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EN ISO 22870:2006

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

Publication date:   Aug 10, 2006

General information

99.60 Withdrawal effective   Nov 30, 2016

CEN

CEN/TC 140 In vitro diagnostic medical devices

European Norm

03.120.10   Quality management and quality assurance | 11.100   Laboratory medicine

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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 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
Legislation 765/2008

Life cycle

NOW

WITHDRAWN
EN ISO 22870:2006
99.60 Withdrawal effective
Nov 30, 2016

REVISED BY

WITHDRAWN
EN ISO 22870:2016