scope:

This document describes and defines the process of refurbishment of used medical imaging equipment and applies to the restoring of used medical imaging equipment to a condition of safety and effectiveness comparable to that of new equipment. This restoration includes actions such as repair, rework, software/hardware updates, and the replacement of worn parts with original parts. This document enumerates the actions, that must be performed, and the manner consistent, with relevant specifications and service procedures required to ensure that the refurbishment of medical imaging equipment is done without changing the finished medical imaging equipment's performance, safety specifications, or intended use according to its original or applicable valid registration. The medical imaging equipment and systems covered by this standard include: - X-RAY EQUIPMENT; - X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES ; - X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY; - MAGNETIC RESONANCE EQUIPMENT; - ULTRASONIC DIAGNOSTIC EQUIPMENT; - GAMMA CAMERAS; - PLANAR W HOLEBODY IMAGING EQUIP MENT; - Equipment for SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT); - SPECT/CT hybrid systems, combining a GAMMA CAMERA with X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (CT); - POSITRON EMISSION TOMOGRAPHS (PET); - PET/CT hybrid systems combining a POSITRON EMISSION TOMOGRAPH with X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (CT); - PET/MRI hybrid systems combining a POSITRON EMISSION TOMOGRAPH with MAGNETIC RESONANCE EQUIPMENT: and - other combinations of the equipment or systems listed above. This standard does not apply to endoscopic equipment, funduscopic equipment, radiation therapy equipment, nor associated systems.