Standard [WITHDRAWN]
DIN EN ISO 11607-1:2014-11
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
- German title
- 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
- Publication date
- 2014-11
- Original language
- German
- Pages
- 45
- Publication date
- 2014-11
- Original language
- German
- Pages
- 45
Product information on this site:
Quick delivery via download or delivery service
All transactions are encrypted
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.
This document replaces DIN EN ISO 11607-1:2009-09 .
This document has been replaced by: DIN EN ISO 11607-1:2020-05 , DIN EN ISO 11607-1:2017-10 .
This document has been corrected by: DIN EN ISO 11607-1 Berichtigung 1:2016-09 .