BS EN 868-3:2009 pdf free download – Packaging for terminally sterilized medical devices Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5)一Requirements and test methods.
4.2.11 The wet bursting strength of the paper shall be not less than 35 kPa when tested in accordance with ISO 3689 using an immersion time of 10 mm.
4.2.12 The water repellency of the paper shall be such that the penetration time is not less than 20 s when tested in accordance with Annex C.
4.2.13 When tested in accordance with Annex D, the average of the pore diameters of the ten test pieces shall be lower than or equal to 35 pm. No value shall be greater than 50 pm.
4.2.14 The tensile strength of the conditioned paper shall be not less than 4,40 kN/m in machine direction and not less than 2,20 kN/m in cross direction when tested in accordance with EN ISO 1924-2.
4.2.15 The wet tensile strength of the paper shall be not less than 0,90 kN/m in machine direction and not less than 0,45 kN/m in cross direction when tested in accordance with ISO 3781.
4.2.16 The surface absorbency of each side of the paper shall be not more than 20 g/m2 when tested in accordance with EN 20535 using a 60 s exposure time (COBB method).
4.3 Marking
4.3.1 Protective packaging
The protective packaging shall be legibly and durably marked with the following information:
a) reference, stock or catalogue number;
b) quantity;
c) the manufacturer’s or supplier’s name or trade name, and address;
d) date of manufacture in accordance with ISO 8601;
e) lot number1
f) nominal mass in grams per square metre;
g) nominal sheet size or nominal width of rolls in millimetres and length in metres;
h) the recommended storage conditions.
4.3.2 Inner package
The inner package or inner label with reel material shall be legibly and durably marked with the information a), b), c), e) and f) according to 4.3.1.
5 Information to be supplied by the manufacturer
For requirements on information to be provided by the manufacturer national or regional legislation may apply, see in particular Directive 93/42/EEC, Annex I, Section 13.
Changes between this European Standard and EN 868-3:1999 are the following:
a) changes in order to align this European Standard with the EN ISO 11607 series, in particular by:
1) amending the main element of the title, the scope and the terminology;
2) using EN ISO 11607-1 as normative reference regarding the general requirements for materials, sterile barrier systems and packaging systems;
3) deleting requirements that are covered by EN ISO 11607 (such as requirements on raw materials, conditioning, quality of the material with regard to tears, creases, localised thickening, leaching of toxic substances);
b) in addition to a) first dash, the scope has been modified to:
1) explain that other requirements might be of relevance for additional materials being used inside a sterile barrier system;
2) clarify that the materials covered by this European Standard are intended for single use only;
c) an explanatory note has been inserted to refer the user of this European Standard to the general requirements on conditions during production and handling with respect to their impact on the product in EN ISO 11607;
d) informative details on Bendtsen roughness of the surface of the paper have been deleted;
e) requirements on marking have been amended;
f) requirements on information to be provided by the manufacturer have been added.