EUROLAB laboratory provides testing and compliance services within the scope of EN 868-2 standard. This standard defines test methods and values for materials for sterile barrier systems and/or packaging systems that are intended to maintain the sterility of ultimately sterilized medical devices up to the point of use. The need for protective packaging can be determined by the manufacturer and the user.
This part of EN 868 only presents the performance requirements and test methods specific to the products covered by this part of EN 868, but does not add or replace the general requirements set out in EN ISO 11607-1. Therefore, specific requirements can be used to demonstrate compliance with one or more, if not all, of the requirements in EN ISO 11607-1.
For medical devices sterilized as terminals, the packaging must be designed and manufactured so that the medical device can be sterilized and remain sterile under storage and transport conditions until the sterile barrier system is damaged or opened. One of the most critical features of a sterile barrier system and packaging system for sterile medical devices is the assurance of sterility care. Medical devices delivered sterile must be manufactured, packaged and sterilized by validated methods.
When additional materials are used within the sterile barrier system to facilitate organization, drying, or aseptic presentation (e.g., inner wrap, container filter, gauges, packing lists, mats, instrument organizer kits, tray liners, or an additional envelope around the medical device) then validation Other requirements may apply, including determining the acceptability of these materials during their operations.
This standard specifies examples of specific specifications and test methods for suitable sterilization packaging used as packaging for medical devices to be sterilized at the end.
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