BS EN 868-5:2018 - TC Tracked Changes. Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods

BS EN 868-5:2018 - TC

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

Status : Current   Published : August 2019

Format
PDF



What is a tracked changes standard?

A tracked changes version of a Standard indicates the changes made, during the standards revision process, between the active standard and its previous version. Additions, deletions, and other formatting and/or content revisions are clearly displayed as underlined and strikethrough texts, ensuring all changes made between the two documents are quickly and easily identified. This version of the standard includes both a copy of the new standard, along with a track changes version.

What is this standard about?

This is a tracked changes document. It compares the 2009 version of BS EN 868-5 with the 2018 version, highlighting what’s changed, and also includes a full “clean” version of the 2018 standard. BS EN 868-5 is the fifth in a currently nine-part series covering requirements and test methods for terminally sterilized medical devices packaging.

Who is this standard for?

  • Healthcare facilities with in-house or contracted sterilization services
  • Manufacturers of medical devices, including IVDs, particularly suppliers of systems and procedure packs and reprocessing reusable surgical instruments
  • Manufacturers of packaging materials and packaging systems for sterile devices

Why should you use this standard?

The BS EN 868 series will help medical device manufacturers and hospital users identify materials for sterile barrier systems, and purchase materials and products to be used for medical devices to be sterilized. This part of the standard specifically focuses on sealable pouches and reels manufactured from porous materials.

This standard also helps users working with sealable pouches and reels manufactured from porous materials to demonstrate compliance with one or more of the general requirements provided in BS EN ISO 11607-1 and the EU regulations concerning medical devices.

It specifies test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10, and plastic film complying with Clause 4. These sealable pouches and reels are 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.

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

What’s changed since the last update?

The main changes highlighted in this document are:

a)Updates to the normative references

b) An additional reference to an applicable standard published by ASTM

c) Alignment of this document with the BS EN ISO 11607 series by: 

  i) Incorporating the requirements of BS EN ISO 11607‑1 through a normative reference 

 ii)Aligning the requirements with BS EN ISO 11607‑1

d) Clarification of performance and marking requirements

e) Amends to the test methods for the determination of the strength of the seal for pouches and reel material

f) Amends to the test method for the determination of peel characteristics of paper/plastic laminate products

g) Updates to the bibliography

 




Standard NumberBS EN 868-5:2018 - TC
TitleTracked Changes. Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods
StatusCurrent
Publication Date01 August 2019
Normative References(Required to achieve compliance to this standard)ASTM F88/F88M - 15, BS EN 868-10:2018, BS EN 868-9:2018, ISO 11607-1:2006, EN 868-6:2017, EN ISO 11140-1, ISO 8601, EN ISO 11607-1:2017, ISO 11140-1, ASTM D882 - 12, EN 868-10:2018, ISO 11607-1:2006/Amd 1:2014, EN 868-3:2017, EN 868-2:2017, EN 868-9:2018, EN 868-7:2017
Informative References(Provided for Information)EN 1041, ISO 11607-2, EN 14180, EN 13060, EN 285, EN 1422, EN ISO 11607-2, EN ISO 14937, ISO 14937, EN ISO 15223-1:2016, ISO 15223-1:2016
DescriptorsStrength of materials, Medical instruments, Medical equipment, Heat-sealing, Performance, Packaging materials, Peeling tests, Stain tests, Packaging, Paper products, Composite materials, Plastics, Holes, Mechanical testing, Sterilization (hygiene), Performance testing, Sterile equipment, Paper, Marking, Joints, Visual inspection (testing), Plastic films, Containers, Drums (materials handling equipment), Fibres
ICS11.080.30
55.040
55.080
Title in FrenchEmballages des dispositifs médicaux stérilisés au stade terminal Sachets et gaines scellables 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 porösen Materialien und Kunststoff-Verbundfolie. Anforderungen und Prüfverfahren
CommitteeCH/198
ISBN978 0 539 05861 1
PublisherBSI
FormatA4
DeliveryYes
Pages50
File Size1.194 MB
Price£229.00


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