BS EN 868-10:2018 pdf free.Packaging for terminally sterilized medical devices.Adhesive coated nonwoven materials of polyolefines – Requirements and test methods.
BS EN 868-10 of EN 868 only introduces performance requirements and test methods that are specificto the products covered by this part of EN 868 but does not add or modify the general requirementsspecified in EN ISO 11607-1.
As such, the particular requirements in 4.3 can be used to demonstrate compliance with one ormore but not all of the requirements of EN ISO 11607-1.
NOTE1 Compliance to EN 868-10 does not automatically mean compliance to EN ISO 11607-1.
A confirmation of compliance to EN 868-10 shall contain a statement whether EN ISO 11607-1 is covered.NOTE2 When additional materials are used inside the sterile barrier system in order to ease the organization,drying or aseptic presentation (e.g. inner wrap, indicators, packing lists, mats,instrument organizer sets, trayliners or an additional envelope around the medical device) then other requirements, including the determinationof the acceptability of these materials during validation activities, can apply.
The coated material shall be translucent or opaque and made of continuous filaments ofpolyolefines of a high level of purity and shall not release any substances in such quantities as couldconstitute a health risk.
NOTEAttention is drawn to EN ISO 10993-1.
The coated material shall not react with, contaminate, transfer to, or adversely affect theproduct packed in it, before, during or after sterilization.
Conditioned material for testing shall comply with the test sample conditioning requirementsof EN ISO 11607-1:2017,Clause 4.
Performance requirements and test methods.No colour shall each out of the material. Compliance shall be tested by visual examination of ahot extract prepared in accordance with the method given in IS0 6588-2 modified to test temperature of(60±5)c.
The average mass of 1 m2 of the conditioned material when tested in accordance withENISO 536 shall be within ± 15 % of the nominal value stated by the manufacturer.
The tensile strength of the conditioned material shall be not less than 4,8 kN/m in themachine direction and not less than 5,0 kN/m in the cross direction when tested in accordance withEN ISO 1924-2.BS EN 868-10 pdf download.