EN ISO 22870:2016

Name: EN ISO 22870:2016
Brand: CEN

Withdrawn

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

Withdrawn date

11-30-2019

Published date

11-30-2016

Publisher

Comite Europeen de Normalisation

European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Management requirements
5 Technical requirements
Bibliography

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.

DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Withdrawn

Standards	Relationship
ISO 22870:2016	Identical
DIN EN ISO 22870:2016-08 (Draft)	Identical
NF EN ISO 22870 : 2017	Identical
SN EN ISO 22870:2017	Identical
NBN EN ISO 22870 : 2006	Identical
PN EN ISO 22870 : 2017	Identical
NEN EN ISO 22870 : 2016	Identical
NS EN ISO 22870 : 2016	Identical
BS EN ISO 22870:2016	Identical
SS-EN ISO 22870 : 2016	Identical
UNI EN ISO 22870 : 2017	Identical
UNI EN ISO 22870 : 2006	Identical
I.S. EN ISO 22870:2016	Identical
UNE-EN ISO 22870:2017	Identical
DIN EN ISO 22870:2017-04	Identical
DIN EN ISO 22870:2006-06	Identical

ISO 15189:2012	Medical laboratories — Requirements for quality and competence
ISO 18113-4:2009	In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
ISO/IEC 17043:2010	Conformity assessment — General requirements for proficiency testing
EN 13532:2002	General requirements for in vitro diagnostic medical devices for self-testing
ISO 18113-5:2009	In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
CLSI POCT7 A : 1ED 2010	QUALITY MANAGEMENT: APPROACHES TO REDUCING ERRORS AT THE POINT OF CARE