YY/T 0698.2-2009 Packaging materials for terminal sterilized medical devices—Part 2:Sterilization wrap—Requirements and test methods
YY/T 0698.2-2009 Packaging materials for terminal sterilized medical devices—Part 2:Sterilization wrap—Requirements and test methods
Basic Information
Scope
This part of YY/T 0698 provides requirements and test methods for materials of preformed barrier systems and packaging systems intended to maintain the sterility of medical devices prior to use.
This part does not add additional requirements to the general requirements of ISO 11607-1, so the specific requirements in 4.2 can be used to demonstrate compliance with one or more requirements of ISO 11607-1, but not all of its requirements.
Note 1: According to the manufacturer's specified intended use, the materials may also be suitable for other sterile areas or for surgical drapes specified in the YY/T 0506 series of standards.
Note 2: According to the manufacturer's specified intended use, the materials may also be suitable for container filters or as a wrapper within a container, in which case additional requirements and/or other possibilities may apply. See YY/T 0698.8.