10 Standard specifications
21
10 Standard specifications
Explanation of terms
Term
Explanation
Sterile barrier system
EN ISO 11607-2 replaces the terms “packaging”, “final packaging” and “primary
packaging” with the single term “sterile barrier system”. A sterile barrier system
is the minimum level of packaging which prevents the penetration of micro-
organisms and permits aseptic provision of the product at the location of use.
This includes transparent sterilization packaging, a sterilization bag, reusable
containers etc.
Protective packaging
The protective packaging is designed to provide the sterile barrier system with
protection up until its final application.
Packaging system
The sterile barrier system and protective packaging combine to form the
packaging system.
Peel test
A procedure to determine the peeling characteristics of paper/plastic composite
material in accordance with DIN EN 868-5, Appendix E.
General information regarding the packaging and sealing procedure
Comply with the following during packaging and sealing:
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Choose packaging of a sufficient size
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Packaging made of porous materials and plastic composite film should be filled to a max. of 3/4 of its
volume (DIN 58953-7).
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In packaging made of porous materials and plastic composite film, a minimum of 30 mm must remain
free between the sterilization material and the seam to be sealed (DIN 58953-7).
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When using transparent sterilization packaging from a roll, the removal side must have an overlap of
min. 1 cm between the cutting edge and the seal seam, enabling an aseptic removal (DIN 58953-7).
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Press together to remove all air before sealing.
Seal seam width
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The recommended nominal size for the width of the seal seam in DIN 58953-7 is only 6 mm.
Section 4.3.2 of DIN EN 868-5 requires a min. total seal width of 6 mm. Thus for grooved seal seams,
the sum of the individual grooved seams should amount to 6 mm.
This sealing device produces homogeneous seal seams of 10 mm in width with every sealing procedure.
Distance between the seal seam and the cutting edge
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Maintain the clearance between seal seam and cutting edge as prescribed in the standard:
DIN 58953-7 requires the maintenance of a sufficient overhang between the seal seam and the cutting
edge when working with transparent bags on the removal side. This ensures aseptic removal. MELAG
recommends a minimum overhang of 10 mm.
Seal seam stability
When using MELAfol transparent sterilization packaging, the sealing device guarantees a seal seam sta-
bility in accordance with DIN EN 868-5.
Storage duration for sterile medical devices
The following requirements apply to the storage of sterile medical devices:
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The rooms must be dry, cool and easy to clean.
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The rooms must not be accessible to everyday activity.
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We recommend protected storage in cupboards or drawers.
