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Standards Development
This document specifies the functional performance characteristics of neutron capture therapy equipment (NCT MEE) when used in medical practice, such as for compensation or mitigation of illness, injury, or disability. The document describes measurement an d test procedures to be performed by manufacturers during the design and construction phase of neutron capture therapy equipment but does not specify acceptance tests to be performed after installation at the purchaser's site.
Radiotherapy is an important method of cancer treatment, and neutron capture therapy systems have been developed in several countries and are currently treating patients. Manufacturers in various countries have obtained government approval to establish a market and are conducting clinical trials for hundreds of patients annually, for example, for patients who have become resistant to conventional radiotherapy or chemotherapy. Recent advances in accelerator technology have led to the development of various t ypes of accelerator- based neutron capture therapy equipment (NCT MEE). The functional performance characteristics of NCT medical electrical equipment (MEE) have a significant impact on radiation safety and treatment effectiveness for patients, and these devices can deliver radiation doses that can be harmful or even fatal to humans if delivered incorrectly. The performance specifications for these accelerators are not standardized and users must evaluate the designs produced by each manufacturer based on limited guidance.
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