EN 60601-2-45

Area	Medical technology
title	Medical electrical equipment - Part 2-45: Particular requirements for the safety of X-ray mammography equipment and mammographic stereotaxic equipment
Latest edition	9.2003
ISO	IEC 60601-2-44: 2001-05

The EN 60601-2-45 with the title "Medical electrical devices - Part 2-45: Special provisions for the safety of X-ray mammography devices and mammographic stereotaxic devices" is part of the EN 60601 series of standards . The German Institute for Standardization is the publisher of the DIN standard DIN EN 60601-2-45 .

The standard is based on the international version IEC 60601-2-45. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-45 , see DIN-VDE standards part 7 .

This supplementary standard regulates general specifications for the safety, tests and guidelines of X-ray mammography devices and mammographic stereotaxic devices. The purpose is to describe features of the basic safety as well as tests and to give additional instructions for their application.

validity

The German edition 9.2003 is accepted as a German standard from the date of its publication .

The current version (9.2003) is to be used in accordance with the 2nd edition of DIN EN 60601-1 .
In April 2009 a draft for the corresponding application was published with the 3rd edition of DIN EN 60601-1.

scope of application

These special stipulations contain requirements for the safety of X-ray machines designed for mammography and for mammographic stereotaxic devices. The safety requirements for the X-ray generator and its assemblies form an integral part of this standard.

extra information

The following changed requirements are contained in EN 60601-2-45 (extract):

Protection against electric shock
Protection against mechanical hazards (mechanical strength, moving parts)
Protection from radiation
Protection against dangerous initial values
Constructive requirements