Packaging for terminally sterilized medical devices - Paper for low temperature sterilization processes. Requirements and test methods Ingestion-build-47553 Clause 4 gives information on

Clause 4 gives information on competence

BS EN 116000-3 is the basis for qualification approval within the CECC quality assessment system in accordance with CECC 00114

— rules for maintenance of protection systems

transport and to check if the products are adulterated

Turbidity measured by the second method is expressed in formazin attenuation units (FAU)

Packaging for terminally sterilized medical devices - Paper for low temperature sterilization processes. Requirements and test methods Ingestion-build-47553 Clause 4 gives information on1 Scope This European Standard specifies 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. 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