EN ISO 22870:2016
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016)
30-11-2019
30-11-2016
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Management requirements
5 Technical requirements
Bibliography
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.
| Committee |
CEN/TC 140
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Standards | Relationship |
| ISO 22870:2016 | Identical |
| DIN EN ISO 22870:2016-08 (Draft) | Identical |
| NF EN ISO 22870 : 2017 | Identical |
| SN EN ISO 22870:2017 | Identical |
| NBN EN ISO 22870 : 2006 | Identical |
| PN EN ISO 22870 : 2017 | Identical |
| NEN EN ISO 22870 : 2016 | Identical |
| NS EN ISO 22870 : 2016 | Identical |
| BS EN ISO 22870:2016 | Identical |
| SS-EN ISO 22870 : 2016 | Identical |
| UNI EN ISO 22870 : 2017 | Identical |
| UNI EN ISO 22870 : 2006 | Identical |
| I.S. EN ISO 22870:2016 | Identical |
| UNE-EN ISO 22870:2017 | Identical |
| DIN EN ISO 22870:2017-04 | Identical |
| DIN EN ISO 22870:2006-06 | Identical |
| ISO 15189:2012 | Medical laboratories — Requirements for quality and competence |
| ISO 18113-4:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing |
| ISO/IEC 17043:2010 | Conformity assessment — General requirements for proficiency testing |
| EN 13532:2002 | General requirements for in vitro diagnostic medical devices for self-testing |
| ISO 18113-5:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing |
| CLSI POCT7 A : 1ED 2010 | QUALITY MANAGEMENT: APPROACHES TO REDUCING ERRORS AT THE POINT OF CARE |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.