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ILNAS-EN ISO 22870:2016 Edition 11/2016
Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016)
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  • 25.3 / copy
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Abstract

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.

Status

Standard - Withdrawn

Origin

Technical Committee :
CEN/TC 140 : In vitro diagnostic medical devices

Implementation

start of the vote on the project      date of ratification (dor)    14/10/2016
end of the vote on the project      date of anouncement (doa)    28/02/2017
start of the vote on the final project    21/07/2016   date of publication (dop)    31/05/2017
end of the vote on the final project    13/09/2016   date of withdrawal (dow)    30/11/2019


Publication Official Journal
of the Grand-Duchy of Luxembourg
03/02/2017
Reference Mémorial A N° 146

Relations

Evolutions
ILNAS-EN ISO 15189:2022

Relations to older standards
ILNAS-EN ISO 22870:2006

Relations to international standards
ISO 22870 
ISO 22870:2016 

International Classification for Standards (ICS codes) :

03.120.10 : Quality management and quality assurance
11.100.01 : Laboratory medicine in general

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