GB/T 13339-1991
Abolished
GB/T 29790-2020
Active
National standards
GB/T 29790-2020 Point-of-care testing (POCT)—Requirements for quality and competence
GB/T 29790-2020 Point-of-care testing (POCT)—Requirements for quality and competence
Basic Information
Standard Code:
GB/T 29790-2020
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Quality management and quality assurance
Publish Date:
2020-11-19
Implement Date:
2021-12-01
Pages:
12 pages
Scope
This standard specifies the special requirements applicable to point-of-care testing (POCT), and it should be used in conjunction with GB/T 22576.1-2018. The requirements of this standard apply to point-of-care testing conducted in hospitals, clinics, or medical institutions providing mobile medical services. This standard can be applied to percutaneous measurements, breath analysis, and in-vivo monitoring of physiological parameters.
This standard does not include patient self-testing conducted at home or in the community, but the elements of this standard can be applied.
Note: Local, regional, and national regulations should be taken into account.
Development Information
Replace the following standards
Referenced Standards
Adopt standards
ISO 22870:2016
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