SN/T 3062.1-2011 Packing materials for terminally sterilized medical devices for import. Part 1:Validation requirements for forming,sealing and assembly processes (English Version)
This part of SN/T 3062 specifies the development and validation requirements for the sterilization and packaging process of imported medical devices. These processes include the forming, sealing and assembly of preformed sterile barrier systems, barrier systems and packaging systems. This section applies to the confirmation of the forming, sealing and assembly of sterilized preformed sterile barrier systems, barrier systems and packaging systems for imported medical devices. This section does not cover packaging requirements for sterile manufactured medical devices.
SN/T 3062.1-2011 Referenced Document
ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
SN/T 3062.1-2011 history
2011SN/T 3062.1-2011 Packing materials for terminally sterilized medical devices for import. Part 1:Validation requirements for forming,sealing and assembly processes