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...