TESTING OF BIOMEDICAL TECHNOLOGIES

Course objectives

The course aims to train students of the Master of Science in Biomedical Engineering, in agreement with the International and National Core Competence, who have knowledge and skills essential to the performance of the professional activity aimed at the assessment and management of biomedical technologies in healthcare . The course objectives are based on the learning of knowledge, skills and methodologies with particular reference to carry out of the testing on the performance of medical devices. At the end of the learning path the student must be able to acquire professional autonomy, decisional and operational addressed to deal with, identify and manage critical issues during the life cycle of biomedical technologies since they have a high impact on patient and operators safety.

Channel 1
FABIANO BINI Lecturers' profile

Program - Frequency - Exams

Course program
LECTURES Health Spending • Public and private health spending in OECD countries. Public and private health spending in Italy. Spending on biomedical technologies in relation to health spending. Installed base of biomedical equipment in the world and in Italy. Biomedical Technology Market. Regulations in the healthcare sector • MDR Regulation 2017/745, European Directive EEC 42/93 Medical Devices implemented with Legislative Decree 46/97 and EEC Directive 47/2007, implemented with Legislative Decree 37/2010. National regulations and technical legislation. Procedure for obtaining the CE Mark, National classification of medical devices (CND-D.M. 20 February 2007). Health Technology Assessment (HTA) • Health Technology Assessment. Definition, origin and development of Health Technology Assessment (European Directive EEC 24/2001). Health Technology Assessment in Italy (Ministerial Decree 12 March 2015). The Health Technology Assessment process for the acquisition of health technologies. Example of evaluation of the biomedical technology assessment procedure. Clinical Engineering Services: definition, origin and diffusion. The types of Clinical Engineering Services. The role of Clinical Engineering Services in the evaluation and management of biomedical technologies. Procurement Tender Process • European Directive EEC 18/2004. National legislation (Ministerial Decree 163/2006). Procedures for the procurement of medical devices. Example of an information sheet to be attached to the request for quotation. Example of a procedure for the acquisition of biomedical equipment in a healthcare company. Electronic purchasing procedures (Presidential Decree 101/2002). Electronic tenders. Electronic Market of the Public Administration (MEPA). Example of a tender. Example of a technical specification. Example of an electronic purchasing procedure. Testing • Testing of public works: Obligations, aims and purposes. Figure of the tester. Preliminary duties of the tester. Testing operations. Visit report. Tester's reports. The test certificate. General information and procedure for acceptance testing of medical devices. Administrative testing. Acceptance testing of electromedical devices. Procedure and acceptance control sheet for the data archive for the device registry. Procedure and sheet for visual inspection and periodic checks. Notes for electrical safety checks of electromedical devices in premises used for medical purposes according to the technical regulations CEI 62-5 and 62-148. Functional tests. Maintenance • General concepts. Current legislation. Management and maintenance activities of biomedical technologies. Types of maintenance: preventive, fault-related or corrective, periodic and extraordinary. Types of maintenance contracts for technical assistance. Example of maintenance plan procedure. Example of technical inventory procedure. Example of technical sheet of equipment maintenance activities. Quality Control in Ultrasound • Test protocols for verifying the performance of ultrasound scanners. Functional testing of an ultrasound scanner. Guidelines for image evaluation. Ultrasound phantoms. EXERCISES • Guest Lectures held by Professionals representing the Corporate and Public Entity sectors regarding examples of testing and management of the technological park of a healthcare facility. Functional Verification in the Laboratory • Procedure for performing the functional verification relating to the testing of the image of an echotomograph by means of an ultrasound phantom.
Prerequisites
The topics related to the Biomedical Instrumentation II exam are indispensable in order to understand the contents and achieve the learning objectives of the teaching.
Books
TEXTBOOK • F. P. Branca – Fondamenti di Ingegneria Clinica. Volume 2 Ecotomografia – SPRINGER. • Lecture notes by the teacher.
Teaching mode
In the formulation of the training project, the priority is represented by the laboratory test of a functional test that involves the preparation of a final report with an oral exam relating to the interpretation of data and specific technical regulations.
Frequency
Laboratory experience for the execution of the functional test relating to the testing of the image of an ultrasound scanner by means of ultrasound phantom.
Exam mode
In the formulation of the training project, the priority is represented by the presentation in the classroom of ongoing reports by groups regarding the performance of the HTA procedure and the tests conducted in the Bioengineering laboratory during the teaching period. The method of carrying out the summative assessment is oral.
Bibliography
• M. Goodsitt, P. L. Carson, S. Witt, D. L. Hykes, J. M. Koffer Jr, “Real time B-mode ultrasound quality control test procedures-Report of AAPM Ultrasound Task Group n°1”, Med. Phys., 25 (8): 1552-1554, 1998. • J.M. Thijssen, G. Weijers, C.L. De Korte, “Objective performance testing and quality assurance of medical ultrasound equipment”, Ultras. in Med. & Biol., 33(3): 460-471, 2007.
Lesson mode
In the formulation of the training project, the priority is represented by the laboratory test of a functional test that involves the preparation of a final report with an oral exam relating to the interpretation of data and specific technical regulations.
FABIANO BINI Lecturers' profile

Program - Frequency - Exams

Course program
LECTURES Health Spending • Public and private health spending in OECD countries. Public and private health spending in Italy. Spending on biomedical technologies in relation to health spending. Installed base of biomedical equipment in the world and in Italy. Biomedical Technology Market. Regulations in the healthcare sector • MDR Regulation 2017/745, European Directive EEC 42/93 Medical Devices implemented with Legislative Decree 46/97 and EEC Directive 47/2007, implemented with Legislative Decree 37/2010. National regulations and technical legislation. Procedure for obtaining the CE Mark, National classification of medical devices (CND-D.M. 20 February 2007). Health Technology Assessment (HTA) • Health Technology Assessment. Definition, origin and development of Health Technology Assessment (European Directive EEC 24/2001). Health Technology Assessment in Italy (Ministerial Decree 12 March 2015). The Health Technology Assessment process for the acquisition of health technologies. Example of evaluation of the biomedical technology assessment procedure. Clinical Engineering Services: definition, origin and diffusion. The types of Clinical Engineering Services. The role of Clinical Engineering Services in the evaluation and management of biomedical technologies. Procurement Tender Process • European Directive EEC 18/2004. National legislation (Ministerial Decree 163/2006). Procedures for the procurement of medical devices. Example of an information sheet to be attached to the request for quotation. Example of a procedure for the acquisition of biomedical equipment in a healthcare company. Electronic purchasing procedures (Presidential Decree 101/2002). Electronic tenders. Electronic Market of the Public Administration (MEPA). Example of a tender. Example of a technical specification. Example of an electronic purchasing procedure. Testing • Testing of public works: Obligations, aims and purposes. Figure of the tester. Preliminary duties of the tester. Testing operations. Visit report. Tester's reports. The test certificate. General information and procedure for acceptance testing of medical devices. Administrative testing. Acceptance testing of electromedical devices. Procedure and acceptance control sheet for the data archive for the device registry. Procedure and sheet for visual inspection and periodic checks. Notes for electrical safety checks of electromedical devices in premises used for medical purposes according to the technical regulations CEI 62-5 and 62-148. Functional tests. Maintenance • General concepts. Current legislation. Management and maintenance activities of biomedical technologies. Types of maintenance: preventive, fault-related or corrective, periodic and extraordinary. Types of maintenance contracts for technical assistance. Example of maintenance plan procedure. Example of technical inventory procedure. Example of technical sheet of equipment maintenance activities. Quality Control in Ultrasound • Test protocols for verifying the performance of ultrasound scanners. Functional testing of an ultrasound scanner. Guidelines for image evaluation. Ultrasound phantoms. EXERCISES • Guest Lectures held by Professionals representing the Corporate and Public Entity sectors regarding examples of testing and management of the technological park of a healthcare facility. Functional Verification in the Laboratory • Procedure for performing the functional verification relating to the testing of the image of an echotomograph by means of an ultrasound phantom.
Prerequisites
The topics related to the Biomedical Instrumentation II exam are indispensable in order to understand the contents and achieve the learning objectives of the teaching.
Books
TEXTBOOK • F. P. Branca – Fondamenti di Ingegneria Clinica. Volume 2 Ecotomografia – SPRINGER. • Lecture notes by the teacher.
Teaching mode
In the formulation of the training project, the priority is represented by the laboratory test of a functional test that involves the preparation of a final report with an oral exam relating to the interpretation of data and specific technical regulations.
Frequency
Laboratory experience for the execution of the functional test relating to the testing of the image of an ultrasound scanner by means of ultrasound phantom.
Exam mode
In the formulation of the training project, the priority is represented by the presentation in the classroom of ongoing reports by groups regarding the performance of the HTA procedure and the tests conducted in the Bioengineering laboratory during the teaching period. The method of carrying out the summative assessment is oral.
Bibliography
• M. Goodsitt, P. L. Carson, S. Witt, D. L. Hykes, J. M. Koffer Jr, “Real time B-mode ultrasound quality control test procedures-Report of AAPM Ultrasound Task Group n°1”, Med. Phys., 25 (8): 1552-1554, 1998. • J.M. Thijssen, G. Weijers, C.L. De Korte, “Objective performance testing and quality assurance of medical ultrasound equipment”, Ultras. in Med. & Biol., 33(3): 460-471, 2007.
Lesson mode
In the formulation of the training project, the priority is represented by the laboratory test of a functional test that involves the preparation of a final report with an oral exam relating to the interpretation of data and specific technical regulations.
  • Lesson code1047747
  • Academic year2025/2026
  • Coursecorso|33485
  • CurriculumTecnologie ospedaliere
  • Year2nd year
  • Semester2nd semester
  • SSDING-IND/34
  • CFU6
  • Subject areaIngegneria biomedica