EN ISO 22870:2006

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

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.

Patientennahe Untersuchungen (point-of-care testing, POCT) - Anforderungen an Qualität und Kompetenz (ISO 22870:2006)

Diese Internationale Norm legt besondere Anforderungen fest, die für patientennahe Untersuchungen gelten, und ist zur Anwendung im Zusammenhang mit ISO 15189 vorgesehen. Die Anforderungen dieser Internationalen Norm gelten, wenn POCT in einem Krankenhaus oder einer Klinik erfolgen, und dürfen auch in einer Pflegeorganisation angewendet werden, die ambulante Patientenversorgung durchführt. Sie kann für transkutane Messungen, die Analyse der Ausatemluft und die In vivo Überwachung physiologischer Parameter angewendet werden.
Die Selbstuntersuchung von Patienten in deren Heim oder in einer Gemeinschaftseinrichtung fällt nicht unter diese Internationale Norm, aber bestimmte ihrer Elemente können dafür gelten.
ANMERKUNG    Örtliche, regionale und nationale Bestimmungen sind zu berücksichtigen.

Analyses de biologie délocalisées (ADBD) - Exigences concernant la qualité et la compétence (ISO 22870:2006)

L'ISO 22870:2006 fournit des exigences spécifiques des analyses de biologie délocalisées et est destinée à être utilisée conjointement à l'ISO 15189. Les exigences de l'ISO 22870:2006 s'appliquent lorsque les ADBD sont réalisées dans un hôpital ou une clinique et par un organisme de santé prodiguant des soins ambulatoires. Elle peut s'appliquer à des mesurages transcutanés, à l'analyse de l'air expiré et à la surveillance in vivo de paramètres physiologiques.
L'auto-test par les patients à domicile ou dans un dispensaire est exclu, mais certains éléments de l'ISO 22870:2006 peuvent s'appliquer.

Preskušanje ob preiskovancu (POCT) – Zahteve za kakovost in usposobljenost (ISO 22870:2006)

General Information

• Status: Withdrawn
• Publication Date: 31-Jan-2006
• Withdrawal Date: 29-Nov-2016
• ICS: 03.120.10 - Quality management and quality assurance
• ICS: 11.100 - Laboratory medicine
• Technical Committee: CEN/TC 140 - In vitro diagnostic systems
• Drafting Committee: CEN/TC 140 - In vitro diagnostic systems
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 30-Nov-2016
• Directive: 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
• Mandate: M/417 - Standardisation mandate addessed to CEN, CENELEC, and ETSI for the use of Harmonised Standards in support of the new legal framework and sectoral certification schemes
• Ref Project: SIST EN ISO 22870:2006 - Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2006)

Relations

• Replaced By: EN ISO 22870:2016 - Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Preskušanje ob preiskovancu (POCT) – Zahteve za kakovost in usposobljenost (ISO 22870:2006)Patientennahe Untersuchungen (point-of-care testing, POCT) - Anforderungen an Qualität und Kompetenz (ISO 22870:2006)Analyses de biologie délocalisées (ADBD) - Exigences concernant la qualité et la compétence (ISO 22870:2006)Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2006)11.100.01Laboratorijska medicina na splošnoLaboratory medicine in general03.120.10Vodenje in zagotavljanje kakovostiQuality management and quality assuranceICS:Ta slovenski standard je istoveten z:EN ISO 22870:2006SIST EN ISO 22870:2006en01-april-2006SIST EN ISO 22870:2006SLOVENSKI
STANDARD



SIST EN ISO 22870:2006



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 22870
February 2006 ICS 03.120.10; 11.100.01 English Version
Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2006)
Analyses de biologie délocalisées (ADBD) - Exigences concernant la qualité et la compétence (ISO 22870:2006) Patientennahe Untersuchungen (point-of-care testing, POCT) - Anforderungen an Qualität und Kompetenz (ISO 22870:2006) This European Standard was approved by CEN on 23 January 2006.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36
B-1050 Brussels © 2006 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 22870:2006: ESIST EN ISO 22870:2006



EN ISO 22870:2006 (E)
2
Foreword
This document (EN ISO 22870:2006) has been prepared by Technical Committee ISO/TC 212 "Clinical laboratory testing and in vitro diagnostic test systems" in collaboration with Technical Committee CEN/TC 140 "In vitro diagnostic medical devices", the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by August 2006, and conflicting national standards shall be withdrawn at the latest by August 2006.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 22870:2006 has been approved by CEN as EN ISO 22870:2006 without any modifications.
SIST EN ISO 22870:2006



Reference numberISO 22870:2006(E)© ISO 2006
INTERNATIONAL STANDARD ISO22870First edition2006-02-01Point-of-care testing (POCT) — Requirements for quality and competenceAnalyses de biologie délocalisées (ADBD) — Exigences concernant la qualité et la compétence
SIST EN ISO 22870:2006



ISO 22870:2006(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
©
ISO 2006 Al
...