MS ISO 22870:2016 Point-of-care testing (POCT) – Requirements for quality and competence

19 Feb

Scope:
This document gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. 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.

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Standard numberMS ISO 22870:2016
Title and Sub-titlesPoint-of-care testing (POCT) - Requirements for quality and competence
StatusCurrent
Replaces
Replaced by
EditionFirst
Technical CommitteeMSB/TC 9 - Conformity Assessment
ICS03.120.10; 11.100.01
Publication date2017/05/06
Corrected version
Government Notice No.General Notice No.646 of 2017
Number of Pages11
Amendments/ Corrigendums
AvailabilityYes
Note