DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 60601-2-65
; VDE 0750-2-65:2016-11
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment (IEC 60601-2-65:2012); German version EN 60601-2-65:2013
Medizinische elektrische Geräte - Teil 2-65: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von intraoralen zahnärztlichen Röntgeneinrichtungen (IEC 60601-2-65:2012); Deutsche Fassung EN 60601-2-65:2013
Overview
These particular requirements amend and supplement the basic standard DIN EN 60601-1 (VDE 0750-1):2007-07. They apply to the basic safety and essential performance of dental intraoral X-ray equipment. Within their specific scope, the clauses of these particular requirements replace those in DIN EN 60601-2-7 "Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators". Some of the particular requirements for dental X-ray equipment specified in the supplementary standard DIN EN 60601-1-3 or in the particular requirements DIN EN 60601-2-28, DIN EN 60601-2-7 or DIN EN 60601-2-32 have been "extracted" and inserted into the present particular requirements. Requirements for extraoral dental X-ray equipment are specified in the particular requirements IEC 60601-2-63. Joint Working Committee NA 080-00-16 GA "Bildgebende Systeme" ("Imaging systems") of DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE (www.dke.de) and DIN Standards Committee Radiology (NAR) in collaboration with Deutsche Röntgengesellschaft (German Radiological Society) is responsible for this standard.
Document: references other documents
Responsible national committee
DKE/GK 813 - Elektrische und mechanische Sicherheit in der radiologischen Technik
