GB/T 22576.2-2021 Active National standards

GB/T 22576.2-2021 Medical laboratories—Requirements for quality and competence—Part 2:Requirements in the field of clinical hematological 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

Basic Information

Standard Code: GB/T 22576.2-2021

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: 15 pages

Scope

本文件规定了医学实验室质量和能力的要求在临床血液学检验领域的要求，主要包括血细胞分析、血细胞形态学检查、血液寄生虫检查及出凝血检验的要求。
本文件适用于开展血液学检验的医学实验室。

Development Information

Drafting Units:

中国合格评定国家认可中心、国家卫生健康委临床检验中心、上海中医药大学附属龙华医院、中国人民解放军总医院

Drafting Persons:

彭明婷、周亚莉、翟培军、胡冬梅、李军燕、胡晓波、丛玉隆

Word Count: 26 Thousand words Pages: 15 pages

Same series standard

GB/T 22576.3-2021 Medical laboratories—Requirements for quality and competence—Part 3:Requirements in the field of urine 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 全国临床检验操作规程(第4版)　中华人民共和国国家卫生和计划生育委员会医政医管局 WS/T 347-2011 Guideline for the calibration of blood cell assays WS/T 359-2011 Collection and processing of blood specimens for testing plasma-based coagulation assays WS/T 405-2012 Reference intervals for blood cell analysis WS/T 406-2012 Analytical quality specifications for routine tests in clinical hematology WS/T 347-2024 Blood cell analysis calibration guideline WS/T 359-2024 Specimen collection and processing for commonly used items in thrombotic and hemorrhagic testing WS/T 406-2024 WS/T 406-2024 Analysis quality standards for commonly used items in clinical blood examination WS/T 641-2018 In-house quality control for quantitative clinical laboratory testing

Related Standards

GB/T 13339-1991 Abolished

GB/T 13339-1991 Guide to management of quality related costs

Publish Date: 1991-12-29

GB/T 13340-1991 Abolished

GB/T 13340-1991 Methods for determination and calculation of quality grading rate of products

Publish Date: 1991-12-29

GB/T 13341-1991 Abolished

GB/T 13341-1991 Methods for determination and accounting of quality failure rate

Publish Date: 1991-12-29

GB/T 19004.3-1994 Abolished

GB/T 19004.3-1994 Quality management and quality system elements—Part 3:Guidelines for processed materials

Publish Date: 1994-10-22

GB/T 19004.2-1994 Abolished

GB/T 19004.2-1994 Quality management and quality system element—Part 2:Guidelines for services

Publish Date: 1994-11-29

GB/T 19000.4-1995 Abolished

GB/T 19000.4-1995 Quality management and quality assurance standards—Part 4:Cuide to dependability programme management

Publish Date: 1995-11-14