DIN EN ISO 11607-1
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006 + Amd 1:2014); German version EN ISO 11607-1:2009 + A1:2014
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1: Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO 11607-1:2006 + Amd 1:2014); Deutsche Fassung EN ISO 11607-1:2009 + A1:2014
Overview
This document contains the amendment to EN ISO 11607-1:2006, 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 amendment basically incorporates clarifications in the standard text, for example additional requirements to information to be provided by the manufacturer whereby many reported gaps in European Annex ZA could be closed. Furthermore, Annex B, including a list of test methods and procedures, has been updated and restructured.
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 176-03-07 AA - Sterile supply
