GB 18278-2000
Replaced
YY/T 0567.1-2013
Active
Industry standards-Medicine
YY/T 0567.1-2013 Aseptic processing of health care products—Part 1:General requirements
YY/T 0567.1-2013 Aseptic processing of health care products—Part 1:General requirements
Basic Information
Standard Code:
YY/T 0567.1-2013
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Public medical equipment
ICS Name:
Integrated disinfection and sterilization
Publish Date:
2013-10-21
Implement Date:
2014-10-01
Pages:
42 pages
Scope
This part of YY/T 0567 specifies the general requirements and guidelines for the development, validation, and routine control of the manufacturing process of sterile-processed healthcare products.
This part covers the general requirements and guidelines for the entire sterile processing process. Other parts specify the specific requirements and guidelines for various specialized/dedicated processes and methods, such as filtration, freeze-drying, online cleaning, online sterilization, and isolation systems.
Note: This part of YY/T 0567 does not replace or substitute for national regulatory requirements, such as "Good Manufacturing Practices (GMPs)" and/or pharmaceutical requirements that fall under the jurisdiction of specific countries or regions.
Development Information
Replace the following standards
Adopt standards
ISO 13408-1:2008
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