BS EN 868 Part 6 provides test methods and values for paper used in the manufacture of preformed 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.
BS EN 868-6 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add or modify the general requirements specified in BS EN ISO 11607-1.
As such, the particular requirements in BS EN 868-6 can be used to demonstrate compliance with one or more but not all of the requirements of BS EN ISO 11607-1.
Paper specified in this part of the series EN 868 is intended for use in part or complete manufacture of pouches and form and fill packs and lidding material for packs.
The paper specified in this part of the series EN 868 is suitable for the manufacture of sterile barrier systems to be used in ethylene oxide, irradiation or low temperature steam formaldehyde sterilization processes and to produce coated paper according to EN 868-7.
Paper according to BS EN 868-3 can also be used for these sterilization processes.
The materials specified in this part of BSEN868 are intended for single use only.
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 filters, 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 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.
BS EN 868-2 of this series specifies validation requirements for forming, sealing and assembly processes.
Every sterile barrier system shall fulfil the requirements of BS EN ISO 11607-1.
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.
Contents of BS EN 868-6 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
BS EN 868-6:2009 replaces BS EN 868-6:1999, which has been withdrawn
