Medical electrical equipment — Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

Designation Number:
CSA C22.2 NO. 60601-2-54
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
Amendment Revision
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

The purpose of this new amendment to IEC 60601-2-54 edition 1.0 is to introduce changes which take the current state of the art into account. Therefore, X-ray equipment specified for Direct Radioscopy is no longer in the scope of this document. The normative references were also updated in this amendment, and editorial clarifications and new terms and definitions were added.

 

Provisions for QUALITY CONTROL PROCEDURES to be recommended by the MANUFACTURER are emphasized. Specific attention is paid to EXAMINATION PROTOCOLS in a new subclause which differentiate between adult and pediatric applications, in particular for X-RAY EQUIPMENT without an AUTOMATIC CONTROL SYSTEM. In addition, fixed periods for termination of LOADING after release of the RADIATION control by the OPERATOR are stipulated for RADIOSCOPY.

 

A new subclause on electronic documentation of EXAMINATION PROTOCOLS is introduced. It recommends providing access to electronic documentation containing relevant parameters of the PRE-PROGRAMMED EXAMINATION PROTOCOL. In another new subclause, the creation of basic documentation of the RADIATION DOSE STRUCTURED REPORT (RDSR) according to IEC 61910-1 is recommended. Furthermore, the subclause describing the LAST IMAGE HOLD RADIOGRAM has been revised and requires that the last image in RADIOSCOPY be displayed rather than provide just a means to display it.

 

This amendment recommends providing a graphical DISPLAY of the position of the BEAM LIMITING DEVICE blades on the IMAGE DISPLAY DEVICE in the subclause "Indication on the X-RAY EQUIPMENT". Finally, the requirement for providing means to limit the FOCAL SPOT TO SKIN DISTANCES for radioscopic X-RAY EQUIPMENT differentiates between MOBILE and FIXED EQUIPMENT and extends, in the latter case, the minimum distance in possible clinical applications.

Project need:

To maintain alignment of Canadian requirements with those of international standards in the medical electrical equipment subject area, and update the current standard due to user experience/feedback/new technology.

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