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SRPS EN ISO 22870:2013

Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2006)

Feb 28, 2013
95.99   Withdrawal of Standard   Jan 30, 2015

General information

95.99     Jan 30, 2015

ISS

Z076

European Norm

03.120.10     11.100     11.100.01  

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Scope

ISO 22870:2006 gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of ISO 22870:2006 apply when POCT is carried out in hospital, clinic and by a healthcare organization providing ambulatory care. It 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 ISO 22870:2006 can be applicable.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

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

NOW

WITHDRAWN
SRPS EN ISO 22870:2013
95.99 Withdrawal of Standard
Jan 30, 2015

REVISED BY

WITHDRAWN
SRPS EN ISO 22870:2017

WITHDRAWN
SRPS EN ISO 22870:2015

Related project

Adopted from EN ISO 22870:2006

Adopted from ISO 22870:2006 IDENTICAL