BS EN 868-2:2017 pdf free
BS EN 868-2:2017 pdf free.Packaging for terminally sterilized medical devices- Part 2: Sterilization wrap – 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 4.2 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 868-2 does not automatically mean compliance to EN ISO 11607-1.
A confirmation of compliance to EN 868-2 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 See Annex E 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 1 1607-1:2009+A1:2014, Table B.1.
4.2.1 General
4.2.1.1 No colour shall leach out of the wrap. Compliance shall be tested by visual examination of a hot aqueous extract prepared in accordance with the method given in Iso 6588-2.
4.2.1.2 The average mass of 1 m2 of the conditioned wrap when tested in accordance with EN ISO 536 shall be within ± 5 % of the nominal value stated by the manufacturer.
4.2.1.3 The pH of an aqueous extract of the wraps shall be not less than 5 or greater than 8 when tested in accordance with ISO 6588.2, hot extraction method.
4.2.1.4 The chloride content of the wrap, calculated as sodium chloride, shall not exceed 0,05 % when tested in accordance with ISO 9197 using a hot extract prepared in accordance with ISO 6588-2:2012, 7.2 except that 2 ml of potassium chloride solution is not added.
4.2.1.5 The sulphate content of the wrap, calculated as sodium sulphate, shall not exceed 0,25 % when tested in accordance with ISO 9198, using a hot extract prepared in accordance with ISO 6588-2:2012, 7.2 except that 2 ml of potassium chloride solution is not added.
4.2.1.6 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 I %; calculated as the ratio of the D65 brightness measured with the 420 nm Ii V-cut-off filter in place to the D65 brightness measured without 420 nm IJV-cut-off filter.
4.2.1.7 When exposed at 25 cm from a IJV light source, the material shall not have per 0,01 m2 more than five fluorescent spots, each having an axis greater than 1 mm.
NOTE The IJV light to be used is the one described as per Annex C.
4.2.1.8 The manufacturer shall provide drapeability results and associated test method on request.
NOTE For test method, see e.g. EN ISO 9073-9 and Annex B.
4.2.2 Specific requirements
4.2.2.1 Wrap made of plain paper
4.2.2.1.1 The Internal tearing resistance of the conditioned wrap shall be not less than 500 mN in both machine and cross direction when tested in accordance with EN ISO 1974.
4.2.2.1.2 The air permeance of the conditioned wrap shall be not less than 1,7 urn/Pa s at an air pressure of 1,47 kPa when tested in accordance with ISO 5636-3.BS EN 868-2 pdf download.
