BS 868-2:2017 pdf download – Packaging for terminally sterilized medical devices – Part 2: Sterilization wrap – Requirements and test methods

BS 868-2:2017 pdf download – Packaging for terminally sterilized medical devices – Part 2: Sterilization wrap – Requirements and test methods
4.2.2.1.9 The surface absorbency of each side of the paper shall be not more than 20 g/m2 whentested in accordance with EN ISO 535 using a 60 s exposure time (Cobb test).
4.2.2.2 Wrap made of creped paper
4.2.2.2.1 The wrap shall be creped to give increased flexibility.
4.2.2.2.2The elongation at break of the conditioned wrap shall be not less than 10 % in the machinedirection and not less than 2 % in the cross direction when tested by measurement of the elongation inconjunction with the test for tensile strength in accordance with EN iSo 1924-2.
4.2.2.2.3 The water repellency of the wrap shall be such that the penetration time is not less than 20swhen tested in accordance with Annex C.
4.2.2.2.4 When tested in accordance with Annex D, the average of the pore diameters of the ten testpieces shall be lower than or equal to 35 um. No value shall be greater than 50 um.
4.2.2.2.5The tensile strength of the conditioned wrap shall be not less than 1,33 kN/m in machinedirection and not less than 0,67 kN/m in cross direction when tested in accordance with EN ISO 1924-2.
4.2.2.2.6The wet tensile strength of the wrap shall be not less than 0,33 kN/m in machine directionand not less than 0,27 kN/m in cross direction when tested in accordance with ISO 3781.
4.2.2.3 Wrap made of nonwoven material
NOTE For the purpose of this specification, a nonwoven for sterile barrier systems can be described as abonded web made of textile and/or non-textile fibres.
4.2.2.3.1 The internal tearing resistance of the conditioned nonwoven wrap shall be not less than750 mN in the machine direction and 1 000 mN in the cross direction when tested in accordance withEN ISO 1974.
4.2.2.3.2 The bursting strength of the conditioned nonwoven wrap shall be not less than 130 kPawhen tested in accordance with EN ISO 2758.
4.2.2.3.3 The wet bursting strength of the nonwoven wrap shall be not less than 90 kPa when testedin accordance with ISO 3689 using an immersion time of 10 min.
4.2.2.3.4The elongation at break of the conditioned nonwoven wrap shall be not less than 5 % in themachine direction and not less than 7 % in the cross direction when tested in accordance withEN ISO 1924-2.
4.2.2.3.5 The resistance to water penetration of the nonwoven wrap shall be determined using thehydrostatic head test based on EN 20811.Test results shall be documented.
4.2.2.3.6The tensile strength of the conditioned nonwoven wrap shall be not less than 1,00 kN/m inmachine direction and not less than 0,65 kN/m in cross direction when tested in accordance withEN ISo 1924-2.
4.2.2.3.7The wet tensile strength of the nonwoven wrap shall be not less than 0,75 kN/m in machinedirection and not less than 0,50 kN/m in cross direction when tested in accordance with ISO 3781.
4.2.2.4 Wrap made of woven textile material
4.2.2.4.1 When the woven textile material is to be used to manufacture packaging intended to beirradiation sterilized only, it is not necessary for it to be permeable to air, so 4.2.2.4.6 need not to apply.
4.2.2.4.2 Requirements for the processing of reusable fabrics as given in EN ISO11607-1:2009,5.1.11and 5.1.12 apply and shall include the means to quantify and control the number of processing cycles.
4.2.2.4.3 The tensile strength, dry and wet, of the wrap shall be not less than 300 N in the warp andweft directions when tested in accordance with strip method of EN 29073-3.
4.2.2.4.4 The tear strength, dry and wet, of the wrap shall be not less than 6 N in the warp and weftdirections when tested in accordance with EN ISO 13937-1.The samples for the “wet”test shall beprepared according to EN 29073-3.
4.2.2.4.5 The bursting strength “dry” and “wet”of the wraps shall not be less than 100 kPa whentested in accordance with EN ISO13938-1.The preparation of samples for wet state testing shall beperformed according to EN 29073-3.
4.2.2.4.6The air permeability of the wrap shall be not more than 20 mm/s when tested in accordancewith EN ISo 9237.
4.2.2.4.7The resistance to water penetration of the woven textile material shall be determined usingthe hydrostatic head test based on EN 20811.Test conditions and test results shall be documented.