There are several international standards for tomography manufacturers that ensure the safety, quality, and performance of tomography machines.
International Electrotechnical Commission Medical electrical equipment 60601 Part -2-44 sets requirements for the safety and performance of X-ray equipment used in diagnostic and therapeutic applications. This standard includes requirements for X-ray tube output, radiation dose limits, electrical safety, and mechanical safety, among other things.
National Electrical Manufacturers Association: Access Controls for Computed Tomography—Identification, Interlocks, and Logs. This title set standards for clinicians; including permissions to selected uses that are above those needed for daily routine scanning, such as the authorization to save protocols and adds provisions to secure the user interface based on a manual lock. Contains the functionality for use in a facility’s quality assurance program such as capturing operator and patient information as well as information related to saved changes in protocols.
International standards setting in this domain will gather pace as “medical tourism” — a term used to describe the practice of traveling to another country for medical treatment — gathers pace.
