BS EN 868-10-2018 pdf free download.Packaging for terminally sterilized medical devices Part 10: Adhesive coated nonwoven materials of polyolefines – Requirements and test methods
This document specifies test methods and values for sealable adhesive coated nonwoven materials of polyolefines, manufactured from nonwovens complying with EN 868‑9 used for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.
Other than the general requirements as specified in EN ISO 11607‑1 and EN ISO 11607‑2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
The materials specified in this part of EN 868 are intended for single use only.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements 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 ISO 536, Paper and board — Determination of grammage (ISO 536)
ISO 811, Textiles — Determination of resistance to water penetration — Hydrostatic pressure test
EN ISO 1924‑2, Paper and board — Determination of tensile properties — Part 2: Constant rate of elongation method (20 mm/min) (ISO 1924-2)
EN ISO 1974, Paper — Determination of tearing resistance — Elmendorf method (ISO 1974)
EN ISO 2758, Paper — Determination of bursting strength (ISO 2758)
EN ISO 11607‑1:2017, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014)
ISO 5636‑3, Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method
ISO 6588‑2, Paper, board and pulps — 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 D2724, Standard Test Methods for Bonded, Fused, and Laminated Apparel Fabrics
ASTM F88/F88M:2015, Standard Test Method for Seal Strength of Flexible Barrier Materials
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 11607‑1:2017 apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at http://www.iso.org/obp
4 Requirements
4.1 General
For any material, preformed sterile barrier system or sterile barrier system, the requirements of EN ISO 11607‑1 shall apply.
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 4.3 can be used to demonstrate compliance with one or
more but not all of the requirements of EN ISO 11607‑1.
NOTE 1 Compliance to EN 868‑10 does not automatically mean compliance to EN ISO 11607‑1.
A confirmation of compliance to EN 868‑10 shall contain a statement whether EN ISO 11607‑1 is covered.
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, 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, can apply.
4.2 Materials
4.2.1 The coated 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.
4.2.2 The coated material shall not react with, contaminate, transfer to, or adversely affect the product packed in it, before, during or after sterilization.
4.2.3 Conditioned material for testing shall comply with the test sample conditioning requirements of EN ISO 11607‑1:2017, Clause 4.
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 2 of the conditioned material when tested in accordance with EN ISO 536 shall be within ± 15 % 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 ISO 1974.
4.3.5 If the nature of the material allows a delamination to be initiated, the delamination factor of the conditioned material shall be not less than 1 N/25,4 mm when tested in accordance with ASTM
D2724.
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 0,3 µm/Pa ⋅ s at an air pressure of 1,47 kPa when tested in accordance with ISO 5636‑3.
NOTE This requirement can be ignored for materials solely for use in irradiation sterilization packaging.BS EN 868-10 pdf download