Standard Swedish standard · SS-EN 868-10:2009

Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods

Status: Withdrawn

· Replaced by: SS-EN 868-10:2019
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Standard Swedish standard · SS-EN 868-10:2009

Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
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Scope
This part of EN 868 provides test methods and values for sealable adhesive coated nonwoven materials of polyolefines, manufactured from nonwovens complying with EN 868-9 used for sterile barrier 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 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 nor 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. NOTE 2 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.

Subjects

Sterilized packaging (11.080.30) Packaging materials and accessories (55.040)


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Standard Swedish standard · SS-EN 868-10:2009

Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
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Price: 875 SEK
standard ikon pdf

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Price: 875 SEK
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Paper

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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-69921

Edition: 2

Approved: 5/28/2009

No of pages: 24

Replaces: SS-EN 868-10

Replaced by: SS-EN 868-10:2019