BS EN 868-7-2017 pdf free download.Packaging for terminally sterilized medical devices Part 7: Adhesive coated paper for low temperature sterilization processes — Requirements and test methods
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2009+A1:2014 apply.
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.
4.2.5 The chloride content of the paper, calculated as sodium chloride, shall not exceed 0,05 % when tested in accordance with ISO 9197 using an hot extract prepared in accordance with ISO 6588-2:2012, 7.2 except that 2 ml of potassium chloride solution is not added.
4.2.6 The sulphate content of the paper, calculated as sodium sulphate, shall not exceed 0,25 % when tested in accordance with ISO 9198, using an hot extract prepared in accordance with ISO 6588-2:2012, 7.2 except that 2 ml of potassium chloride solution is not added.
4.2.7 When tested in accordance with ISO 2470-2 the material shall not exhibit an increase in D65 brightness, due to the optical brightener agents, of more than 1 %; calculated as the ratio of the D65 brightness measured with the 420 nm UV-cut-off filter in place to the D65 brightness measured without 420 nm UV-cut-off filter.
4.2.8 When exposed at 25 cm from a UV light source, the material shall not have per 0,01 m 2 more than five fluorescent spots, each having an axis greater than 1 mm. NOTE The UV light to be used is the one described as per Annex B.
4.2.9 The internal tearing resistance of the conditioned paper shall be not less than 300 mN in both machine and cross directions when tested in accordance with EN ISO 1974. 4.2.10 The air permeance of the conditioned coated paper shall be not less than 0,2 µm/Pa ⋅ s and not more than 6,0 µm/Pa ⋅ s when tested in accordance with ISO 5636-3.
4.2.11 The bursting strength of the conditioned paper shall be not less than 200 kPa when tested in accordance with EN ISO 2758.
4.2.12 The wet bursting strength of the paper shall be not less than 35 kPa when tested in accordance with ISO 3689 using an immersion time of 10 min.
4.2.13 The water repellency of the paper shall be such that the penetration time is not less than 20 s when tested in accordance with Annex B.BS EN 868-7 pdf download.