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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.
This document replaces DIN EN ISO 13408-1:2011-09 .
This document has been replaced by: DIN EN ISO 13408-1:2015-12 .