Medical electrical equipment — Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam

Designation Number:
CAN/CSA-C22.2 No. 60601-2-68
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
Reaffirmation
ICS code(s):
11.040.60
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

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

This particular standard covers safety aspects of kilovoltage (kV) and megavoltage (MV) X-ray imaging devices in a known 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 particular standard deals with equipment for REAL-TIME X-IGRT, ONLINE X-IGRT and OFFLINE X-IGRT. It covers procedures to reduce the risk of over-reliance on the X-IGRT EXTERNAL BEAM SYSTEM (X-IGRT EBS). For example the manufacturer will provide an interactive interface for user interaction with the correction suggested by the system.

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. If that is not the case, the clause or subclause applies only to X-IGRT EQUIPMENT.

This particular standard, 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 appropriately licensed or QUALIFIED PERSONS by OPERATORS 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
  •  subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON.


NOTE In this particular standard, all references to installation refer to installation in the RESPONSIBLE ORGANIZATION’S premises

Project need:

To review the Standard within the required 5 year period.

Note: The information provided above was obtained by the Standards Council of Canada (SCC) and is provided as part of a centralized, transparent notification system for new standards development. The system allows SCC-accredited Standards Development Organizations (SDOs), and members of the public, to be informed of new work in Canadian standards development, and allows SCC-accredited SDOs to identify and resolve potential duplication of standards and effort.

Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.