EN 868-5:2018 pdf free download.Packaging for terminally sterilized medical devices – Part5:Sealable pouches and reels of porous materials and plastic film construction – Requirements and test methods.
EN 868-5:2018 specifies test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4.
The EN ISO 11607 series consists of two parts under the general title “Packaging for terminally sterilized medical devices”. Part 1 of this series specifies general requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. Part 2 of this series specifies validation requirements for forming, sealing and assembly processes.
General requirements for all types of sterile barrier systems are provided by EN ISO 11607-1.
The EN 868 series can be used to demonstrate compliance with one or more of the requirements specified in EN ISO 11607-1.
CEN/TC 102/WG 4 also appreciates the initiatives of CEN with regard to the minimization of adverse environmental impacts by standards. It was agreed that this subject should be given priority during the next edition of the EN ISO 11607 series that is the basic reference for all parts of the EN 868 series.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
EN 868-2:2017, Packaging for terminally sterilized medical devices — Part 2: Sterilization wrap — Requirements and test methods
EN 868-3:2017,. 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 868-6:2017, Packaging for terminally sterilized medical devices — Part 6: Paper for low temperature sterilization processes — Requirements and test methods
EN 868-7:2017, Packaging for terminally sterilized medical devices — Part 7: Adhesive coated paper for low temperature sterilization processes — Requirements and test methods
EN 868-9:20 18, Packaging for terminally sterilized medical devices — Part 9: Uncoated nonwoven materials of polyolefines — Requirements and test methods
EN 868-10:2018, Packaging for terminally sterilized medical devices — Part 10: Adhesive coated nonwoven materials of polyolefines — Requirements and test methods