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DIN Standards Committee Health Technologies

Overview

This standard has been prepared by CEN/TC 102 "Sterilizers for medical purposes" (secretariat: DIN, Germany). Working Committee NA 063-04-04 AA "Sterilgutversorgung" ("Sterile supply") of DIN Standards Committee Medicine (NAMed) at the German Institute for Standardization e. V. is responsible for this standard. This part of EN 868 provides test methods and values for paper bags manufactured from paper specified in Part 3 of EN 868-3, 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 EN 868 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 EN ISO 11607-1.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-03-07 AA - Sterile supply  

Responsible european committee

CEN/TC 102/WG 4 - Packaging