GB/T 13339-1991
Abolished
T/CECCEDA 002-2023
Active
Group standards
T/CECCEDA 002-2023 CAR-T cell production and disposable production specifications
T/CECCEDA 002-2023 CAR-T cell production and disposable production specifications
Price:
$ 20.00
Basic Information
Standard Code:
T/CECCEDA 002-2023
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
Quality management and quality assurance
Publish Date:
2023-03-01
Implement Date:
2023-03-01
Scope
Main technical content: The standard specifies the model specifications, performance indicators, and inspection methods of disposable fully enclosed consumables for seven components and 12 specifications of autologous cell culture, sampling, and harvesting in the preparation process of CAR-T immune cell products. The standard mainly includes normative reference documents and reference materials, terms and definitions, basic requirements, process control, document management, and testing and verification.
Development Information
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