JJF 2155-2024 Active National Metrology Technical Specifications JJF

JJF 2155-2024 Evaluation Requirement for Commutability of Reference Materials in Laboratory Medicine

JJF 2155-2024 Evaluation Requirement for Commutability of Reference Materials in Laboratory Medicine

Publish Date: 2024-09-18 Implement Date: 2025-03-18 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: JJF 2155-2024

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: -

Publish Date: 2024-09-18

Implement Date: 2025-03-18

Pages: 32 pages

Scope

This standard specifies the evaluation method for the interchangeability of standard substances in laboratory medicine, and is applicable to standard substances, quality control products, calibration products, and samples for interlaboratory quality assessment (EQA) and proficiency testing (PT) that require interchangeability evaluation. The uniformity and stability of samples are not within the scope of this standard. The content described in this standard assumes that the samples to be evaluated already meet the requirements for uniformity and stability. Note: This standard can also provide a reference basis for management departments, accreditation bodies, and other institutions to confirm or identify the capabilities of standard substance research and production institutions.

Development Information

Word Count: 38 Thousand words Pages: 32 pages

Referenced Standards

JJF 1001-1998 General Terms in Metrology and Their Definitions JJF 1001-2011 General Terms in Metrology and Their Definitions JJF 1005-2016 General Terms and Definitions Used in Connection with Reference Materials JJF 1644-2017 The Production of Reference Materials for Clinical Enzymology GB/T 19702-2005 In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Presentation of reference measurement procedures GB/T 19702-2021 In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for content and presentation of reference measurement procedures GB/T 21415-2008 In vitro diagnostic medical devices—Measurement of quantities in biological samples—Metrological traceability of values assigned to calibrators and control materials WS/T 356-2011 Guideline for evaluation of matrix effects and commutability WS/T 356-2024 Guidelines for Interchangeability Assessment of Reference Materials 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

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