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SSH EN ISO 22870:2016

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

Mar 28, 2017

General information

60.60     Jan 16, 2017

DPS

DPS/KT 140

European Norm

11.100.01     03.120.10  

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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 directives

Directives related to this standards.

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
Directive 765/2008

Life cycle

PREVIOUSLY

PUBLISHED
SSH EN ISO 22870:2016

NOW

PUBLISHED
SSH EN ISO 22870:2016
60.60 Standard published
Jan 16, 2017

REVISED BY

PUBLISHED
SSH EN ISO 22870:2016

Related project

Adopted from EN ISO 22870:2016

Adopted from ISO 22870:2016