BS EN 868-3:2009 - 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 – BSI British

BS EN 868-3:2009

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

Status : Revised, Superseded, Withdrawn   Published : October 2009 Replaced By : BS EN 868-3:2017

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BS EN 868-3:2009 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

Every sterile barrier system should fulfil the requirements of BS EN ISO 11607-1. The BS EN ISO 11607 series consists of two parts under the general title "Packaging for terminally sterilized medical devices". Part 1 of this series specifies general requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. Part 2 of this series specifies validation requirements for forming, sealing and assembly processes.

The BS EN 868 series can be used to demonstrate compliance with one or more of the requirements specified in BS EN ISO 11607-1.

BS EN 868-3 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 BS EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of BS EN 868 but does not add or modify the general requirements specified in BS EN ISO 11607-1.

As such, the particular requirements specified can be used to demonstrate compliance with one or more but not all of the requirements of BS 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 BS EN 868 are intended for single use only.

Applicable sterilization methods are specified by the manufacturer.

Contents of BS EN 868-3 contain:

  • Scope
  • Normative references
  • Terms and definitions
  • Requirements
  • Information to be supplied by the manufacturer 􀀃
  • Details of significant technical changes between this European Standard and the previous edition
  • Method for the determination of fluorescence
  • Method for the determination of water repellency􀀃
  • Method for the determination of pore size
  • Bibliography



Standard NumberBS EN 868-3:2009
TitlePackaging 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
StatusRevised, Superseded, Withdrawn
Publication Date31 October 2009
Withdrawn Date28 February 2017
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Replaced ByBS EN 868-3:2017
ReplacesBS EN 868-3:1999
International RelationshipsEN 868-3:2009
Draft Superseded By07/30166927 DC
DescriptorsPackaging materials, Packaging, Medical equipment, Medical instruments, Sterilization (hygiene), Sterile equipment, Paper, Paper bags, Paper products, Drums (materials handling equipment), Containers, Performance, Performance testing, Weight tolerances, pH, Determination of content, Optical properties of materials, Tear strength, Tensile strength, Air permeability, Water-resistance tests, Marking, Porosity measurement, Porosity, Fluorescence
ICS11.080.30
55.040
Title in FrenchMatériaux d'emballage pour les dispositifs médicaux stérilisés au stade terminal. Papier utilisé dans la fabrication de sacs en papier (spécifiés dans l'EN 868-4) et dans la fabrication de sachets et gaines (spécifiés dans l'EN 868-5). Exigences et méthodes d'essai
Title in GermanVerpackungen für in der Endverpackung zu sterilisierende Medizinprodukte. Papier zur Herstellung von Papierbeuteln (festgelegt in EN 868-4) und zur Herstellung von Klarsichtbeuteln und -schläuchen (festgelegt in EN 868-5). Anforderungen und Prüfverfahren
CommitteeCH/198
ISBN978 0 580 54955 7
PublisherBSI
FormatA4
DeliveryNo
Pages20
File Size344.8 KB
Price£130.00


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