BS EN 868-10:2018 pdf download

BS EN 868-10:2018 pdf download

BS EN 868-10:2018 pdf download.Packaging for terminally sterilized medical devices
1 Scope
This document specifies test methods and values for sealable adhesive coated nonwoven materials of polyolefines, manufactured from nonwovens complying with EN 868-9 used for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.The materials specified in this part of EN 868 are intended for single use only.
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 ISO 536, Paper and board一Determination of grammage (ISO 536)
ISO 811, Textiles 一Determination of resistance to water penetration一Hydrostatic pressure test
EN ISO 1924-2, Paper and board 一Determination of tensile properties . 一Part 2: Constant rate of elongation method (20 mm/min) (ISO 1924-2)
EN IsO 1974, Paper一Determination of tearing resistance一Elmendorf method (ISO 1974)
EN ISO 2758, Paper一Determination of bursting strength (ISO 2758)
EN ISO 11607-1:2017, 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)
This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add or modify the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.3 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. NOTE 1 Compliance to EN 868-10 does not automatically mean compliance to EN ISO 11607-1. A confirmation of compliance to EN 868- 10 shall contain a statement whether EN ISO 11607-1 is covered. NOTE 2 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, can apply.