GB/T 21415-2025 Active National standards

GB/T 21415-2025 In vitro diagnostic medical devices—Requirements for establishing metrological traceability of values assigned to calibrators,trueness control materials and human samples

Publish Date: 2025-08-29 Implement Date: 2026-03-01 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 21415-2025

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: -

Publish Date: 2025-08-29

Implement Date: 2026-03-01

Pages: 56 pages

Scope

This document specifies the technical and document requirements necessary for establishing in vitro diagnostic medical device (IVD MD) calibration materials, accuracy control substances, and the traceability of human sample measurement values. Human samples are the samples intended to be measured by each IVD MD. The traceability of human sample measurement values extends to the highest available reference system components, ideally including reference measurement procedures (RMPs) and certified reference materials (CRMs). All parties involved in any step described in the IVD MD calibration hierarchy must comply with the stated requirements, including but not limited to IVD MD manufacturers, RMP developers (see ISO 15193), reference material (RM) producers (see ISO 15194), and reference/calibration laboratories supporting the IVD MD calibration hierarchy (see ISO 15195).