prEN 18167
(Main)Quality along the patient pathway in medical imaging in Radiology services
Quality along the patient pathway in medical imaging in Radiology services
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.
Qualität entlang des Patientenpfads in der medizinischen Bildgebung in der Radiologie
Dieses Dokument legt die Anforderungen für die Umsetzung eines Qualitätssystems entlang des Patientenpfads bei Radiologiedienstleistungen fest. Ziel ist es, eine qualitativ hochwertige Bereitstellung aller Aspekte der Untersuchungssicherheit und Patientenversorgung sicherzustellen.
Dieses Dokument befasst sich mit Verfahren, bei denen Röntgenstrahlen, Ultraschall und Magnetresonanz
tomographie am Menschen eingesetzt werden, einschließlich diagnostischer Verfahren und interventioneller Radiologie sowie Anwendungen aus der Ferne. Es gilt in seinen Grundsätzen auch für alle anderen Techniken und Modalitäten, die bei Radiologiedienstleistungen eingesetzt werden.
Das Dokument umfasst:
- die verschiedenen Schritte der Patientenversorgung (von der Überweisung zur bildgebenden Diagnostik, vor, während und nach der Untersuchung);
- die entsprechenden Anforderungen an das Personal und die medizinisch-technische Ausstattung;
- Qualitäts- und Risikomanagement.
Dieses Dokument ist nicht auf Strahlentherapie und Nuklearmedizin, noch auf Geräte und Strahlungskontrol
len anwendbar, die in anderen Normen geregelt sind. Dieses Dokument schließt Anforderungen im
hang mit Forschungs- und Bildungsfragen aus.
Dieses Dokument enthält eine Beschreibung bewährter Verfahren, die als Referenz für Audits, einschließlich klinischer Audits, dient. Die bereits auf europäischer Ebene festgelegte und unter der Verantwortung jedes Landes umgesetzte Methodik für klinische Audits ist jedoch nicht Bestandteil dieses Dokuments.
Qualité du parcours patient en imagerie médicale dans les services de radiologie
Le présent document spécifie les exigences de mise en oeuvre d’un système de qualité tout au long du parcours patient dans les services de radiologie. L’objectif consiste à garantir la qualité de tous les aspects de la sécurité des examens et des soins prodigués aux patients.
Le présent document porte sur les procédures utilisant les rayons X, l’échographie et l’imagerie par résonance magnétique sur des personnes, couvrant les procédures de radiologie diagnostique et interventionnelle, ainsi que les pratiques à distance. Il s’applique également par principe à toute autre technique et modalité susceptibles d’être utilisées dans les services de radiologie.
Le document traite :
- des différentes étapes de la prise en charge des patients (de la demande d’examen, aux étapes avant, pendant et après l’examen) ;
- des ressources humaines correspondantes et des exigences médico-techniques ;
- du management de la qualité et de la gestion des risques.
Le présent document ne s’applique pas à la radiothérapie, à la médecine nucléaire, ni aux contrôles de l’équipement et des rayonnements utilisés, qui sont couverts par d’autres normes. Le présent document exclut les exigences relatives aux thématiques de la recherche et de la formation.
Il établit une description des bonnes pratiques qui constitue une référence pour les audits, notamment les audits cliniques. Néanmoins, la méthodologie des audits cliniques, d’ores et déjà définie au niveau européen et mise en oeuvre sous la responsabilité de chaque pays, est exclue du présent document.
Kakovost klinične poti pacienta pri medicinskem slikanju v storitvah radiologije
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2025
Kakovost klinične poti pacienta pri medicinskem slikanju v storitvah radiologije
Quality along the patient pathway in medical imaging in Radiology services
Qualität entlang des Patientenpfads in der medizinischen Bildgebung in der Radiologie
Qualité du parcours patient en imagerie médicale dans les services de radiologie
Ta slovenski standard je istoveten z: prEN 18167
ICS:
03.100.70 Sistemi vodenja Management systems
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2025
ICS 03.100.70; 11.040.50
English Version
Quality along the patient pathway in medical imaging in
Radiology services
Démarche qualité du parcours patient en imagerie Qualität entlang des Patientenpfads in der
médicale medizinischen Bildgebung
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 470.
If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations
which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 18167:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Background information . 11
4.1 Which healthcare services are concerned? . 11
4.2 Where are these healthcare services provided? . 11
4.3 Who performs the procedures defined in this document? . 12
4.4 Who can access the healthcare services concerned? . 12
4.5 What are the characteristics of these healthcare services? . 12
4.6 When do the rules outlined in this document apply? . 13
5 Technical medical requirements . 13
5.1 General. 13
5.2 Human resources . 13
5.2.1 General. 13
5.2.2 Qualifications . 13
5.2.3 Entitlements. 14
5.2.4 New arrivals and training . 15
5.3 Premises and facilities requirements . 15
5.4 Imaging medical devices, healthcare products and other equipment . 17
5.4.1 General. 17
5.4.2 Imaging medical devices . 17
5.4.3 Healthcare products (medical devices implantable or not, medicines including
contrast agents) . 17
5.4.4 Other equipment . 18
5.5 Information systems and Data management . 18
5.6 Measures in hygiene and infection prevention . 20
5.6.1 Hygiene control . 20
5.6.2 Management of infected and/or immune-compromised patients . 20
5.6.3 Premises maintenance and cleaning . 20
5.6.4 Other equipment maintenance and cleaning . 20
5.6.5 Linen management . 21
5.6.6 Waste and discharges control . 21
5.7 Protection against ionising radiation . 22
5.7.1 General. 22
5.7.2 Responsibilities . 22
5.7.3 Education, training and entitlement . 22
5.7.4 Dose monitoring . 22
5.7.5 Premises (controlled and supervised areas) . 23
5.7.6 Categorization of professionals . 23
5.7.7 Protection procedures for professionals, patients and the public . 23
5.8 Safety with non-ionising radiation . 23
5.8.1 General. 23
5.8.2 Responsibilities . 24
5.8.3 MRI safety, education, training and entitlement . 24
5.8.4 Premises, equipment and access control . 24
5.8.5 Protection procedures for professionals and patients . 25
5.8.6 Specific actions in the event of an unexpected incident in MRI . 25
5.9 Identity vigilance . 25
5.10 Artificial Intelligence (AI) . 25
6 Patient pathway for a MI procedure . 26
6.1 Imaging referral for MI procedures . 26
6.2 Justification and approval of the imaging referral . 27
6.3 Patient information and making an appointment . 27
6.3.1 Patient information and informed consent . 27
6.3.2 Making an appointment . 28
6.4 Arrival of the patient in the MI organization . 29
6.5 Conducting the MI procedure . 30
6.6 Medical accidents and incidents . 30
6.7 Monitoring patients after an MI procedure . 31
6.8 MI procedure report . 31
6.8.1 General . 31
6.8.2 Content of the report . 32
6.8.3 Validation of the report . 32
6.8.4 Delivery of, and access to the report . 33
6.8.5 Revised reports . 33
6.9 Specific organizational measures . 33
6.9.1 Confidentiality . 33
6.9.2 Participation in out-of-hours service/emergencies . 34
6.9.3 Organization of relations with stakeholders throughout the MI procedure . 34
6.9.4 Interventional imaging . 34
6.9.5 Teleradiology, remote primary reading and remote scanning . 35
6.9.6 Implementation of new practices . 38
7 The quality management and risk management system of the MI organization . 38
7.1 General . 38
7.2 Definition of the quality policy . 40
7.3 Objectives of the quality policy . 40
7.4 Involvement of the senior management of the MI organization . 40
7.5 Ro
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