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Standards [Withdrawn]

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

Title (German)

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  

Responsible european committee

CEN/TC 102/WG 4 - Packaging  

Responsible international committee

ISO/TC 198 - Sterilization of health care products  

Edition 2014-11
Original language German
Translation English
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Table of contents

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