EN 868-9-2009 pdf download.Packaging for terminally sterilized medical devices – Part 9:Uncoated nonwoven materials of polyolefines – Requirements and test methods.
This part of EN 868 provides test methods and values for uncoated nonwovert materials of polyolefines used for sterile barrier systems andlor packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.
NOTE 1 The need for a protective packaging may be determined by the manufacturer and the user.
This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add or modify the general requirements specified in
EN ISO 11607-1.
As such, the particular requirements in 4.2 to 4.3 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1.
NOTE 2 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, container filter, Indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements. including the determination of the acceptability of these materials during validation activities, may apply.
The materials specified In this part of EN 868 are intended for single use only.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
EN 20811, Textiles — Determination of resistance to water penetration — Hydrostatic pressure test
EN 21974, Paper— Determination of teanng resistance (Elmendorf method) (ISO 1974.1990)
EN ISO 536, Paper and board — Determination of grammage (ISO 536:1995)
EN ISO 1924-2, Paper and board — Determination of tensile properties — Part 2: Constant rate of elongation
method (ISO 1924-2:1994)
EN ISO 2758, Paper— Determination of bursting strength (ISO 2758:2001)
EN ISO 11607-1:2006, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
ISO 5636-3, Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method ISO 6588-2, Paper, board and puips — Determination of pH of aqueous extracts — Part 2: Hot extraction
ISO 8601. Data elements and interchange formats — Information interchange — Representation of dates and times
ASTM D 2724:1987, Test Methods for Bonded. Fused and Laminated Apparal Fabrics
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2006 apply.
4 Requirements
4.1 General
The requirements of EN ISO 11607-1 apply.
NOTE EN ISO 11607-1:2006. 5.1.4 refers to conditions dunng production and handling with respect to their impact
on the product (e.g. electrostatic conductivity, bioburden if applicable).
4.2 Materials
The uncoated material shall be translucent or opaque and made of continuous filaments of polyolefines of a high level of purity and shall not release any substances in such quantities as could constitute a health risk.
NOTE Attention is drawn to EN ISO 10993-1.
4.3 Performance requirements and test methods
4.3.1 No colour shall leach out of the material. Compliance shall be tested by visual examination of a hot extract prepared in accordance with the method given in Iso 6588-2 modified to test temperature of
(60±5)°C.
4.3.2 The average mass of 1 m’ of the conditioned material when tested in accordance with EN ISO 536 shall be within ± 7 % of the nominal value stated by the manufacturer.
4.3.3 The tensile strength of the conditioned material shall be not less than 4.8 kN/m in the machine direction and not less than 5,0 kN/m in the cross direction when tested in accordance with EN ISO 1924-2.
4.3.4 The internal tearing resistance of the conditioned material shall be not less than 1 000 mN in both machine and cross directions when tested in accordance with EN 21974.
4.3.5 The delamination factor of the conditioned material shall be not less than 1 N125,4 mm when tested in accordance with ASTM D 2724:1987.
4.3.6 The bursting strength of the conditioned material shall be not less than 575 kPa when tested in accordance with EN ISO 2758,
4.3.7 The air permeance of the conditioned material shall be not less than 1 mIPa s at an air pressure of
1.47 kPa when tested in accordance with ISO 5636-3.
NOTE This requirement need not to apply to materials solely for use in irradiation sterilization packaging.
4.3.8 The resistance to water penetration of the conditioned material shall be determined using the hydrostatic head test based on EN 20811. This test method is currently under revision and considering other test conditions (use of support screen with an open area greater than 50 % in order to avoid early fabric rupture), Minimum requirements will be set as soon as the revised test method is available. Manufacturers may report test results.
4.4 Marking of the 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 manufacturers or suppliers name or trade name, and address:EN 868-9-2009 pdf download.