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4.2 Materials4.2.1 Porous materialThe porous material shall comply with the requirements of either EN 868 part 2, 3, 6, 7, 9 or 10.When the porous material is to be used to manufacture preformed sterile barrier systems intended to beirradiation sterilized only, requirements for wet strength properties or permeability to air need not apply.4.2.2 Plastic film4.2.2.1 The plastic film shall be a composite of two or more layers. When tested after the intendedsterilization process in accordance with Annex B the plastics interply bond shall not separate nor becomecloudy.4.2.2.2 The plastic film shall be free from pinholes when tested in accordance with Annex C.4.2.2.3 When examined by unaided normal or corrected vision in transmitted light (daylight or goodartificial light) the plastic film shall be free from foreign matter and/or other imperfections that would adverselyaffect compliance with the requirements of 4.5.NOTE Slight continuous surface irregularities arising from the extrusion of the plastic film is not regarded as a defect.4.2.2.4 The plastic film shall be sealable to the porous material under the conditions specified by themanufacturer (see Clause 5, NOTE 1).4.2.2.5 The breaking factor of the plastics film shall be not less than 20 N per 15 mm width when testedin accordance with ASTM D 882:1995 (Method A).

4.4 Process indicatorIf one or more Class I indicator(s) (process indicator(s)) are printed on the pouches and tubes, the indicator’sperformance shall comply with the requirements of EN ISO 11140-1. Each individual indicator shall be not lessthan 100 mm² in area. Indicators shall not be affected by the sealing procedure.4.5 Performance requirements and test methods4.5.1 When tested in accordance with the method described in Annex D the strength of the seal joint shallbe not less than required for the intended purpose, both before and after being subjected to the sterilizationprocess.NOTE 1 The specification for seal strength before and after exposure to sterilization processes can differ.Minimum value for seal strength in (healthcare facility) shall be 1,5 N per 15 mm for steam sterilizationprocesses and 1,2 N per 15 mm for other sterilization processes.NOTE 2 For applications outside healthcare facilities, requirements are given in EN ISO 11607.Report whether the tail was supported or unsupported, see D.6.