Scope:
This document 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.
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| Standard number | MS ISO 22870:2016 |
| Title and Sub-titles | Point-of-care testing (POCT) - Requirements for quality and competence |
| Status | Current |
| Replaces | |
| Replaced by | |
| Edition | First |
| Technical Committee | MSB/TC 9 - Conformity Assessment |
| ICS | 03.120.10; 11.100.01 |
| Publication date | 2017/05/06 |
| Corrected version | |
| Government Notice No. | General Notice No.646 of 2017 |
| Number of Pages | 11 |
| Amendments/ Corrigendums | |
| Availability | Yes |
| Note |