EN ISO 22870:2006

Name: EN ISO 22870:2006
Brand: CEN
SKU: EN ISO 22870:2006
Price: 29.8 EUR
Availability: InStock
Rating: 4 (59 reviews)

Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2006) EN ISO 22870:2006

Publication date: Aug 10, 2006

General information

Current stage: 99.60 Withdrawal effective Nov 30, 2016

Originator: CEN

Owner: CEN/TC 140 In vitro diagnostic medical devices

Type: European Norm

ICS: 03.120.10 Quality management and quality assurance | 11.100 Laboratory medicine

Buying

Status: Withdrawn

Scope

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.

Related legislation

Legislation related to this standard

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

Harmonized/Supporting

NOW

WITHDRAWN
EN ISO 22870:2006
99.60 Withdrawal effective
Nov 30, 2016

REVISED BY

WITHDRAWN
EN ISO 22870:2016