Standard [CURRENT]
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With the new edition of International Standard ISO 15883-1:2006, gaps indicated in Annex ZA regarding essential requirements of EC Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directives 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices and 93/42/EEC on medical devices and EU Directive 98/8/EC on the placing on the market of biocidal products were partly closed. The European Standards have been prepared by CEN/TC 102 "Sterilizers for medical purposes", the secretariat of which is held by DIN. The responsible committee is NA 063-04-09 AA "Reinigungs-Desinfektionsgeräte" ("Washer disinfectors") at NAMed.
This document replaces DIN EN ISO 15883-1:2009-09 .