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This standard (EN 1041:2008+A1:2013) contains the amendments to EN 1041:2008 which have been prepared by Technical Committee CEN/CLC/TC 3 "Quality management and corresponding general aspects for medical devices". The responsible German committee is NA 063-01-13 AA "Qualitätsmanagement und entsprechende allgemeine Aspekte für Medizinprodukte" ("Quality management and corresponding general aspects for medical devices") at the Medical Standards Committee, NAMed. The amendment mainly contains specifications regarding the provision of information required in clause 5, and an update of the Bibliography.
This document replaces DIN EN 1041:2008-11 .
This document has been replaced by: DIN EN ISO 20417:2021-12 .