Every sterile barrier system should fulfil the requirements of BS EN ISO 11607-1. 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.
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.
BS EN 868-3 provides test methods and values for paper, used in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) 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.
This part of BS EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of BS EN 868 but does not add or modify the general requirements specified in BS EN ISO 11607-1.
As such, the particular requirements specified can be used to demonstrate compliance with one or more but not all of the requirements of BS EN ISO 11607-1.
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 materials specified in this part of BS EN 868 are intended for single use only.
Applicable sterilization methods are specified by the manufacturer.
Contents of BS EN 868-3 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 fluorescence
- Method for the determination of water repellency
- Method for the determination of pore size
- Bibliography
