GB/T 13339-1991
Abolished
GB/T 22576.1-2018
Active
National standards
GB/T 22576.1-2018 Medical laboratories—Requirements for quality and competence—Part 1:General requirements
GB/T 22576.1-2018 Medical laboratories—Requirements for quality and competence—Part 1:General requirements
Basic Information
Standard Code:
GB/T 22576.1-2018
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Quality management and quality assurance
Publish Date:
2018-12-28
Implement Date:
2019-07-01
Publisher:
国家市场监督管理总局、中国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:
47 pages
Scope
GB/T 22576的本部分规定了医学实验室质量和能力的要求。
本部分适用于医学实验室建立质量管理体系和评估自己的能力，也可用于实验室客户、监管机构和认可机构确认或承认医学实验室的能力。
Development Information
Drafting Units:
北京市医疗器械检验所、中国合格评定国家认可中心、国家卫生计生委临床检验中心、中国人民解放军总医院
Drafting Persons:
贺学英、翟培军、胡冬梅、陈文祥、郭健、邓新立、丛玉隆
Replace the following standards
Referenced Standards
GB/T 27025-2008 General requirements for the competence of testing and calibration laboratories
ISO/IEC 17000
ISO/IEC指南2
ISO/IEC指南99
Adopt standards
ISO 15189:2012
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