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Normas BSI – AENOR
BS EN 868-7:2017

BS EN 868-7:2017

Packaging for terminally sterilized medical devices. Adhesive coated paper for low temperature sterilization processes. Requirements and test methods

2017-02-28 /Definitive
Equivalencias internacionales:

EN 868-7:2017

Relación con otras normas BSI:

Reemplaza a: BS EN 868-7:2009

This draft European Standard provides test methods and values for sealable adhesive coated paper manufactured from paper complying with EN 868-6, used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. The materials specified in this part are intended to be used for ethylene oxide or irradiation sterilization. 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. 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.
Wrapping, Instructions for use, Low temperatures, Adhesion tests, Heat-sealing, Visual inspection (testing), Adhesive paper, Strength of materials, Ethylene oxide, Paper, Weight measurement, Water-resistance tests, Packaging materials, Medical instruments, Sterile equipment, Packaging, Medical equipment, Mass, Marking, Coatings, Adhesives, Porosity measurement, Fluorescence, Waterproof materials, Packages, Tensile strength, Performance, Determination of content, Chemical analysis and testing, Sterilization (hygiene), pH, Radiation
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