YY/T 0681.3-2010
Active
T/CAMDI 015-2018
Active
Group standards
T/CAMDI 015-2018 Sterile medical device initial packaging production quality management specifications
T/CAMDI 015-2018 Sterile medical device initial packaging production quality management specifications
Price:
$ 20.00
Basic Information
Standard Code:
T/CAMDI 015-2018
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Disinfection and packaging
Publish Date:
2016-12-22
Implement Date:
2017-01-01
Scope
Main technical content: Chapter 1: General Provisions Chapter 2: Organizations and Personnel Chapter 3: Plant and Facilities Chapter 4: Equipment Chapter 5: Document Management Chapter 6: Design and Development Chapter 7: Procurement Chapter 8: Production Management Chapter 9: Quality Control Chapter 10: Sales and After-sales Service Chapter 11: Non-conforming Product Control Chapter 12: Monitoring, Analysis, and Improvement
Development Information
Related Standards
YY/T 0681.4-2010
Replaced
YY/T 0681.4-2010 Test methods for sterile medical device package—Part 4:Detecting seal leaks in porous packages by dye penetration
YY/T 0681.10-2011
Active
YY/T 0681.10-2011 Test methods for sterile medical device package—Part 10:Test for microbial barrier ranking of porous package material
GB/T 19633.1-2015
Active
GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems
GB/T 19633.2-2015
Active
GB/T 19633.2-2015 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes
YY/T 0681.14-2018
Active