EN ISO 22870:2016

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

Publication date:   Jan 18, 2017

General information

99.60 Withdrawal effective   Dec 14, 2022

CEN

CEN/TC 140 In vitro diagnostic medical devices

European Norm

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

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Scope

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.

Related legislation

Legislation related to this standard

765/2008

REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93

Harmonized/Supporting

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 22870:2006

NOW

WITHDRAWN
EN ISO 22870:2016
99.60 Withdrawal effective
Dec 14, 2022

REVISED BY

PUBLISHED
EN ISO 15189:2022