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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

Standard [WITHDRAWN]

DIN EN ISO 13408-1:2013-08

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

German title
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
Publication date
2013-08
Original language
German
Pages
64

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Publication date
2013-08
Original language
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Pages
64
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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.

Content

ICS

11.080.01
Replacement amendments

This document replaces DIN EN ISO 13408-1:2011-09 .

This document has been replaced by: DIN EN ISO 13408-1:2015-12 , DIN EN ISO 13408-1:2024-09 .

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