Document Center List of Standards on Sterilized Packaging
ICS Code 11.080.30
Return to ICS Index.Up to Level 2:
The following documents are a part of this series:
ASTM:
- ASTM-F1980 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ASTM-F2981 - Standard Test Method for Verifying Nonporous Flexible Barrier Material Resistance to the Passage of Air
BSI:
- BS-EN-868-10 - Packaging for terminally sterilized medical devices
- BS-EN-868-2 - Packaging for terminally sterilized medical devices
- BS-EN-868-3 - Packaging for terminally sterilized medical devices
- BS-EN-868-4 - Packaging for terminally sterilized medical devices
- BS-EN-868-5 - Packaging for terminally sterilized medical devices
- BS-EN-868-5-TC - Tracked Changes. Packaging for terminally sterilized medical devices
- BS-EN-868-6 - Packaging for terminally sterilized medical devices
- BS-EN-868-6-TC - Tracked Changes. Packaging for terminally sterilized medical devices
- BS-EN-868-7 - Packaging for terminally sterilized medical devices
- BS-EN-868-8 - Packaging for terminally sterilized medical devices
- BS-EN-868-9 - Packaging for terminally sterilized medical devices
- BS-EN-ISO-11607-1 - Packaging for terminally sterilized medical devices
- BS-EN-ISO-11607-1-TC - Tracked Changes. Packaging for terminally sterilized medical devices
- BS-EN-ISO-11607-2 - Packaging for terminally sterilized medical devices
- BS-EN-ISO-11607-2-TC - Tracked Changes. Packaging for terminally sterilized medical devices
- BS-ISO-21881 - Sterile packaged ready for filling glass cartridges
- BS-ISO-21882 - Sterile packaged ready for filling glass vials
ISO:
- ISO-11607 - Packaging for terminally sterilized medical devices
- ISO-11607-1 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO-11607-1-AM1 - - Amendment 1
- ISO-11607-2 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
- ISO-11607-2-AM1 - - Amendment 1
- ISO-11607 PACKAGE - ISO 11607 - Terminally Sterilized Medical Devices Package.
- ISO-16775 - Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
- ISO-21881 - Sterile packaged ready for filling glass cartridges
- ISO-21882 - Sterile packaged ready for filling glass vials
Other SDOs:
- ANSI/AAMI/ISO11607-1 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging
- ANSI/AAMI/ISO11607-1-AM1 - Packaging For Terminally Sterilized Medical Devices - Part 1: Requirements For Materials, Sterile Barrier Systems, And Packaging, Amendment 1
- ANSI/AAMI/ISO11607-2 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
- ANSI/AAMI/ISO11607-2-AM1 - Packaging For Terminally Sterilized Medical Devices - Part 2: Validation Requirements For Forming, Sealing, And Assembly Processes, Amendment 1
- DIN-EN-ISO-11607-1 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- DIN-EN-ISO-11607-2 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
- EN-868-10 - Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
- EN-868-2 - Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
- EN-868-3 - Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
- EN-868-4 - Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
- EN-868-5 - Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
- EN-868-6 - Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
- EN-868-7 - Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
- EN-868-8 - Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
- EN-868-9 - Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
- EN-ISO-11607-1 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- EN-ISO-11607-2 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
- SIS-CEN-ISO/TS-16775 - Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014)
- SIS-EN-ISO-11607-1 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
- SIS-EN-ISO-11607-2 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
- SS-EN-868-10 - Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
- SS-EN-868-2 - Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
- SS-EN-868-3 - Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
- SS-EN-868-4 - Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
- SS-EN-868-5 - Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
- SS-EN-868-6 - Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
- SS-EN-868-7 - Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
- SS-EN-868-8 - Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
- SS-EN-868-9 - Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
- SS-EN-ISO-11607-1 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
- SS-EN-ISO-11607-2 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)