EN 60601-2-1

Area	Medical technology
title	Medical electrical equipment - Part 2-1: Special requirements for the safety of electron accelerators in the range from 1 MeV to 50 MeV
Latest edition	12.2003
ISO	IEC 60601-2-1: 1998 + A1: 2002

The EN 60601-2-1 entitled "Electrical Medical devices - Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV" is part of the series of standards EN 60601 .

The DIN standard DIN EN 60601-2-1 is published by the German Institute for Standardization .

The standard is based on the international version IEC 60601-2-1. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-1 , see DIN-VDE standards part 7 .

This supplementary standard regulates general requirements for safety, tests and guidelines for electron accelerators in the range from 1 MeV to 50 MeV.

validity

The German edition of 12.2003 has been adopted as a German standard from 6.2005 .

In July 2008 a new draft was published.
The current version (12.2003) is to be used in accordance with the 2nd edition of DIN EN 60601-1.
The draft of 7th 2008 is to be applied corresponding to the 3rd edition of DIN EN 60601-1.

scope of application

The special requirements, including type tests and acceptance tests, relate to the manufacture and some aspects of the installation of electron accelerators,

which are intended for human medical radiation medicine, including those in which the preselection and display of operating parameters can be automatically controlled by programmable electronic subsystems (PESS),
which in the normal state (NC) and when used as intended, also generate a useful beam (X-rays and / or electron beams)
- a nominal energy in the range from 1 MeV to 50 MeV,
- maximum absorbed dose rate between 0.001 Gys-1 and 1 Gys-1 at a distance of 1 m from the radiation source,
- normal irradiation distances (NTD) between 0.5 m and 2 m from the radiation source

and which are provided

for the intended use by users who work under the supervision of an appropriately authorized or qualified person and who have the necessary skills for a specific medical application and defined clinical tasks, e.g. B. for standing field radiation or movement radiation
for maintenance according to the recommendations given in the instructions for use,
for regular quality assurance measures and calibration checks carried out by a qualified person,
for use under environmental conditions and electrical supply conditions as specified in the technical description.

extra information

The following changed requirements are contained in EN 60601-2-1 (extract):

Moving Parts Safety
Mechanical strength (including patient positioning)
Protection against dangerous initial values (radiation)
Radiation intensity