DIN Standards Committee Health Technologies
DIN EN ISO 11607-2
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006 + Amd 1:2014); German version EN ISO 11607-2:2006 + A1:2014
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2: Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des Zusammenstellens (ISO 11607-2:2006 + Amd 1:2014); Deutsche Fassung EN ISO 11607-2:2006 + A1:2014
Overview
This document contains the amendment to EN ISO 11607-2:2006, which has been prepared by ISO/TC 198 "Sterilization of health care products" (secretariat: ANSI, USA) in collaboration with CEN/TC 102 "Sterilization of medical devices" (secretariat: DIN, Germany). The responsible German committee is NA 063-04-04 AA "Sterilgutversorgung" ("Sterile supply") at the Medical Standards Committee (NAMed) at DIN, the German Institute for Standardization e. V. The modifications are primarily of editorial nature, that is, mostly references have been updated.
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 176-03-07 AA - Sterile supply