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  • BSI
    BS EN 868-2:2017 Packaging for terminally sterilized medical devices - Sterilization wrap. Requirements and test methods
    Edition: 2017
    $411.69
    / user per year

Description of BS EN 868-2:2017 2017

This draft European Standard provides test methods and values for materials for 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 4.2.2.1 to 4.2.2.3 of this part of EN 868 are intended for single use, the materials specified in 4.2.2.4 are intended for reuse.

Standard NumberBS EN 868-2:2017
TitlePackaging for terminally sterilized medical devices - Sterilization wrap. Requirements and test methods
StatusUnder Review
Publication Date2017-02-28
ReplacesBS EN 868-2:2009
Identical National Standard OfEN 868-2:2017
DescriptorsTear strength, Air permeability, Drape determination (textiles), Marking, Optical properties of materials, Packaging, Woven fabrics, Water-resistance tests, Crepe paper, pH, Medical instruments, Porosity, Performance, Tensile strength, Sterile equipment, Porosity measurement, Paper, Weight (mass), Packaging materials, Wrapping paper, Elongation at fracture, Medical equipment, Sterilization (hygiene)
ICS55.040 Packaging materials and accessories, 11.080.30 Sterilized packaging
CommitteeCH/198
ISBN978 0 580 90656 5
PublisherBSI
Pages28

The following editions for this book are also available...

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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