BS EN 868-9:2018 Packaging for terminally sterilized medical devices. Uncoated nonwoven materials of polyolefines. Requirements and test methods

BS EN 868-9:2018

Packaging for terminally sterilized medical devices. Uncoated nonwoven materials of polyolefines. Requirements and test methods

Status : Current   Published : January 2019

Format
PDF

Format
HARDCOPY



What is this standard about?

This document specifies test methods and values for uncoated nonwoven materials of polyolefines 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.

Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.

The materials specified in this part of EN 868 are intended for single use only.




Standard NumberBS EN 868-9:2018
TitlePackaging for terminally sterilized medical devices. Uncoated nonwoven materials of polyolefines. Requirements and test methods
StatusCurrent
Publication Date09 January 2019
Normative References(Required to achieve compliance to this standard)EN ISO 536, EN ISO 11607-1:2017, EN ISO 1974, ASTM D 2724, ISO 5636-3, ISO 2758, ISO 536, EN ISO 2758, EN ISO 811, ISO 811, EN ISO 1924-2, ISO 8601, ISO 1924-2, ISO 1974, ISO 6588-2, ISO 11607-1:2006/Amd 1:2014, ISO 11607-1:2006
Informative References(Provided for Information)EN ISO 10993-1, ISO 10993-1, ISO 11607-2, EN ISO 11607-2
ReplacesBS EN 868-9:2009
International RelationshipsEN 868-9:2018
Draft Superseded By17/30360918 DC
DescriptorsPolyolefins, Strength of materials, Sterilization (hygiene), Packaging, Polyolefin fibres, Sterile equipment, Medical equipment, Packaging materials, Medical instruments, Heat-sealing materials
ICS11.080.30
55.040
Title in FrenchEmballages des dispositifs médicaux stérilisés au stade terminal Matériaux non tissés à base de polyoléfines, non enduits. Exigences et méthodes d'essai
Title in GermanVerpackungen für in der Endverpackung zu sterilisierende Medizinprodukte Unbeschichtete Faservliesmaterialien aus Polyolefinen. Anforderungen und Prüfverfahren
CommitteeCH/198
ISBN978 0 580 98601 7
PublisherBSI
FormatA4
DeliveryYes
Pages12
File Size647 KB
Price£110.00


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