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Normas BSI – AENOR
BS EN 868-3:2017

BS EN 868-3:2017

Packaging for terminally sterilized medical devices. 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

Fecha:
2017-02-28 /Definitive
Comité:
CH/198
Equivalencias internacionales:

EN 868-3:2017

Relación con otras normas BSI:

Reemplaza a: BS EN 868-3:2009

Resumen:
This draft European Standard 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 and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. 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 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. NOTE Applicable sterilization methods are specified by the manufacturer.
Keywords:
Porosity measurement, Performance testing, Marking, Fluorescence, Medical instruments, Tensile strength, Air permeability, Tear strength, Drums (materials handling equipment), Paper bags, Paper, Medical equipment, Optical properties of materials, Packaging, Performance, Packaging materials, Determination of content, pH, Water-resistance tests, Sterilization (hygiene), Weight tolerances, Containers, Sterile equipment, Porosity, Paper products
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