Abstract

Neutron capture therapy is a treatment performed with a combination of equipment and drugs. This dokument deals with the safety of the neutron capture therapy device, not with the drug. This document applies to NEUTRON CAPTURE THERAPY (NCT) EQUIPMENT when used, for therapy purposes, in medical practice and describes the basic safety and essential performance. This International Standard applies to the Basic Safety and Essential Performance of Neutron Capture Therapy (NCT) ME Equipment used for treatment of patients. This particular standard covers safety aspects of NCT devices in a known geometrical relationship with electron accelerator devices or light ion beam devices and covers protection against electrical hazards, against mechanical hazards, against unwanted and excessive radiation hazards, against excessive temperatures and other hazards. It ensures accuracy of controls and instruments and protection against hazardous outputs, programmable electrical medical systems (PEMS), electromagnetic compatibility of ME-equipment and ME-systems. At present, neutron capture therapy using boron drugs are used in the mainstream of neutron capture therapy. It is not intended that this standard document should in any way inhibit the future development of new designs of equipment that may have operating modes and parameters different from those described herein, provided that such equipment achieves equivalent or better levels of performance for the treatment of patients.

Begin

2023-09-01

Planned document number

DIN EN IEC 60601-2-93

Project number

02231817

Responsible national committee

DKE/GK 813 - Elektrische und mechanische Sicherheit in der radiologischen Technik