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This consolidated version of DIN EN 13795 takes into account the essential requirements of the EC Directive 93/42/EEC on medical devices in the form currently required by the EU Commission. With respect to the previous edition from 2011, only Annex ZA was updated correspondingly. This document has been prepared by CEN/TC 205 "Non-active medical devices", the secretariat of which is held by DIN (Germany). The responsible German committee is NA 063-01-08 GA "Operationstextilien" ("Surgical textiles") at the Medical Standards Committee and the Textiles and Textile Machinery Standards Committee.
This document replaces DIN EN 13795:2011-06 .
This document has been replaced by: DIN EN 13795-1:2019-06 , DIN EN 13795-2:2019-06 .