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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 , PDF 3 Users , PDF 5 Users , PDF 9 Users
06-12-2022
English, French
26-10-2016
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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.
| DevelopmentNote |
Supersedes ISO/DIS 22870. (10/2016)
|
| DocumentType |
Standard
|
| Pages |
11
|
| PublisherName |
International Organization for Standardization
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| Status |
Superseded
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NF EN ISO 22870 : 2017 | Identical |
| NEN EN ISO 22870 : 2016 | Identical |
| NS EN ISO 22870 : 2016 | Identical |
| I.S. EN ISO 22870:2016 | Identical |
| PN EN ISO 22870 : 2017 | Identical |
| SN EN ISO 22870:2017 | Identical |
| UNI EN ISO 22870 : 2006 | Identical |
| SS-EN ISO 22870 : 2016 | Identical |
| UNI EN ISO 22870 : 2017 | Identical |
| BS EN ISO 22870:2016 | Identical |
| EN ISO 22870:2016 | Identical |
| DIN EN ISO 22870:2016-08 (Draft) | Identical |
| IS 17723 : 2021 | Identical |
| UNE-EN ISO 22870:2017 | Identical |
| DIN EN ISO 22870:2006-06 | Identical |
| GOST R ISO 22870 : 2009 | Identical |
| BIS IS/ISO 15189 : 2012 | MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE |
| ISO 16142-2:2017 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| I.S. EN ISO 15189:2012 | MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE (ISO 15189:2012, CORRECTED VERSION 2014-08-15) |
| ANSI/AAMI/ISO 16142-2:2017 | MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| ECA ILAC G26 : 2012 | GUIDANCE FOR THE IMPLEMENTATION OF A MEDICAL LABORATORY ACCREDITATION SYSTEM |
| UNE-EN ISO 15189:2013 | Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15) |
| BS ISO 16142-2:2017 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| DIN EN ISO 15189:2014-11 | Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15) |
| UNI EN ISO 15189 : 2013 | MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE |
| ISO 15189:2012 | Medical laboratories — Requirements for quality and competence |
| BS EN ISO 15189:2012 | Medical laboratories. Requirements for quality and competence |
| 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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