DIN EN 60601-1-3:2014-06

This standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems. It is a collateral standard to IEC 60601-1:2005 + A1/2012 and applies to x-ray equipment and to subassemblies of such equipment, where radiological images of a human patient are used for diagnosis, planning or guidance of medical procedures. Basically, the references have been adjusted to the amendment of IEC 60601-1:2005. The requirements in this collateral standard concern protective measures to be taken by the manufacturers in the design and construction of medical diagnostic x-ray equipment and its subassemblies. The consolidated version of the second edition of this collateral standard is focused on general requirements for radiation protection. It includes those requirements that apply to all diagnostic x-ray equipment. The international document has been prepared by Subcommittee SC 62B "Diagnostic x-ray imaging equipment" of the International Electrotechnical Commission (IEC) with German collaboration. The responsible body is NA 080-00-12 Joint Working Committee NAR/DKE "Strahlenschutz" ("Radiation protection") of DIN Standards Committee Radiology (NAR) at DIN e. V., the German Institute for Standardisation, in cooperation with the German Radiology Society.