Standard [WITHDRAWN]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
- Publication date
- 2013-08
- Original language
- German
- 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
This document replaces DIN EN ISO 13408-1:2011-09 .
This document has been replaced by: DIN EN ISO 13408-1:2015-12 .