GB/T 22576.5-2021 Active National standards

GB/T 22576.5-2021 Medical laboratories—Requirements for quality and competence—Part 5:Requirements in the field of clinical immunology 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 22576.5-2021

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质量和能力的要求在临床免疫学定性检验领域的要求。
本文件适用于开展在免疫学定性检验的临床实验室。
注：临床免疫学定量检验领域的要求见GB/T 22576.4。

Development Information

Drafting Units:

中国合格评定国家认可中心、江苏省临床检验中心、国家卫生健康委临床检验中心、福建医科大学附属协和医院

Drafting Persons:

许斌、李军燕、翟培军、胡冬梅、周亚莉、李金明、曹颖平

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

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