

Omfattning
ISO 22870:2016 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.

Ämnesområden

Kvalitetsledning och kvalitetssäkring (03.120.10) Allmänt Laboratoriemedicin (11.100.01)


Produktinformation

Språk: Engelska

Framtagen av: Laboratoriemedicin, SIS/TK 331

Internationell titel: Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016)

Artikelnummer: STD-8023975

Utgåva: 2

Fastställd: 2016-12-08

Antal sidor: 24

Ersätter: SS-EN ISO 22870:2006