BS 6256:2021 Packaging for terminally-sterilized medical devices – Method for determination of methylene blue particulate penetration

BS 6256:2021

Packaging for terminally-sterilized medical devices. Method for determination of methylene blue particulate penetration

Status : Current   Published : January 2021

Format
PDF

Format
HARDCOPY



What is BS 6256:2021 about?

Requirements for terminally-sterilized medical devices packaging are covered in an international standard, BS EN ISO 11607-1, which also lists test methods and procedures that can be used to demonstrate compliance with the requirements. BS 6256:2021 is the only available standard that describes one of these listed test methods, namely the methylene blue particulate penetration test for microbial barriers.

Who is BS 6256:2021 for?

  • Manufacturers of sterile medical devices
  • Manufacturers of packaging materials and packaging systems for sterile devices
  • Regulatory authorities

What does BS 6256:2021 cover?

It describes methods of demonstrating the performance of the microbial barrier of porous material used in a sterile barrier system by penetration of particles of methylene blue.

Why should you use BS 6256:2021?

It details a test method that can’t be found elsewhere and that can be used to demonstrate conformity with BS EN ISO 11607-1. Also BS 6256:2021 has been updated to remove superseded content and ensure it’s up to date with current practice.

 BS 6256:2021 contributes to UN Sustainable Development Goal 3 on good health and well-being, Goal 6 on clean water and sanitation and Goal 9 on industry, innovation and infrastructure.

What’s new about BS 6256:2021?

This is a revision of BS 6256:1989. The standard’s been brought up to date with current practice, plus there are three key changes:

a)       Some of the requirements in the 1989 standard have been superseded by the BS EN ISO 11607 series and the BS EN 868 series, so this content has been removed

b)      Annex C of the 1989 standard referenced two withdrawn British Standards (BS 2577:1955 and BS 3431:1961). The necessary content in these standards has been transferred into BS 6256:2021.

c)       The test method for determination of methylene blue particulate penetration of packaging material has been moved from Annex C into the main body of BS 6256:2021




Standard NumberBS 6256:2021
TitlePackaging for terminally-sterilized medical devices. Method for determination of methylene blue particulate penetration
StatusCurrent
Publication Date25 January 2021
Normative References(Required to achieve compliance to this standard)BS EN 20187
Informative References(Provided for Information)BS EN ISO 11607-1:2009+A1:2014, BS 2577:1955, BS EN ISO 11607-2:2006+A1:2014
ReplacesBS 6256:1989
Draft Superseded By20/30408621 DC
DescriptorsDrums (materials handling equipment), Medical equipment, Performance, Marking, Fluorescence, Air permeability, Stain tests, Sterilization (hygiene), Tensile strength, Bags, pH, Impurities, Containers, Strength of materials, Packaging, Paper, Water-absorption tests, Sterile equipment, Steam, Test equipment, Testing conditions, Water absorption, Mass, Penetration tests, Roughness (surface)
ICS11.080.30
CommitteeCH/198
ISBN978 0 539 12512 2
PublisherBSI
FormatA4
DeliveryYes
Pages34
File Size1.487 MB
Price£218.00


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