IEC 60601-2-93 ED1

Medical electrical equipment - Part 2-93: Particular requirements for the basic safety and essential performance of neutron capture therapy equipment

Апстракт

IEC 60601-2-93:2026 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of accelerator-based NCT ME EQUIPMENT, hereafter referred to as ME EQUIPMENT, used for TREATMENT of PATIENTS.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
This document, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacture and some installation aspects of NCT ME EQUIPMENT
– intended for RADIOTHERAPY in human medical practice, including those in which the selection and DISPLAY of operating parameters can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS),
– that, in NORMAL USE, deliver NEUTRONS produced by charged particles accelerated by a particle accelerator,
and
– intended to be
• for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular SPECIFIED clinical purposes maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE,
• subject to regular QUALITY ASSURANCE performance and calibration checks by a QUALIFIED PERSON.