DIN EN ISO 11607-2/A11
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); German version EN ISO 11607-2:2020/A11:2022
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2: Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des Zusammenstellens (ISO 11607-2:2019); Deutsche Fassung EN ISO 11607-2:2020/A11:2022
Document: references other documents
Responsible national committee
NA 176-03-07 AA - Sterile supply
Responsible european committee
CEN/TC 102 - Sterilizers and associated equipment for processing of medical devices