GB/T 13339-1991
Abolished
GB/T 22576.1-2026
Active
National standards
GB/T 22576.1-2026 Medical laboratories—Requirements for quality and competence—Part 1:General requirements
GB/T 22576.1-2026 Medical laboratories—Requirements for quality and competence—Part 1:General requirements
Price:
$ 159
Basic Information
Standard Code:
GB/T 22576.1-2026
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Quality management and quality assurance
Publish Date:
2026-01-28
Implement Date:
2026-08-01
Pages:
60 pages
Scope
This document specifies the requirements for the quality and competence of medical laboratories.
This document is applicable to medical laboratories in establishing management systems and assessing their own competence, as well as to laboratory users, regulatory authorities, and accreditation bodies in confirming or recognizing the competence of medical laboratories.
This document is also applicable to rapid testing.
Note: International, national, or regional regulations or requirements may also apply to specific content in this document.
Development Information
Replace the following standards
Referenced Standards
Adopt standards
ISO 15189:2022
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