I.S. EN ISO 22870:2016
Current
The latest, up-to-date edition.
POINT-OF-CARE TESTING (POCT) - REQUIREMENTS FOR QUALITY AND COMPETENCE (ISO 22870:2016)
Hardcopy , PDF
English
01-01-2016
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Management requirements
5 Technical requirements
Bibliography
Provides specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189.
| DocumentType |
Standard
|
| Pages |
28
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| SN EN ISO 22870:2017 | Identical |
| NBN EN ISO 22870 : 2006 | Identical |
| NEN EN ISO 22870 : 2016 | Identical |
| NS EN ISO 22870 : 2016 | Identical |
| BS EN ISO 22870:2016 | Identical |
| EN ISO 22870:2016 | Identical |
| UNI EN ISO 22870 : 2006 | Identical |
| ISO 22870:2016 | Identical |
| DIN EN ISO 22870:2016-08 (Draft) | Identical |
| NF EN ISO 22870 : 2017 | Identical |
| UNE-EN ISO 22870:2017 | 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 |
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