GB/T 22576.4-2021 Active National standards

GB/T 22576.4-2021 Medical laboratories—Requirements for quality and competence—Part 4:Requirements in the field of clinical chemistry examination

Publish Date: 2021-05-21 Implement Date: 2022-06-01 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 22576.4-2021

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Quality management and quality assurance

Publish Date: 2021-05-21

Implement Date: 2022-06-01

Pages: 12 pages

Scope

This document specifies the requirements for the quality and competence of medical laboratories in the field of clinical chemistry testing.
This document is applicable to medical laboratories that conduct clinical chemistry testing, as well as to those that conduct quantitative clinical immunology testing.

Development Information

Word Count: 20 Thousand words Pages: 12 pages

Same series standard

GB/T 22576.2-2021 Medical laboratories—Requirements for quality and competence—Part 2:Requirements in the field of clinical hematological examination GB/T 22576.3-2021 Medical laboratories—Requirements for quality and competence—Part 3:Requirements in the field of urine examination GB/T 22576.5-2021 Medical laboratories—Requirements for quality and competence—Part 5:Requirements in the field of clinical immunology examination GB/T 22576.6-2021 Medical laboratories—Requirements for quality and competence—Part 6:Requirements in the field of clinical microbiological examination GB/T 22576.7-2021 Medical laboratories—Requirements for quality and competence—Part 7:Requirements in the field of transfusion medicine

Referenced Standards

GB/T 22576.1-2018 Medical laboratories—Requirements for quality and competence—Part 1:General requirements 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 403-2012 Analytical quality specifications for routine analytes in clinical biochemistry WS/T 407-2012 Guideline for comparability verification of quantitative results within one health care system WS/T 403-2024 Analysis Quality Standards for Commonly Used Clinical Chemistry Tests in WS/T 403-2024 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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