EN 60601-2-11

Area	Medical technology
title	Medical electrical equipment - Part 2-11: Particular requirements for the radiation safety of gamma radiation equipment
Latest edition	4.2005
ISO	IEC 60601-2-11: 1997 + A1: 2004

The EN 60601-2-11 with the title "Medical electrical equipment - Part 2-11: Special provisions for the radiation safety of gamma irradiation facilities" is part of the EN 60601 series of standards .

The German Institute for Standardization is the publisher of the DIN standard DIN EN 60601-2-11 .

The standard is based on the international version IEC 60601-2-11. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-11 , see DIN-VDE standards part 7 .

This supplementary standard regulates general requirements for the safety, tests and guidelines of gamma radiation facilities.

validity

The German edition 4.2005 has been accepted as a German standard from 9.2007 .

The current version (4.2005) is to be used in accordance with the 2nd edition of DIN EN 60601-1.
A correction was published on 7/2005.
A draft for the 3rd edition of DIN EN 60601-1 was published on 6/2009.

scope of application

The special stipulations specify requirements for the safety of gamma radiation equipment in human medical radiation therapy . This also includes devices in which the selection and display of operating parameters can be controlled by a programmable electronic system (PES). The standard specifies the requirements for devices and not for radiation sources.

They apply to devices that use enclosed radiation sources and generate a gamma ray bundle at normal radiation distances greater than 5 cm. Special precautionary measures may be necessary for devices that work with smaller distances.

This standard also applies to MSSR that irradiate a single isocenter with more than one enclosed radioactive source at the same time. The sources may be stationary or movable.

The special stipulations apply to devices that

operated by the user under the responsibility of officially authorized or appropriately qualified persons who have the necessary qualifications for a specific medical application and who work in accordance with the instructions for use,
are serviced at fixed time intervals,
are subjected to regular checks by the operator,
used for certain clinical purposes, e.g. B. standing field irradiation or movement irradiation

They also apply to the manufacture and to some aspects of the installation of gamma radiation equipment, including type tests and acceptance tests.

extra information

The following changed requirements are contained in EN 60601-2-11 (extract):

Protection from excessive radiation
Accuracy of the operating data
Protection against dangerous initial values