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