EN 868-3-2009 pdf 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) – Requirements and test methods.
This part of EN 868 provides test methods and values for paper, used in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) used as sterile barrier systems andlor packaging systems that are intended to maintain sterlhty of terminally sterilized medical devices to the point of use.
NOTE I 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 coveted 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 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 oi’ aseptic presentatlon (e.g. Inner wrap, antainer 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. NOTE 3 Applicable stenlizaton methods are specified by the manufacturer,
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 20187. Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples (ISO 187:1990)
EN 20535, Paper and board — Determination of water absorptiveness — Cobb method (ISO 535:1991)
EN 21974. Paper— Determination of tearing resistance (Elmendorfrnethod) (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 3689. Paper and board — Determination of bursting strength after immersion in water ISO 3781. Paper and board — Determination of tensile strength after immersion in water
ISO 5636-3. Paper and board — Determination of air permeance (medium range) — Part 3: Bendisen method ISO 65882:2005, Paper. board and puips — Determination of pH of aqueous extracts — Part 2: Hot extraction
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EN 868-3:2009 (E)
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and
times
ISO 9197, Paper, board and puips — Determination of water-soJubie chlorides
ISO 9198, Paper, board and pulp — Determination of water-soluble sulfates
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 during production and handling with respect to their impact on the product (e.g. electrostatic conductivity. bloburden if applicable).
4.2 Performance requirements and test methods
4.2.1 The requirements of 4.2.11 and 4.2.15 do not apply to materials solely used in irradiation sterilization packaging.
4.2.2 No colour shall leach out of the paper. Compliance shall be tested by visual examination of a hot aqueous extract prepared in accordance with the method given in ISO 6588-2.
4.2.3 The average mass of 1 m’ of the conditioned paper when tested in accordance with EN ISO 536 shall be within ± 5 % of the nominal value stated by the manufacturer.
4.2.4 The pH of an aqueous extract of the paper shall be not less than 5 nor greater than 8 when tested In accordance with ISO 6588-2.
4.2.5 The chloride content of the paper, calculated as sodium chloride, shall not exceed 0.05 % when tested in accordance with ISO 9197 using a hot extract prepared In accordance with ISO 6588-2:2005, 7.2 except that 2 ml of potassium chloride solution is not added.
4.2.6 The sulphate content of the paper, calculated as sodium sulphate, shall not exceed 0,25 % when tested In accordance with ISO 9198, using a hot extract prepared in accordance with ISO 6588-2:2005, 7.2 except that 2 ml of potassium chloride solution is not added.
4.2.7 When tested in accordance with Annex B the paper shall neither exhibit an increase in brightness due to the optical brightener of more than 1 % nor have more than five fluorescent spots, each having an axis greater than 1 mm per 0,01 m?.
4.2.8 The internal tearing resistance of the conditioned paper shall be not less than 550 mN in both machine and cross direction when tested in accordance with EN 21974.
4.2.9 The air permeance of the conditioned paper shall be not less than 3,4 .im/Pa s at an air pressure of
1.47 kPa when tested in accordance with ISO 5636-3.
4.2.10 The bursting strength of the conditioned paper shall be not less than 230 kPa when tested in accordance with EN ISO 2758.EN 868-3-2009 pdf download.