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ILNAS-EN ISO 22870:2006 Edition 02/2006
Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2006)
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  • 21.2 / copy
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Abstract

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.

Status

Standard - Superseded

Origin

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

Directives

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

Implementation

start of the vote on the project    13/07/2004   date of ratification (dor)    23/01/2006
end of the vote on the project    13/12/2004   date of anouncement (doa)    31/05/2006
start of the vote on the final project    20/10/2005   date of publication (dop)    31/08/2006
end of the vote on the final project    20/12/2005   date of withdrawal (dow)    31/08/2006


Publication Official Journal
of the Grand-Duchy of Luxembourg
31/03/2006
Reference

Relations

Evolutions
ILNAS-EN ISO 22870:2016

Relations to international standards
ISO 22870 
ISO 22870:2006 

International Classification for Standards (ICS codes) :

03.120.10 : Quality management and quality assurance
11.100 : Laboratory medicine

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