GB/T 13339-1991
Abolished
GB/T 22576.3-2021
Active
National standards
GB/T 22576.3-2021 Medical laboratories—Requirements for quality and competence—Part 3:Requirements in the field of urine examination
GB/T 22576.3-2021 Medical laboratories—Requirements for quality and competence—Part 3:Requirements in the field of urine examination
Basic Information
Standard Code:
GB/T 22576.3-2021
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:
14 pages
Scope
本文件规定了医学实验室的质量和能力要求在尿液一般检验领域的要求。
本文件适用于开展尿液有形成分分析、尿液干化学分析及其他尿液成分定性检测的医学实验室。
注： 尿液生化成分定量分析的要求见GB/T 22576.4，尿液免疫学分析的要求见GB/T 22576.5，尿液微生物学检验的要求见GB/T 22576.6。
Development Information
Drafting Units:
中国合格评定国家认可中心、中国人民解放军总医院、中国医学科学院北京协和医院
Drafting Persons:
邓新立、胡冬梅、翟培军、周亚莉、李军燕、张时民、丛玉隆
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 22576.4-2021 Medical laboratories—Requirements for quality and competence—Part 4:Requirements in the field of clinical chemistry 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
WS/T 348-2011 Collection and processing of urine specimens
YY/T 0996-2015 Urine formed element analyzer(digital imaging automatic identification)
WS/T 348-2024 Urine specimen collection and processing (WS/T 348-2024)
WS/T 641-2018 In-house quality control for quantitative clinical laboratory testing
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