GB 18278-2000
Replaced
T/CQAP T/CQAP/3001-2020
Active
Group standards
T/CQAP T/CQAP/3001-2020 Requirements for the Release of Sterilized Aseptic Products by Moist Heat Sterilization
T/CQAP T/CQAP/3001-2020
Price:
$ 20.00
Basic Information
Standard Code:
T/CQAP T/CQAP/3001-2020
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated disinfection and sterilization
Publish Date:
2020-07-01
Implement Date:
2020-10-01
Scope
Scope: This standard specifies the basic conditions and general requirements necessary for the release of parameters of sterile products produced by the final wet heat sterilization process; Main technical content: It refers to, on the basis of strictly implementing the Drug Production Quality Management Standards (abbreviated as GMP), evaluating the sterility assurance of the products based on the information obtained from monitoring and inspecting the whole production process, and ensuring that the key parameters meet the established standards, so as to confirm that the non-sterile probability specified in the Chinese Pharmacopoeia (i.e., the sterility assurance level, sal) is no higher than 10-6, thus replacing the release system of the final product sterility inspection.
Development Information
Related Standards
GB 18281.1-2000
Replaced
GB 18281.1-2000 Sterilization of health care products—Biological indicators—Part 1:General
GB 18281.2-2000
Replaced
GB 18281.2-2000 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization
GB 18281.3-2000
Replaced
GB 18281.3-2000 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization
GB 18282.1-2000
Replaced
GB 18282.1-2000 Sterilization of health care products—Chemical indicators—Part 1:General requirements
YY/T 0567.2-2005
Replaced