CEN/TC 470 - Quality in medical imaging along the patient pathway
Standardization in the field of medical imaging and radio diagnostics. It includes medical imaging for diagnostic and interventional purposes. The objective is to ensure quality and safety in patient care. It covers procedures using ionizing and electromagnetic radiation or ultrasonography, performed on the human being, in person or remotely (telemedicine). This standardization is intended for all medical imaging structures. Excluded are: - radiotherapy, - conventional optical imaging (such as endoscopy or fundus), - photography of patients or lesions, - anatomical pathology. Standardization related to equipment and radiation protection is also excluded as it already covered by IEC (IEC TC/SC 62B 'Diagnostic imaging equipment' and IEC TC/SC 62C 'Equipment for radiotherapy, nuclear medicine and radiation dosimetry') and ISO/TC 85 and CEN/TC 430 'Nuclear energy, nuclear technologies, and radiological protection'.
Quality in medical imaging along the patient pathway
Standardization in the field of medical imaging and radio diagnostics. It includes medical imaging for diagnostic and interventional purposes. The objective is to ensure quality and safety in patient care. It covers procedures using ionizing and electromagnetic radiation or ultrasonography, performed on the human being, in person or remotely (telemedicine). This standardization is intended for all medical imaging structures. Excluded are: - radiotherapy, - conventional optical imaging (such as endoscopy or fundus), - photography of patients or lesions, - anatomical pathology. Standardization related to equipment and radiation protection is also excluded as it already covered by IEC (IEC TC/SC 62B 'Diagnostic imaging equipment' and IEC TC/SC 62C 'Equipment for radiotherapy, nuclear medicine and radiation dosimetry') and ISO/TC 85 and CEN/TC 430 'Nuclear energy, nuclear technologies, and radiological protection'.
General Information
This document specifies the requirements for implementation of a quality system along the patient pathway in Radiology services. The objective is to ensure high quality delivery of all aspects of the examination safety and patient care.
This document deals with procedures using X-rays, ultrasonography and magnetic resonance imaging on humans, including diagnostic procedures and interventional Radiology as well as remote practices. It also applies, in its principles, to any other technique and modality that would be used in Radiology services.
The document covers:
- the different steps of patient care (from the imaging referral, before, during, and after the examination);
- the corresponding human resources and technical-medical requirements;
- quality and risk management.
This document does not apply to radiotherapy and nuclear medicine, nor to equipment and radiation controls which are covered in other standards. This document excludes requirements related to research and education themes.
This document establishes best practices description which constitutes a reference for audits, including clinical audits. Nevertheless, the clinical audits methodology, already defined at the European level, and implemented under the responsibility of each country is excluded from the document.
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