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UNE-EN ISO 11607-1:2020/A1:2024 UNE
Status: Current/2024-05-22
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1: Application of risk management (ISO 11607-1:2019/Amd 1:2023)
UNE-EN ISO 11607-2:2020/A1:2024 UNE
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1: Application of risk management (ISO 11607-2:2019/Amd 1:2023)
UNE-EN ISO 11607-1:2020/A11:2022 UNE
Status: Vigente/ 2022-12-21
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
UNE-EN ISO 11607-2:2020/A11:2022 UNE
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
UNE-CEN ISO/TS 16775:2021 UNE
Status: Vigente/ 2022-01-01
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021) (Endorsed by Asociación Española de Normalización in January of 2022.)
UNE-EN ISO 11607-1:2020 UNE
Status: Vigente/ 2020-09-23
UNE-EN ISO 11607-2:2020 UNE
UNE-EN 868-9:2019 UNE
Status: Vigente/ 2019-10-09
Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
UNE-EN 868-10:2019 UNE
Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
UNE-EN 868-8:2019 UNE
Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
UNE-EN 868-5:2019 UNE
Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
UNE-EN 868-6:2017 UNE
Status: Vigente/ 2017-11-02
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
UNE-EN 868-7:2017 UNE
Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
UNE-EN 868-2:2017 UNE
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
UNE-EN 868-4:2017 UNE
Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
UNE-EN 868-3:2017 UNE
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
UNE 56932:2008 UNE
Status: Vigente/ 2017-02-16
Cork stoppers. Packaging and labelling.
ISO 11607-1:2019/Amd 1:2023 ISO
Status: Published/ 2023-09-13
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1: Application of risk management
ISO 11607-2:2019/Amd 1:2023 ISO
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1: Application of risk management
ISO/TS 16775:2021 ISO
Status: Published/ 2021-11-05
Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
ISO 21881:2019 ISO
Status: Published/ 2019-10-18
Sterile packaged ready for filling glass cartridges
ISO 21882:2019 ISO
Sterile packaged ready for filling glass vials
ISO 11607-1:2019 ISO
Status: Published/ 2019-01-31
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2019 ISO
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
PNE-EN 868-2 PROY
Status: Procedure
PNE-EN 868-3 PROY
PNE-EN 868-4 PROY
PNE-EN 868-6 PROY
PNE-EN 868-7 PROY
UNE-EN ISO 11607-2:2017 UNE
Status: Anulada/ 2020-09-23
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006, including Amd 1:2014)
UNE-EN ISO 11607-1:2017 UNE
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014)
UNE-EN 868-10:2009 UNE
Status: Anulada/ 2019-10-09
UNE-EN 868-8:2009 UNE
UNE-EN 868-9:2009 UNE
UNE-EN 868-5:2009 UNE
UNE-EN 868-7:2009 UNE
Status: Anulada/ 2017-11-02
UNE-EN 868-4:2009 UNE
UNE-EN 868-3:2009 UNE
UNE-EN 868-6:2009 UNE
UNE-EN 868-2:2009 UNE
UNE-EN ISO 11607-2:2007 UNE
Status: Anulada/ 2017-10-11
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
UNE-EN ISO 11607-1:2009 UNE
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
UNE-EN ISO 11607-2:2007/A1:2014 UNE
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006/Amd 1:2014)
UNE-EN ISO 11607-1:2009/A1:2014 UNE
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006/Amd 1:2014)
UNE-EN ISO 11607-1:2007 UNE
Status: Anulada/ 2010-03-22
UNE-EN 868-2:2000 UNE
Status: Anulada/ 2009-12-02
PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED. PART 2: STERILIZATION WRAP. REQUIREMENTS AND TEST METHODS.
UNE-EN 868-7:2000 UNE
PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED. PART 7: ADHESIVE COATED PAPER FOR THE MANUFACTURE OF HEAT SEALABLE PACKS FOR MEDICAL USE FOR STERILIZATION BY ETHYLENE OXIDE OR IRRADIATION. REQUIREMENTS AND TEST METHODS.
UNE-EN 868-3:2000 UNE
PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED. 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.
UNE-EN 868-4:2000 UNE
PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED. PART 4: PAPER BAGS. REQUIREMENTS AND TEST METHODS.
UNE-EN 868-5:2000 UNE
PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED. PART 5: HEAT AND SELF-SEALABLE POUCHES AND REELS OF PAPER AND PLASTIC FILM CONSTRUCTION. REQUIREMENTS AND TEST METHODS.
