Draft Details

Replacement:

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-ray based IMAGE-GUIDED RADIOTHERAPY equipment for use with EXTERNAL BEAM EQUIPMENT (EBE).

This document covers safety aspects of kilovoltage (kV) and megavoltage (MV) X-ray imaging devices integrated in a specified geometrical relationship with EBE for the purpose of IGRT. It covers aspects of communication and relationships between the EXTERNAL BEAM EQUIPMENT and X-ray imaging devices, attached or not directly attached to, but in the same RADIATION shielded area as, and dedicated for use only with, the EXTERNAL BEAM EQUIPMENT.

This document deals with equipment for OFFLINE X-IGRT, ONLINE X-IGRT and REAL-TIME X-IGRT. It covers procedures to reduce the risk of over-reliance on the X-IGRT EBE SYSTEM. For example, in the case of ONLINE X-IGRT, the MANUFACTURER will provide an interactive interface for user interaction with the correction suggested by the system.

This document does not apply to CT SCANNERS, X-RAY EQUIPMENT for RADIOGRAPHY, and X-RAY EQUIPMENT for RADIOSCOPY, that are not intended for use for IGRT.

Requirements that are being tested according to another standard can be identified by the manufacturer. If these requirements are equivalent, retesting is not required, but instead evidence can refer to the CT SCANNER, X-RAY EQUIPMENT for RADIOGRAPHY, or X-RAY for RADIOSCOPY manufacturer's compliance statements or test reports.

If the X-IGRT EQUIPMENT is combined with an MEE, any requirement that is the same for the X-IGRT EQUIPMENT and the MEE, such as a PATIENT POSITIONER, is not required to be tested twice, but can be accepted as tested by the MEE.

This document applies to X-RAY EQUIPMENT for RADIOGRAPHY, RADIOSCOPY, and COMPUTER TOMOGRAPHY used for IGRT.

If a clause or subclause is specifically intended to be applicable to X-IGRT EBE SYSTEMS, the content of that clause or subclause will say so. Where that is not the case, the clause or subclause applies only to X-IGRT EQUIPMENT.

This document, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the MANUFACTURER and some installation aspects of X-IGRT EBE SYSTEMS intended to be

for NORMAL USE, operated under the authority of the RESPONSIBLE ORGANIZATION by QUALIFIED PERSONS having the required skills for a particular medical application, for particular specified clinical purposes, e.g., STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY,

maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and

subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON.

NOTE In this document, all references to installation refer to the installation in the RESPONSIBLE ORGANIZATION'S premises.