EN 868-5-2009 pdf download.Packaging for terminally sterilized medical devices – Part 5:Sealable pouches and reels of porous materials and plastic film construction – Requirements and test methods.
This part of EN 868 provides test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2. 3. 6, 7. 9 or 10 and plastic film complying with Clause 4 used as sterile bamer systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.
NOTE 1 The need r a protective padcagfng 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 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1.
The materials specified In this part of EN 868 are intended for single use only.
NOTE 2 When addibonal matenals are used inside the stente bamer system in order to ease the organization, drying or asept presentation (e.g. inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional env&ope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities. may app’y.
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 868-2. Packaging for terminally sterilized medical devices — Part 2: Sterilization wrap — Requirements and test methods
EN 868-3. 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
EN 868-6. Packaging for terminally sterilized medical devices — Part 6: Paper for low temperature sterilization process — Requirements and test methods
EN 868-7. Packaging for terminally sterilized medical devices — Part 7: Adhesive coated paper far low temperature sterilization processes — Requirements and test methods
EN 868-9. Packaging (or terminally sterilized medical devices — Part 9: Uncoated nonwoven materials of pal yolef ines — Requirements and test methods
EN 868-10, Packaging for terminally sterilized medical devices — Part 10: Adhesive coated nonwoven materials of polyolefines — Requirements and test methods
EN ISO 11140-1, Sterilization of health care products — Chemical indicators — Part 1: General requirements (ISO 11140-1:2005)
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 8601. Data elements and interchange formats — Information interchange — Representation of dates and times
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EN 868-5:2009 (E)
ASTM D 882:1995. Test Methods for Tensile Properties of the Thin Plastic Sheeting
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2006 and the following apply.
3.1
healthcare facility
location wtere patients are medically treated andlor medical devices are terminally sterilized
EXAMPLE Hospital, dentist office, practitioner.
4 Requirements
4.1 General
The requirements of EN ISO 11607-1 apply.
NOTE 1 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. bioburden if applicable).
NOTE 2 For validation requirements for forming, sealing and assembly processes, see EN ISO 11607-2.
42 Materials
4.2.1 Porous material
The porous material shall comply with the requirements of either EN 868 part 2. 3, 6, 7. 9 or 10.
When the porous material is to be used to manufacture preformed sterile barrier systems intended to be
irradiation sterilized only, requirements for wet strength properties or permeability to air need not apply.
4.2.2 Plastic film
4.2.2.1 The plastic film shall be a composite of two or more layers. When tested after the intended sterilization process in accordance with Annex B the plastics interply bond shall not separate nor become cloudy.
4.2.2.2 The plastic film shall be free from pinholes when tested in accordance with Annex C.
4.2.2.3 When examined by unaided normal or corrected vision in transmitted light (daylight or good artificial light) the plastic film shall be free from foreign matter and/or other imperfections that would adversely affect compliance with the requirements of 4.5.
NOTE Slight continuous surface irregularities ansing from the extrusion of the plastic film is not regarded as a defect.
4.2.2.4 The plastic film shall be sealable to the porous material under the conditions specified by the manufacturer (see Clause 5. NOTE 1).
4.2.2.5 The breaking factor of the plastics film shall be not less than 20 N per 15 mm width when tested in accordance with ASTM 0882:1995 (Method A).EN 868-5-2009 pdf download.
EN 868-5-2009 pdf download
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