YY/T 0681.3-2010
Active
T/CAMDI 057-2020
Active
Group standards
Standard Guidelines for the Preparation of Specifications for Sterilizable Peelable Bags (T/CAMDI 057-2020)
T/CAMDI 057-2020
Price:
$ 20.00
Basic Information
Standard Code:
T/CAMDI 057-2020
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Public medical equipment
ICS Name:
Disinfection and packaging
Publish Date:
2020-12-31
Implement Date:
2021-07-01
Scope
Main technical content: This document sets out the technical requirements for the materials and manufacturing of sterile barrier systems, physical performance, performance requirements, dimensions, appearance, printing, packaging marking, etc. in the form of a product specification, providing a guide for both suppliers and users to reach an agreement. The requirements covered in this document apply to suppliers providing sterile barrier systems and device manufacturers using sterile barrier systems. This guide can be used as a reference basis for both parties to formulate quality agreements or technical requirements. This document is applicable to herringbone three-side sealed bags, top-sealed bags, and corner-peel three-side sealed bags. Other bag-making forms can also be implemented with the consensus of both suppliers and users.
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