BS EN ISO 22870:2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Point-of-care testing (POCT). Requirements for quality and competence
Hardcopy , PDF
English
31-12-2016
06-12-2023
| Committee |
CH/212
|
| DevelopmentNote |
Supersedes 04/30090846 DC. (04/2006)
|
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
This document gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO15189. 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.
NOTE Local, regional and national regulations are to be taken into consideration.
| 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 |
| NEN EN ISO 22870 : 2016 | Identical |
| NS EN ISO 22870 : 2016 | Identical |
| EN ISO 22870:2016 | Identical |
| I.S. EN ISO 22870:2016 | Identical |
| DIN EN ISO 22870:2006-06 | Identical |
| UNE-EN ISO 22870:2017 | 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 |
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