GB/T 27424-2020 Active National standards

GB/T 27424-2020 Conformity assessment—Specification for biological quality control materials without metrological traceability

Publish Date: 2020-11-19 Implement Date: 2021-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 27424-2020

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Standardized management and general provisions

ICS Name: Product certification, institutional certification, and conformity assessment

Publish Date: 2020-11-19

Implement Date: 2021-06-01

Pages: 26 pages

Scope

This standard specifies the quality control requirements for the entire "life cycle" of non-traceable biological quality control products, including their development, acceptance, transportation, storage, use, and disposal, as well as the requirements for document preparation and label management during the quality control process.
This standard applies to the quality control of non-traceable biological quality control products in laboratory biological detection activities. The quality control of other non-traceable quality control products or standard materials can also be used for reference.

Development Information

Word Count: 46 Thousand words Pages: 26 pages

Referenced Standards

GB/T 15000.2-2019 Directives for the work of reference materials—Part 2:Selected terms and definitions 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 GB/T 15000.3-1994 Directives for the work of reference materials(3) General principles and statistic methods for certification of reference materials GB/T 15000.3-2008 Directives for the work of reference materials(3)—Reference materials—General and statistical principles for certification GB/T 15000.3-2023 Directives for the work of reference materials—Part 3:Reference materials—Characterization and assessment of homogeneity and stability GB/T 20468-2006 Guideline for internal quality control for quantitative measurements in clinical laboratory WS/T 356-2011 Guideline for evaluation of matrix effects and commutability WS/T 356-2024 Guidelines for Interchangeability Assessment of Reference Materials

Related Standards

GB/T 12707-1991 Abolished

GB/T 12707-1991 Directives for the grading of industrial product quality

Publish Date: 1991-01-05

GB/T 14237-1993 Abolished

GB/T 14237-1993 Manufacturer's declaration of export product conformity with standards

Publish Date: 1993-03-17

GB/T 14436-1993 Abolished

GB/T 14436-1993 General principles of industrial product guarantee documents

Publish Date: 1993-06-10

GB/T 15486-1995 Abolished

GB/T 15486-1995 Calibration and testing laboratory accreditation systems—General requirements for operation and recognition

Publish Date: 1995-02-14

GB/T 15483.1-1999 Replaced

GB/T 15483.1-1999 Proficiency testing by interlaboratory comparisons—Part 1:Development and operation of proficiency testing schemes

Publish Date: 1999-03-08

GB/T 15483.2-1999 Replaced

GB/T 15483.2-1999 Proficiency testing by interlaboratory comparisons—Part 2:Selection and use of proficiency testing schemes by laboratory accreditation bodies

Publish Date: 1999-03-08