Withdrawn
ISO 22870:2016 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.
NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.
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
WITHDRAWN
SRPS EN ISO 22870:2017
95.99
Withdrawal of Standard
Mar 30, 2023
PUBLISHED
SRPS EN ISO 15189:2023