BS EN 868-5:2009 - Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous and plastic film construction. Requirements and test methods – BSI British Standards

BS EN 868-5:2009

Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous and plastic film construction. Requirements and test methods

Status : Superseded, Withdrawn   Published : October 2009 Replaced By : BS EN 868-5:2018

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BS EN 868-5:2009 Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous and plastic film construction. Requirements and test methods

Part 1 of the BS EN 868 series of European standards specifies general requirements and test methods for all packaging materials and systems intended for use as packaging for medical devices which are to be terminally sterilized in their packaging.

BS EN 868-5 provides examples of particular requirements and test methods for heat and self-sealable pouches and reels manufactured from paper complying with EN 868-3 and plastic film complying with clause 4 of this European standard.

It introduces no additional requirements to the general requirements of Part 1 of BS EN 868, but provides guidance based upon various elements of former, relevant national standards.

As such, the particular requirements given in BS EN 868-5 can be used to demonstrate compliance with one or more but not all of the requirements of Part 1 of BS EN 868.

Heat and self-sealable pouches and reels specified in this standard are suitable for use as packaging of medical devices which are to be terminally sterilized. The use of heat and self-sealable pouches and reels as primary packages enables ease of aseptic presentation where it is important for the user to be able to see the contents of the pack before it is opened.

Contents of BS EN 868-5 contain:

  • Introduction
  • Scope
  • Normative references
  • Definitions
  • Requirements
  • Method for the determination of resistance to the sterilization process
  • Method for the determination of pinholes in plastic laminate
  • Method for the determination of peel characteristics of paper/plastic laminate products
  • Method for the determination of the strength of the heat seal joint for pouches and reel material
  • Method for the determination of fibre orientation 8
  • Dimensions and tolerances
  • Bibliography



Standard NumberBS EN 868-5:2009
TitlePackaging for terminally sterilized medical devices. Sealable pouches and reels of porous and plastic film construction. Requirements and test methods
StatusSuperseded, Withdrawn
Publication Date31 October 2009
Withdrawn Date07 January 2019
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 868-5:2018
ReplacesBS EN 868-5:1999
International RelationshipsEN 868-5:2009
Draft Superseded By07/30166933 DC
DescriptorsPaper products, Packaging, Heat-sealing, Peeling tests, Composite materials, Plastic films, Medical equipment, Performance testing, Mechanical testing, Plastics, Containers, Strength of materials, Medical instruments, Performance, Holes, Joints, Drums (materials handling equipment), Fibres, Sterilization (hygiene), Sterile equipment, Paper, Stain tests, Marking, Packaging materials, Visual inspection (testing)
ICS11.080.30
55.040
55.080
Title in FrenchMatériaux d'emballage pour les dispositifs médicaux stérilisés au stade terminal. Sachets et gaines thermoscellables constitués d'une face matière poreuse et d'une face film plastique. Exigences et méthodes d'essai
Title in GermanVerpackungen für in der Endverpackung zu sterilisierende Medizinprodukte. Siegelfähige Klarsichtbeutel und -schläuche aus porösem Material und Kunststoff-Verbundfolie. Anforderungen und Prüfverfahren
CommitteeCH/198
ISBN978 0 580 55005 8
PublisherBSI
FormatA4
DeliveryYes
Pages22
File Size333 KB
Price£130.00


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