BS EN 868-7:2009 pdf free download – Packaging for terminally sterilized medical devices Part 7: Adhesive coated paper for low temperature sterilization processes一 Requirements and test methods.
Changes between BS EN 868-7 and EN 868-7:1999 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) the specific element of the title of this European Standard has been amended to indicate that the material covered by this European Standard can be applied to low temperature sterilization processes:
c) 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:
d) 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:
e) informative details on Bendtsen roughness of the surface of the paper have been deleted;
f) requirements on marking have been amended;
g) requirements on information to be provided by the manufacturer have been amended;
h) the test method on fluorescence has been inserted (this test method is based on DIN 58953-6 that was previously cited in this European Standard);
I) test reports in the annexes have been amended:
j) test method on the determination of the seal strength has been amended:
k) informative annex on dimensions and tolerances has been deleted;
l) text has been revised editorially (e.g. by updating normative and informative references).
NOTE This list is not exhaustive.
C.1 Apparatus
C.1.1 An ultra-violet light source and light meter with a range of wavelength of 315 nm to 380 nm.
C.1.2 Flat dish, approximately 200 mm x 150 mm x 15 mm.
C.1.3 Desiccator.
C.1.4 Stopwatch.
C.1.5 Powder dispenser, with a sieve of nominal aperture size between 0,125 mm and 0,150 mm at one end and closed at the other.
C.2 Reagent
Dry indicator powder prepared as described below.
Grind 20 g of sucrose in a mortar and pass through a sieve of nominal aperture size 0.063 mm to 0,075 mm. Dry the sieved sucrose in a desiccator over silica gel or in an oven at 105 C to 110 0. Mix lOg of the dry sucrose with 10 mg of sodium fluorescein and pass the mixture 5 times through a sieve of nominal aperture size 0.063 mm to 0,075 mm and finally transfer the dry indicator powder to the powder dispenser.
The dry indicator powder in the powder dispenser should be stored either in a desiccator or in an oven at 105 C to 110 °C.
C.3 Procedure
Take 10 test pieces of conditioned paper, each of size 60 mm x 60 mm. Separate the samples into two groups of five, one group with the ‘wire-side’ uppermost and the other with the ‘top-side’ uppermost. For each sample make two folds, each 10 mm high at right angles along two edges. Fill the flat dish with purified water at the conditioning temperature to a depth of 10 mm. Switch on the UV lamp and allow it to develop full output and adjust the distance of the lamp so that the irradiance at the level of the water in the dish is (300 ± 20) pW/cm2. Sprinkle the upper surface of a test piece thinly with indicator powder from the dispenser. Float the test piece on the water under the UV light source and note the time taken for a general fluorescence to appear. Repeat the procedure with the remaining nine test pieces.