EN 60601-2-17

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Logo of the German Institute for Standardization DIN EN 60601-2-17
Area Medical technology
title Medical electrical equipment - Part 2-17: Particular requirements for the safety of remotely controlled, automatically operated afterloading devices for brachytherapy
Latest edition 12.2004
ISO IEC 60601-2-17: 2004

The EN 60601-2-17 titled "Electrical Medical devices - Part 2-17: Particular requirements for remote-controlled security, automatic afterloading devices for brachytherapy" is part of the series of standards EN 60601 .

The German Institute for Standardization is the publisher of the DIN standard DIN EN 60601-2-17 .

The standard is based on the international version IEC 60601-2-17. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-17 , see DIN-VDE standards part 7 .

This supplementary standard regulates general specifications for the safety, tests and guidelines of remote-controlled, automatically operated afterloading devices for brachytherapy .

validity

The German edition 12.2004 has been accepted as a German standard from the date of its publication .

  • The current version (12.2004) is to be used in accordance with the 2nd edition of DIN EN 60601-1 .
  • A draft for use with the 3rd edition of DIN EN 60601-1 was published in October 2009.
  • The previous standard DIN EN 60601-2-17: 2003-12 was allowed to be used until 3.2007.

scope of application

These special stipulations define the requirements for the safety of automatically controlled devices for brachytherapy of patients using afterloading technology. It defines requirements for automatically controlled afterloading devices,

  • which contain and use exclusively enclosed radioactive radiation sources with beta, gamma and neutron radiation;
  • which automatically convey the enclosed radioactive radiation source (s) from a storage container to the irradiation position within the applicator (s) and vice versa;
  • designed to be connected to a patient and
  • in which the movements of the radioactive radiation source (s) according to a prescribed program are automatically carried out by the device using a drive mechanism whose changes are controlled by the timer (s) and the timer (s), which are either programmable electronic subsystems (computers or microprocessors) or non-programmable systems.

This standard specifies requirements for devices that are intended to

  • used under the supervision of qualified personnel,
  • waited at fixed intervals,
  • to be checked regularly by the operator.

It does not specify any requirements for the enclosed radioactive radiation sources used in the devices.

The requirements of this standard are based on the assumption that:

  • an irradiation plan is available in which the corresponding values ​​of the irradiation parameters are prescribed, and
  • the source strength (s) of the radioactive radiation sources in the device is / are known.

It contains requirements which are intended to ensure that the prescribed values ​​of the irradiation parameters can be provided by the device, in particular that:

  • the selected radioactive radiation source (s) is / are positioned or moved within the applicator in accordance with the intended arrangement with respect to the applicator;
  • the irradiation is carried out by the selected arrangement of the radioactive radiation sources during the preselected period of time and
  • the irradiation is carried out by the device without creating unnecessary risks for the user and other people in the immediate vicinity.

extra information

The following changed requirements are contained in EN 60601-2-17 (extract):