EN 60601-2-28

Area	Medical technology
title	Medical electrical equipment - Part 2-28: Particular requirements for the safety including the essential performance characteristics of X-ray tubes for medical diagnostics
Latest edition	2010-11
ISO	-

The EN 60601-2-28 titled "Medical electrical equipment - Part 2-28: Particular requirements for the safety of X-ray tube including aperture system and X-ray tube assemblies for medical diagnosis" is part of the series of standards EN 60601 .

The German Institute for Standardization is the publisher of the DIN standard DIN EN 60601-2-28 .

The standard is based on the international version IEC 60601-2-28. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-28 , see DIN-VDE standards part 7 .

This supplementary standard regulates general specifications for the safety, tests and guidelines of X-ray tubes and their blend systems.

validity

The German edition November 2011 has been accepted as a German standard from the date of its publication .

scope of application

This standard applies to X-ray tubes and to X-ray tubes, including a blend system for medical diagnostics and their components, which are intended for use in medical X -ray equipment, including computer tomography, which contain an application-specific X-ray generator in accordance with EN 60601-2-7 or EN 60601-2-15 .

extra information

The following changed requirements are contained in 60601-2-28 (extract):

Protection against electric shock
Reference to compliance with EN 60601-1-3 (radiation protection)
Temperature hazards
Danger from pressurized parts
Accuracy of the operating data (reference to EN 60601-2-7 and EN 60601-2-15 )