99.60 Withdrawal effective Dec 14, 2022
CEN
CEN/TC 140 In vitro diagnostic medical devices
European Norm
03.120.10 Quality management and quality assurance | 11.100.01 Laboratory medicine in general
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.
Legislation related to this standard
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/Supporting
WITHDRAWN
EN ISO 22870:2006
WITHDRAWN
EN ISO 22870:2016
99.60
Withdrawal effective
Dec 14, 2022
PUBLISHED
EN ISO 15189:2022