GB/T 13339-1991
Abolished
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
GB/T 22576.4-2021 Medical laboratories—Requirements for quality and competence—Part 4:Requirements in the field of clinical chemistry examination
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
Publisher:
国家市场监督管理总局、国家标准化管理委员会
Technical Committee:
全国医用临床检验实验室和体外诊断系统标准化技术委员会(SAC/TC 136)
Pages:
12 pages
Scope
本文件规定了医学实验室的质量和能力的要求在临床化学检验领域的要求。
本文件适用于开展临床化学检验的医学实验室，也适用于开展临床免疫学定量检验的医学实验室。
Development Information
Drafting Units:
中国合格评定国家认可中心、北京医院、中国人民解放军第三零二医院、中国医学科学院北京协和医院
Drafting Persons:
郭健、李军燕、翟培军、胡冬梅、周亚莉、毛远丽、邱玲
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
Related Standards
GB/T 13340-1991
Abolished
GB/T 13340-1991 Methods for determination and calculation of quality grading rate of products
GB/T 13341-1991
Abolished
GB/T 13341-1991 Methods for determination and accounting of quality failure rate
GB/T 19004.3-1994
Abolished
GB/T 19004.3-1994 Quality management and quality system elements—Part 3:Guidelines for processed materials
GB/T 19004.2-1994
Abolished
GB/T 19004.2-1994 Quality management and quality system element—Part 2:Guidelines for services
GB/T 19000.4-1995
Abolished