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This document specifies test methods and values for single-use paper bags manufactured from paper specified in EN 868-3, used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
This document specifies test methods and values for paper used in the manufacture of single-use paper bags (specified in EN 868-4) and in the manufacture of single-use pouches and reels (specified in EN 868-5) used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices by means of sterilization processes that require properties specific to higher temperature sterilization, such as moist heat sterilization used in healthcare facilities. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 [2], this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
This document specifies test methods and values for sterilization wrap made of - single-use creped paper - single-use nonwoven materials - reusable woven textile materials used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
This document specifies test methods and values for sealable adhesive coated paper manufactured from paper complying with EN 868-6, used as single-use sterile barrier systems and/or single-use packaging systems for terminally sterilized medical devices by the means of low temperature sterilization processes. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 [2], this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
This document specifies test methods and values for paper used in the manufacture of single-use preformed sterile barrier systems and/or packaging systems for terminally sterilized medical devices by means of low temperature sterilization processes. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 [2], this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.