What is BS 6256 about?
BS 6256 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.
BS 6256 details a test method that can’t be found elsewhere and that can be used to demonstrate conformity with ISO 11607-1.
Who is BS 6256 for?
BS 6256 on requirements for terminally-sterilized medical devices packaging are beneficial to:
- Manufacturers of sterile medical devices
- Manufacturers of packaging materials and packaging systems for sterile devices
- Regulatory authorities
- Healthcare providers
Why should you use BS 6256?
The process of designing and developing a packaging system for terminally sterilized medical devices is a complicated and critical endeavor. The device components and the packaging system need to be combined to create a product that performs efficiently, safely, and effectively in the hands of the user.
Through BS 6256, recommendations provide users with physical protection, maintain sterility up to the point of use and allow aseptic presentation. The specific nature of the medical device, intended sterilization methods, intended use, expiry date, transport, and storage all influence the packaging system design and choice of materials.
As a buyer of BS 6256 the sterile barrier system achieved will be essential to ensure the safety of terminally sterilized medical devices. Regulatory authorities recognize the critical nature of sterile barrier systems by considering them as an accessory or a component of a medical device.
Keeping this in mind, BS 6256 ensures optimum quality and performance of medical devices allowing healthcare providers to deliver safe and effective products and services to the end-user. Moreover, conformity with international standards will foster confidence and reliability for your products.
What is changed since the last update?
BS 6256:2021 supersedes BS 6256:1989, which is withdrawn. BS 6256:2021 currently has three key changes:
- Some of the requirements in the 1989 standard have been superseded by the BS EN ISO 11607 series and the BS EN 868 series, so this content has been removed
- Annex C of the 1989 standard referenced two withdrawn British Standards (BS 2577:1955and BS 3431:1961). The necessary content in these standards has been transferred into BS 6256
- The test method for determining the penetration of methylene blue particles in packing materials has been transferred from Annex C to the main body of BS 6256
