GB/T 44672-2024 Active National standards

GB/T 44672-2024 In vitro diagnostic medical devices—Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples

Publish Date: 2024-09-29 Implement Date: 2025-04-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: GB/T 44672-2024

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: -

Publish Date: 2024-09-29

Implement Date: 2025-04-01

Pages: 24 pages

Scope

This document specifies the requirements for a consistency program implemented by an international organization. The program is aimed at achieving equivalence of the measured values of the same target in two or more IVD MD results when there are no reference measurement procedures, no applicable certified reference materials, or no internationally agreed calibration products. In this case, the consistency program defines the maximum level of metrological traceability for the specified measured target.
This document is applicable to situations where certified reference materials or internationally agreed calibration products exist, but are not suitable for use due to factors such as incompatibility with human samples.