DIN Standards Committee Health Technologies
DIN EN 868-3
Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods; German version EN 868-3:2017
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 3: Papier zur Herstellung von Papierbeuteln (festgelegt in EN 868-4) und zur Herstellung von Klarsichtbeuteln und -schläuchen (festgelegt in EN 868-5) - Anforderungen und Prüfverfahren; Deutsche Fassung EN 868-3:2017
Overview
The standard has been prepared by CEN/TC 102 "Sterilizers for medical purposes" (secretariat: DIN, Germany). At DIN, the German Institute for Standardization e. V., DIN Standards Committee Medicine (NAMed) of Working Committee NA 063-04-04 AA "Sterilgutversorgung" ("Sterile supply") was responsible for its preparation. This part of EN 868 provides test methods and values for paper, used in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) 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. 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
Responsible national committee
NA 176-03-07 AA - Sterile supply
