BS EN 868-5:2018 pdf free.Packaging for terminally sterilized medical devices Sealable pouches and reels of porous materials and plastic film construction – Requirements and test methods.
BS EN 868-5 Reel material shall be constructed from one web of porous material and one web of plastic film,sealed together along parallel sides.Pouches shall be constructed from one web of porous material and one web of plastic film by sealingthree sides and may include an area to effect closure of the pouch.
The overall width of the seal(s) shall be not less than 6 mm.For ribbed seals, the sum of thewidths of the ribs shall be not less than 6 mm.The distance between the end of a pouch and the nearest edge of the width wise seal shall besufficient to enable the two webs to be separated and peeled apart.
NOTE The side seals can extend beyond the width wise seal to the end of the pouch provided that this doesnot impair peelability.
One of the materials of a pouch shall be:
a) provided with a thumb notch not more than 12 mm deep at either the top or bottom of the pouch or
at both ends; the bottom of the notch shall be at least 1 mm from the seal; or
b) lipped such that the length of one web is greater than the length of the other web by not less
than 1,0 mm.
NOTE The requirements of 4.3.4 do not apply to a reel that is sealed at the third side.
The pouch and/or reel shall be closed according to the manufacturer’s instructions.
NOTE1 For validation requirements for forming,sealing and assembly processes, see EN ISO 11607-2.
NOTE2 The closure and or sealing system can give the possibility to indicate whether or not the seal hasbeen opened.
lf one or more Type l indicator(s) [process indicator(s)] are printed on the pouches and reels, theindicator’s performance shall complywith the requirements ofENISO11140-1.Each individualindicatorshall be not less than 100 mm2 in area. Indicators shall not be affected by the sealing procedure.BS EN 868-5 pdf download.