CAN/CSA-C22.2 No. 60601-2-43:03 (R2007)

This National Standard of Canada is equivalent to International Standard IEC 60601-2-43:2000 (first edition, 2000-06). 1 Scope and object This clause of the General Standard applies, except as follows: 1.1 Scope Addition: This Particular Standard applies to X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for prolonged RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES. Its scope excludes, in particular: - equipment for RADIOTHERAPY; - equipment for COMPUTED TOMOGRAPHY; - ACCESSORIES intended to be introduced into the PATIENT; - mammographic X-RAY EQUIPMENT. NOTE - 1 Examples of prolonged RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, for which the use of EQUIPMENT complying with this standard is recommended, are given in annex BB. NOTE 2 - The particular requirements of this standard are not essential for EQUIPMENT used in all RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES. Examples of procedures, for which the use of EQUIPMENT complying with this standard is considered not to be essential, are given in annex BB. EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, which does not include a PATIENT SUPPORT as part of the system, is exempt from the PATIENT SUPPORT provisions of this standard. 1.2 Object Replacement: The object of this standard is: - to establish safety requirements for the design and manufacture of X-RAY EQUIPMENT for prolonged RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES; - to specify information which is to be provided with such EQUIPMENT for the assistance of the USER and OPERATOR in managing the RADIATION risk arising from these procedures which could affect PATIENTS and staff.