BAS EN ISO 22870:2012
Point-of-care testing (POCT) - Requirements for quality and competence
General Information
Status: Withdrawn
No. of pages: 14
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 08.06.2012
Technical committee:
Directive:
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;
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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.
Lifecycle
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Original document and degree of correspondence
- EN ISO 22870:2006, identical
- ISO 22870:2006, identical