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DIN Standards Committee Health Technologies

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Standards [Withdrawn]

DIN EN ISO 13408-1
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008 + Amd 1:2013); German version EN ISO 13408-1:2011 + A1:2013

Title (German)

Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 1: Allgemeine Anforderungen (ISO 13408-1:2008 + Amd 1:2013); Deutsche Fassung EN ISO 13408-1:2011 + A1:2013

Overview

This amendment (EN ISO 13408-1:2011 + A1:2013) has been prepared by Technical Committee ISO/TC 198 "Sterilization of health care products" in collaboration with Technical Committee CEN/TC 204 "Sterilization of medical devices". The responsible German committee is Working Committee NA 063-01-12 AA "Aseptische Herstellung" ("Aseptic processing") of the Medical Standards Committee, NAMed. The amendment primarily concerns a revision of Figure A.1 in Annex A relating to requirements for cleanroom conditions for fitting caps as well as an update of the normative references.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-03-10 AA - Aseptic processing  

Responsible european committee

CEN/TC 204 - Sterilization of medical devices  

Responsible international committee

ISO/TC 198/WG 9 - Aseptic processing  

Edition 2013-08
Original language German
Translation English
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Table of contents

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Dipl.-Ing. (FH)

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