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BS EN ISO 22870:2016

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Point-of-care testing (POCT). Requirements for quality and competence

Available format(s)

Hardcopy , PDF

Superseded date

16-12-2022

Language(s)

English

Published date

31-12-2016

€156.59
Excluding VAT

Committee
CH/212
DevelopmentNote
Supersedes 04/30090846 DC. (04/2006)
DocumentType
Standard
Pages
22
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

This document gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO15189. 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.

NOTE Local, regional and national regulations are to be taken into consideration.

ISO 15189:2012 Medical laboratories — Requirements for quality and competence
ISO 18113-4:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
ISO/IEC 17043:2010 Conformity assessment — General requirements for proficiency testing
EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
ISO 18113-5:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
CLSI POCT7 A : 1ED 2010 QUALITY MANAGEMENT: APPROACHES TO REDUCING ERRORS AT THE POINT OF CARE

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