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Document Center List of Standards on Sterilized Packaging

ICS Code 11.080.30

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Up to Level 2:

• 11.080 (Sterilization and disinfection)

The following documents are a part of this series:

ASTM:

• ASTM-F1980 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

BSI:

• BS-EN-868-10 - Packaging for terminally sterilized medical devices. Adhesive coated nonwoven materials of polyolefines. Requirements and test methods
• BS-EN-868-2 - Packaging for terminally sterilized medical devices. Sterilization wrap. Requirements and test methods
• BS-EN-868-3 - Packaging for terminally sterilized medical devices. 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
• BS-EN-868-4 - Packaging for terminally sterilized medical devices. Paper bags. Requirements and test methods.
• BS-EN-868-5 - Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous and plastic film construction. Requirements and test methods
• BS-EN-868-6 - Packaging for terminally sterilized medical devices. Paper for low temperature sterilization processes. Requirements and test methods
• BS-EN-868-7 - Packaging for terminally sterilized medical devices. Adhesive coated paper for low temperature sterilization processes. Requirements and test methods
• BS-EN-868-8 - Packaging for terminally sterilized medical devices . Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods
• BS-EN-868-9 - Packaging for terminally sterilized medical devices. Uncoated nonwoven materials of polyolefines. Requirements and test methods
• BS-EN-ISO-11607-1 - Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems
• BS-EN-ISO-11607-2 - Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes

ISO:

• ISO-11607 - Packaging for terminally sterilized medical devices - Now ISO-11607-1 and ISO-11607-2
• 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

Other SDOs:

• ANSI/AAMI/ISO11607-1 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging
• ANSI/AAMI/ISO11607-2 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
• 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
• SS-EN-868-10 - Packaging materials and systems for medical devices which are to be sterilized - Part 10: Adhesive coated nonwoven materials of polyolefines for use in the manufacture of heat sealable pouches, reels and lids - 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 materials and systems for medical devices which are to be sterilized - 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