WS/T 420-2013 Replaced Industry standards-Health

WS/T 420-2013 Verification of analytical performance of quantitative kits by clinical laboratory

Publish Date: 2013-07-16 Implement Date: 2013-12-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: WS/T 420-2013

Standard Type: Industry standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Health

ICS Name: Integrated medical science and healthcare devices

Publish Date: 2013-07-16

Implement Date: 2013-12-01

Pages: 42 pages

Scope

This standard specifies the methods for clinical laboratories to verify the analytical performance of commercial quantitative reagent kits.
This standard applies to the verification of the analytical performance of commercial quantitative reagent kits in clinical laboratories. For some commercial quantitative reagent kits, this standard may not be fully applicable, and appropriate modifications can be made based on this standard.
This standard is not applicable to a comprehensive and systematic evaluation of the analytical performance of commercial quantitative reagent kits. If clinical laboratories have made significant modifications to the operating steps, dosages, calculations, etc. of commercial quantitative reagent kits, it is not sufficient to conduct only verification. In this case, more comprehensive and complex validation methods should be used.

Development Information

Word Count: 77 Thousand words Pages: 42 pages

Referenced Standards

GB/T 22576-2008 Medical laboratories—Particular requirements for quality and competence ISO 18113:2009 CLIA88

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