BS EN 868-7:2017 pdf download.Packaging for terminally sterilized medical devices Part 7: Adhesive coated paper for low temperature sterilization processes — Requirements and test methods.
4 Requirements 4.1 General For any material, preformed sterile barrier system or sterile barrier system, the requirements of EN ISO 11607-1 shall apply. 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 868–7 does not automatically mean compliance to EN ISO 11607-1. A confirmation of compliance to EN 868-7 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, container filter, 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.
4.2 Performance requirements and test methods NOTE 1 See Annex G for repeatability and reproducibility of the test methods: pore diameters, sulphate content, chloride content and water repellency. For information on statement of precision and/or bias, repeatability and reproducibility of other test methods, see EN ISO 11607-1:2009+A1:2014, Table B.1. NOTE 2 Test methods included in Annex D “regularity of seal adhesive coatings on paper”, Annex E “Determination of mass per unit area of uncoated paper and adhesive coating” and Annex F “Determination of seal strength and visual inspection of adhesive coating” have no statement of precision and bias or repeatability and reproducibility, yet. 4.2.1 When the paper is to be used to manufacture packaging intended to be irradiation sterilized only, it is not necessary for it to have wet strength properties or any permeability to air, so 4.2.12 and 4.2.17 need not apply. 4.2.2 No colour shall leach out of the paper. Compliance shall be tested by visual examination of a hot aqueous extract prepared in accordance with the method given in ISO 6588-2. 4.2.3 The average mass of 1 m 2 of the conditioned coated paper when tested in accordance with EN ISO 536 shall be within ± 7,5 % of the nominal value stated by the manufacturer. 4.2.4 The pH of an aqueous extract of the coated paper shall be not less than 5 or greater than 8 when tested in accordance with ISO 6588-2, hot extraction method.BS EN 868-7 pdf download.