JJF 1644-2017 Active National Metrology Technical Specifications JJF

JJF 1644-2017 The Production of Reference Materials for Clinical Enzymology

JJF 1644-2017 The Production of Reference Materials for Clinical Enzymology

Publish Date: 2017-09-26 Implement Date: 2017-12-26 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: JJF 1644-2017

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: -

Publish Date: 2017-09-26

Implement Date: 2017-12-26

Pages: 16 pages

Scope

This standard specifies the requirements for the development planning, preparation, uniformity evaluation, stability evaluation, interchangeability evaluation, value determination, uncertainty assessment, development reports and certificates, packaging and storage of clinical enzyme standard materials (hereinafter referred to as enzyme standard materials). It is applicable to guiding the development of first- and second-level certified standard materials in clinical enzymology, and can also provide reference for the development of other types of standard materials and quality control samples for clinical enzyme measurements.

Development Information

Word Count: 19 Thousand words Pages: 16 pages

Referenced Standards

WS/T 419-2013 The values of enzymatic activity concentrations assigned for the reference materials WS/T 356-2011 Guideline for evaluation of matrix effects and commutability CLSIEP30-A CLSIEP 14-A3 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 1265-2010 Terms and Definitions for Biometrology JJF 1265-2022 Terms and Definitions for Biometrology JJF 1343-2012 General and Statistical Principles for Characterization of Reference Materials JJF 1343-2022 Characterization,Homogeneity and Stability Assessment of Reference Materials JJF 1059.1-2012 Evaluation and Expression of Uncertainty in Measurement JJF 1186-2007 The Rules for Drafting of Contents for Certificates and Labels of Certified Reference Materials JJF 1186-2018 Requirements of Reference Materials Certificates and Labels JJF 1218-2009 The Rule for Drafting in Report of Reference Materials GB/T 19703-2005 In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Description of reference materials GB/T 19703-2020 In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for certified reference materials and the content of supporting documentation JJF 1218-2025 Requirements for Drafting of Reference Material Research and Development Reports

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