The International Electrotechnical Commission (IEC) has released IEC 60601-2-65:2012+A1:2017 for Medical electrical equipment. This amendment details particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment. This standard is now available on the IEC webstore.
Description: “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.”
*Description from the IEC Website.
