(812) 309-78-59
(495) 223-46-76
IEC 60601-2-65:2012+AMD1:2017 CSV ed1.1
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
184 стр.
Действует
Печатная копияЭлектронный (pdf)
573.30 CHF (включая НДС 20%)
Разработчик:
Зарубежные/IEC
ICS:
11.040.55 Diagnostic. Including medical monitoring equipment, medical thermometers and related materials / Диагностическое оборудование. Включая медицинскую контрольную аппаратуру, медицинские термометры и связанные с ними материалы
Описание
IEC 60601-2-65:2012+A1:2017 applies to the basic safety and essential performance of dental intra-oral X-ray equipment and its main components. The scope of this standard is restricted to X-ray equipment where the X-ray tube assembly contains the high-voltage transformer assembly. Dental extra-oral X-ray equipment is excluded from the scope of this standard. This particular standard has been prepared to provide, based on IEC 60601-1:2005 and its collaterals, a complete set of basic safety and essential performance requirements for dental intra-oral X-ray equipment. While the previously existing standards for such equipment were dedicated to components and subsystems, this particular standard addresses the system level of dental intra-oral X-ray equipment. Components and their functions are addressed as far as necessary. This consolidated version consists of the first edition (2012) and its amendment 1 (2017). Therefore, no need to order amendment in addition to this publication.