EN ISO 22870:2016
Withdrawn
Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016)
11-30-2016
11-30-2019
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Withdrawn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 |
| 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 |
| I.S. EN ISO 22870:2016 | Identical |
| DIN EN ISO 22870:2017-04 | Identical |
| DIN EN ISO 22870:2006-06 | Identical |
| UNE-EN ISO 22870:2017 | Identical |
| ECA EA-4/20 G:2021 | Guidance for the assessment of laboratories against EN ISO 15189 and EN ISO 22870 Point-of Care Testing (POCT) |
| 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 |