BS EN 868-4:2009 - Packaging for terminally sterilized medical devices. Paper bags. Requirements and test methods – BSI British Standards

BS EN 868-4:2009

Packaging for terminally sterilized medical devices. Paper bags. Requirements and test methods

Status : Revised, Superseded, Withdrawn   Published : October 2009 Replaced By : BS EN 868-4:2017

WITHDRAWN TITLE
*To ask about withdrawn titles contact the
BSI Customer Services
cservices@bsigroup.com, +44 345 086 9001


BS EN 868-4:2009 Packaging for terminally sterilized medical devices. Paper bags. Requirements and test methods

BS EN 868 Part 4 provides test methods and values for paper bags manufactured from paper specified in Part 3 of BS EN 868, 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.

BS EN 868-4 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 BS EN ISO 11607-1.

As such, the particular requirements in BS EN 868-4 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1.

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

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 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.

Every sterile barrier system shall fulfil the requirements of BS EN ISO11607-1.

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.

Contents of BS EN 868-4 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 ph value, chloride and sulphate in paper bags
  • Method for the determination of the tensile strength of the back seam joint
    in paper bags
  • Bibliography

BS EN 868-4:2009 replaces BS EN 868-4:1999, which has been withdrawn.




Standard NumberBS EN 868-4:2009
TitlePackaging for terminally sterilized medical devices. Paper bags. 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 868-4:2017
ReplacesBS EN 868-4:1999
International RelationshipsEN 868-4:2009
Draft Superseded By07/30166930 DC
DescriptorsPackaging materials, Packaging, Medical equipment, Medical instruments, Sterilization (hygiene), Sterile equipment, Wrapping, Bags, Paper products, Design, Seals, Marking, Signal devices, Heat-sealing, Strips, Performance, Instructions for use, pH measurement, Chemical analysis and testing, Determination of content, Chlorides, Sulfates, Tensile strength, Performance testing
ICS11.080.30
55.040
55.080
Title in FrenchMatériaux d'emballage pour les dispositifs médicaux stérilisés au stade terminal. Sacs en papier. Exigences et méthodes d'essai
Title in GermanVerpackungen für in der Endverpackung zu sterilisierende Medizinprodukte. Papierbeutel. Anforderungen und Prüfverfahren
CommitteeCH/198
ISBN978 0 580 54956 4
PublisherBSI
FormatA4
DeliveryNo
Pages16
File Size1.419 MB
Price£130.00


WITHDRAWN TITLE
*To ask about withdrawn titles contact the
BSI Customer Services
cservices@bsigroup.com, +44 345 086 9001
 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


Collaborate, Innovate, Accelerate.


BSOL

The faster, easier way to work with standards


Worldwide Standards
We can source any standard from anywhere in the world


Customers who bought this product also bought

  • BS EN 556-1:2001
    Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" Requirements for terminally sterilized medical devices