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Guidance for supervisors and operators of point-of-care testing (POCT) devices
Scope of Application:
This document provides guidance for supervisors and operators performing point-of-care testing (POCT) services without medical laboratory training, supervision, or support, including key considerations for providing safe and reliable POCT results.
This document does not cover self-testing products.
Basic information
Standard No:GB/Z 43281-2023
Standard Name: 即时检验(POCT)设备监督员和操作员指南
English Name:Guidance for supervisors and operators of point-of-care testing (POCT) devices
Standard Status:In force
Release Date:2023-11-27
Effective Date:2024-06-01
Language of Publication:Simplified Chinese
Publication Information
Number of pages:32
Number of words:60 K
Other Information
Technical Committees:National Technical Committee for Standardization of Clinical Laboratory Testing and In Vitro Diagnostic Systems (SAC/TC 136)
Proposed Unit:National Medical Products Administration
Application Dept:State Administration for Market Supervision and Administration, State Standardization Administration