DIN Standards Committee Quality Management, Statistics and Certification
DIN EN ISO 15883-1
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006 + Amd 1:2014); German version EN ISO 15883-1:2009 + A1:2014
Reinigungs-Desinfektionsgeräte - Teil 1: Allgemeine Anforderungen, Begriffe und Prüfverfahren (ISO 15883-1:2006 + Amd 1:2014); Deutsche Fassung EN ISO 15883-1:2009 + A1:2014
Overview
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.
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 176-03-01 AA - Washer-disinfectors
