Medical Electrical Equipment - Part 2-43: Particular Requirements for the Safety of X-Ray Equipment for Interventional Procedures
|Publication Date:||1 June 2000|
|ICS Code (Radiographic equipment):||11.040.50|
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.