Due to its considerable importance in the diagnosis of a wide range of diseases and disorders, electrocardiographs (ECG devices) are currently a routine component of diagnostic procedures in healthcare systems. Since the creation of the initial prototype, these devices have undergone evolutionary changes due to advancements in technology, particularly electronics. These devices can now measure several factors simultaneously and do automatic diagnostics. The entire life cycle of a medical device of this type, from creation to disposal, is defined by numerous international standards and regulations. Yet, because of their current level of sophistication, ongoing legal framework changes their accuracy and safety during usage is largely considered. In addition to providing an overview of the criteria in the area of safety and performance inspection of these devices, this chapter discusses the fundamental concepts of electrocardiography and ECG devices. Lastly, a novel method for safety and performance inspection during usage of ECG devices based on their metrological characteristics is introduced.

This chapter provides an overview of the safety aspects of application of ultrasound in medicine. It begins with the short history of ultrasound methods and devices as well as basic principles of ultrasound imaging systems. The application of ultrasound in medicine has highly evolved and nowadays it can be divided into two main areas: imaging and therapy. To assure quality, safe use and responsible application of ultrasound in medicine one should be aware of physical processes which can be produced in tissue by ultrasound such as temperature rise, cavitation, and acoustic streaming. The importance of understanding how these processes can affect the human cell is self-explanatory. To better understand the guidelines for testing and quality control of ultrasonic devices it is necessary to provide an overview of basic output parameters. Only the most important parameters from the point of safe use of ultrasound are described, e.g., acoustic pressure, acoustic power and intensity. To protect the public against inappropriate exposure when ultrasound is used for medical applications, international standards and national regulations are developed. Diagnostic ultrasound imaging is very often the basis for diagnostic decision; therefore, it is also necessary to include such systems into a comprehensive quality assurance programme. Ultrasound systems used for therapy have larger intensities though there are additional safety requirements compared to diagnostic systems. The ultrasound intensity, effective radiation area and beam non-uniformity ratio and are parameters which should be monitored.

The main purpose of the present chapter is to provide an overview of noninvasive blood pressure measuring devices and their inspection and testing. The chapter first introduces systematic classification of methods for blood pressure measurement. Strengths and weaknesses of each method are discussed. Devices for noninvasive blood pressure measurement are described. Several international standards for evaluating the accuracy of blood pressure monitors (AAMI/ANSI SP10, BHS, DIN, IEC, etc.) are compared. This is followed by a section on the inspection and testing of non-invasive blood pressure measuring devices as recommended by the latest guidelines from the International Organization for Legal Metrology (OIML). At the end of this chapter a short summary is given emphasizing the importance of accuracy testing of noninvasive blood pressure measuring devices.

This chapter deals with the inspection of neurodiagnostic equipment for measurement of electrophysiological signals in order to detect eventual problems and prevent them from becoming serious safety risks. The first section of the text gives a brief description of the human neuromuscular system, followed by description and short historical overview of considered neurodiagnostic methods: electroencephalography (EEG) including evoked potentials (EP), electromyography (EMG) and nerve conduction study (NCS). Operating principle of a computer-controlled neurodiagnostic instrument is explained using a generic block diagram. The next sections discuss potential harms and hazards associated with the use of neurodiagnostic equipment as well as standards and regulations concerning basic safety and essential performance requirements. A dedicated section follows up with importance of evidence-based post-market surveillance (PMS), while inspection section describes testing and inspection procedures for periodic testing of modern computer-based neurodiagnostic instruments in the field. Following section is a review of recommendations, contraindications, and warnings for use, while the closing section provides a chapter summary.

This chapter gives an overview of the current cybersecurity issues in medical devices, risks concerning the personal data use, and regulatory recommendations for medical devices with artificial intelligence (AI) technologies. First sections describe general cybersecurity principles, cybersecurity pre- and post-market actions, responsibilities among healthcare stakeholders, and the importance of cybersecurity information disclosure. Data protection subsection provides current regulations on the use of personal health data. Subsection on AI-based medical devices explains the current trends in regulatory approvals for software as medical devices (SaMD) that use artificial intelligence and machine learning (ML) methods. Presented are the regulatory proposals concerning the modifications of medical devices to mitigate operating vulnerabilities and potential patient harm.

Defibrillators are life-saving medical devices that require regular inspection and testing to ensure their functionality and safety. This abstract presents an overview of the inspection and testing process of defibrillators. The inspection includes checking the device’s external and internal components, batteries, and electrodes. Testing involves assessing the device’s energy output, waveform analysis, and battery endurance. Both inspection and testing procedures are necessary to identify any defects or malfunctions that may affect the device’s performance. Regular inspection and testing of defibrillators not only helps to ensure patient safety but also improves the device’s longevity and reliability. Therefore, healthcare professionals responsible for defibrillator management must follow the recommended inspection and testing guidelines to maintain the device’s effectiveness and safety. In this regard, a method based on the metrological properties of defibrillators is presented for safety and performance inspection while in use.

A specific part of human body is focused; a lumbar spine segment with surrounding tissues, biomechanics of which is crucial for maintaining the upward erect body posture and moving the body in the intended direction by means of walking, running and other locomotor modalities. The pelvic segment possesses a pivotal role in the walking process, with biomechanics of the lumbar spine being crucial for realizing dynamic spatialDynamic spatial (3D) movements. Uprising of humans on lower legs during evolution has challenged this body part by subjecting it under big mechanical strain, as best witnessed, unfortunately, by neurosurgical praxis treating spinal injuries resulting from mechanical overloads, a consequence of sports training or occupational tasks. Zagreb school of biomechanics, appearing in second half of twentieth century, is introduced shortly. Approaches of anatomy, orthopedics and mechanical engineering were integrated. Initially viewed as essentialy a static construction, the spine was modeled subsequently as a dynamic mechanical structure. An archival example of in vitro type measurements of mechanical properties of lumbosacral joint speciments is presented in some detail, in the context of evaluating specific surgical interventions. Interlaminectomy has been found a procedure of choice in the treatment of disc hernias of the lumbar spine. Non-invasive in vivo measurements of spine kinematics during normal gait were performed later.

Pedobarography can be used in clinical practice in many areas, as a diagnostic tool, in monitoring of the effect of therapy, both surgical and nonsurgical such as physical therapy and rehabilitation of injuries, painful conditions, degenerative and rheumatic diseases, habilitation of the children with developmental disorders. Pedobarography can also be used as a combination of diagnostics of gait disorders and computer-aided design (CAD) with computer-aided manufacturing (CAM), resulting in producing orthopedic insoles. There is a broad spectrum of possibilities using orthopedic insoles. A number of clinical findings in orthopedics and sports medicine (sports traumatology) are shown and interpreted. The use of orthopedic insoles in the most common diagnoses in orthopedics as there are Flat transverse arch and metatarsalgia, Flat feet and High-arched foot (pes cavus) are presented. The application of orthopedic insoles in different entities in sports medicine like there are Plantar fasciitis, Achilles tendinitis/tendinosis, Flexor hallucis longus muscle dysfunction, Posterior tibial muscle dysfunction, Peroneal muscles dysfunction, Anterior impingement syndrome of the ankle, Sesamoiditis, Stress fractures, Sever disease, Patellar tendinitis/tendinosis (jumper’s knee), Osgood-Schlatter disease and Groin pain are described.

The field of biomedical engineeringBiomedical engineering is introduced and shortly described. Roles played by the fields of biomedical engineeringBiomedical engineering and of biomechanicsBiomechanics in the development of the study of human locomotionHuman locomotion are discussed. Current status of educationEducation of biomedical engineers, worldwide and in Croatia, is commented. Overview of the book follows, pointing shortly to the subject of each chapter. The topics covered are: history of locomotion study and current research methodology; evolution of human gait; elements of biomechanics of the lumbar spine; measuring kinematics and kinetics of human movement; elaboration of 3D photogrammetry; pedobarography; kinesiological electromyography; gait analysis; critical issues in orthopedic traumatology; on sportive movement patterns study. Measurement and analysis of human locomotionHuman locomotion is a multidisciplinary and interdisciplinary topic that requires cooperation among biomedical engineers, medical doctors of several specialties, and kinesiologists.

Human bipedal locomotion is a very complex behavior. The evolution of upright posture and obligate bipedal gait—a central event in the evolution of humankind—took several millions of years and its incentives are still (and surely will be in the future) a subject of scientific debate. Some of the evolutionary milestones are still recognizable in the development of mature gait in toddlers. To provide an overview on evolution and development of human gait, this chapter starts off with a short description of modern human gait modalities—walking, running, and, (arguably) skipping. The broad topic of evolution of human locomotion is first approached by a comparison of the musculoskeletal anatomy of the humans and extant apes. The positive and negative aspects of bipedalism are then tackled, followed by an overview of existing theories on human evolution and theories on evolution of human bipedalism. The chapter finishes off by describing the development of mature gait in toddlers, an amazing chapter in human life in which we could argue that ‘ontogeny recapitulates phylogeny’—the development of the species is reflected in the development of a single person.

Cross section of biomechanical[aut]Biomechanical, predominantly[aut]Biomechanics kinematicsKinematic analysis-oriented, research in the ‘Zagreb kinesiology[aut]kinesiology circle’ is often categorized within division related to: monostructural, polystructural, complex, and aesthetically-conventional kinesiological activities. Movement patterns in sporting activities are represented through reductionist-constructivist dualism. Reductionist[aut]Reductionist sports[aut]Reductionist sports, colloquially called ‘gram-meter-second (GMS) sports’, are essentially reduced to the goal of achieving results through international standards of measurement and measures, e.g. the SI system[aut]Systems. Movement analysis is mostly performed in controlled space (either closed, indoors, such as in a motion analysis laboratory, or outdoors) and with technologies for ‘extended’ sensory-motor circuits, and motion control in general. Examples of javelin throw and sprinting discipline are presented. Constructivist[aut]Constructivist sports, in addition to the physical manifestation of the individual movement, include additional aesthetic component, cooperation, opposition, or some achievement of an externally ruled goal. Movement analysis should imply both GMS dimension of movement and psychosocial and systemic[aut]Systemic elements, such as tasks, tactics, strategy, momentum, etc. Examples of tennis[aut]Constructivist sports serve and team handball jump shot are presented.

Gait analysisGait analysis can be considered a backbone of modern clinical locomotion biomechanics. Basic methodology, integrating kinematic, kinetic and myoelectric measurements in course of a subject's walking and subsequent interpretation of results is summarized and illustrated mainly with findings from our Zagreb and Salerno situated laboratories. In addition, pedobarography and portable oxygen consumption measurement system make desirable components of an equipment inventory for gait analysisGait analysis. Physical examination and observational analysis precede measurement of several gait trials in a laboratory. Interpretation of measurement findings is the next step. Modern tendencies, pursued worldwide, incorporate individualized (subject-specific) neuro-musculo-skeletal modeling into a clinical procedure. Non-linear analysis of gait data emerges as yet another methodology of gait analysis[aut]Gait analysis. Alternative modern tendencies are finally pointed to whereby classical measurement instrumentation setup confined to laboratory environment is substituted by portable, so-called pervasive multisensor measurement solutions offering freedom of movement and aiming to replace classical approach, albeit with no success yet.

A glance on history of the study of human locomotion is given. Major landmarks and most significant contributors are mentioned, that have pursued the development of the approaches intended to get to know the phenomenon of gross human body movement and locomotion. Time period since Antiquity until our days is encompassed. Contribution of each new arising technology (in modern times these were, for instance, high-speed photography, digital computers, new types of sensing, etc.) is outlined. Chapter ends with pinpointing elements of currently attained methodology and paradigms for studying the phenomenon, combining biomechanical approach behind modern measurement, modeling and diagnostics systems, with exercise physiology approach comprising measurement and testing of pulmonary and cardiovascular systems’ performance.

There are many different systems capable of objectively measuring and analyzing various motion parameters and signals. The focus of this chapter is on describing the measurements of kinematic parameters, e.g. spatial position, velocity and acceleration. To this end we introduce a photogrammetric approach where spatial three-dimensional (3D) measurements are derived from 2D camera images. The principle how a camera models 3D world into 2D image is described with the camera model parameters, and the computation of parameters through the camera calibration[aut]Camera calibration procedure is presented. Since 3D kinematic systems[aut]3D kinematic systems operate on a stereo principle, it requires imaging of the scene with minimum of two cameras and their spatial relationship is given in the form of epipolar geometry. We further turn our focus to the usage of 3D kinematic systems3D kinematic systems which is frequently defined by certain measurement protocol, tailored to analyzing a specific movement. Several popular possibilities where 3D kinematic system is jointly used with other types of devices are pointed out. Additionally, an inverse dynamics[aut]Inverse dynamics approach is briefly described and explained, allowing a derivation of internal kinetic data (joint forces and torques) combining an output of a 3D kinematic system with inertial body segment parameters. At the very end, several topics related to the research challenges and the anticipated development of 3D reconstruction systems are presented.

Selected technical solutions aimed at measuring kinematicsKinematics and kineticsKinetics of human locomotion are succinctly pointed to and illustrated. Among kinematic measurement systems the marker-based ones—as the most common—are put forward, making mention of related signal and data processing. Wearable type sensor measurement systems are commented next. Further, kinetic measurement instruments; a force measuring platformForce measuring platform (force plate) and a pedobarograph are addressed shortly. Few examples of measurement results of sportive and normal locomotions are shown and commented to illustrate the methods. These measurement instruments, and related measurement protocols, are to be regarded as an integral part of an inventory at disposal to modern student of human movement.

Neuromuscular level of treatise is pursued, meaning that the motor control aspect comes into focus. In the chain of information transmission—neural impulses serving as information carriers—signal conduction takes place via neural pathways, followed by transmission of excitation to muscle fibers. Skeletal muscle function is presented as seen through its bioelectrical manifestation; electromyographic (or myoelectric) signals (EMG), the signal being modeled in a form of an interference pattern. The method of electromyography is succinctly explained next including technical aspects of signal detection, amplification and registering. In kinesiology, primarily surface electromyography (sEMG) is used. A classical repertoire of signal processing methods in time and in frequency domain is presented next, with interpretations commonly used in biomechanics and kinesiology. It is known as kinesiological electromyography[aut]Electromyography, with principal applications in the evaluation of movement skill and of local muscle fatigue.

Modern orthopedics and traumatology are nowadays impacted ever more by a field of bioengineering. In this chapter the reflections of an orthopedic traumatologist on the area of human locomotion are given. An orthopedic traumatologist has a goal to treat the injuries or diseases of patient’s locomotor system with the highest respect to its biomechanical features and relationships. It is very important for him/her to understand the individual anatomical characteristics and biomechanical performances of each patient’s joints. Therefore, empirically investigated values ​​are described of locomotion capacity and mobilityLocomotion capacity and mobility of individual regions of the locomotor apparatus of the lower extremities of an average patient, known so far. Practical examples of treatment of patients with locomotor system injury are presented through surgical treatment techniques commonly used by the orthopedic traumatologist, including the use of computer-aided surgery (CAS)Computer-aided surgery (CAS) technology when appropriate. In this way, the surgeon tries to bring the end result of treatment as close as possible to the imagined performance of the patient's locomotor system up to the moment of injury. Demonstrated are some practical applications of such treatment options through individual cases of treated patients. The chapter covers critical diagnostics and treatment aspects of hip, kneeKnee and ankleAnkle pathology through presented examples of individual cases.

The measurement method of pedobarography exists in modern form for a few decades already, but relevant actions towards its standardization were undertaken rather recently. The foot can be biomechanically modeled incorporating realistic geometric and material properties of both skeletal and soft tissue components. This may serve to generate simulated contact stress distributions, to be compared with measured pressure data obtained using pedobarography. The method may assume several technical design possibilities employing various types of pressure sensors, the common feature of these systems being that the process of measurement occurs via a contact of a firm (sensor) and a deformable (foot sole) surface. Critical issues regarding standardization of measurement equipment, measurement protocol, and signal processing and interpretation are commented in some detail. An attempted standardization consensus for devices’ performance suited to biomedical instrumentation standards is documented. A short end view on the instrument device in Zagreb laboratory is put forward.

Inspection of Medical Devices—for regulatory purposes is an overview of the expanding and exciting field of Medical Devices in which the reader will find a modern presentation of the relevant aspects of inspection of medical devices as part of the legal metrology system.

This chapter provides an overview of the safety aspects of application of ultrasound in medicine. It starts with the short history of ultrasound methods and devices as well as basic principles of ultrasound imaging systems. The application of ultrasound in medicine greatly evolved and nowadays it can be divided into two main areas: imaging and therapy. In order to assure a safe and responsible application of ultrasound in medicine one should be aware of physical processes which can be produced in tissue by ultrasound such as temperature rise, cavitation and acoustic streaming. The importance of understanding how these processes can affect the human cell is self-explanatory. In order to better understand the guidelines for testing and quality control of ultrasonic devices it is necessary to give an overview of basic output parameters. Only the most important parameters from the point of safe use of ultrasound are described, e.g. acoustic pressure, acoustic power and intensity. In order to protect the public against inappropriate exposure when ultrasound is used for medical applications, international standards and national regulations are developed. Diagnostic ultrasound imaging is very often the basis for diagnostic decision; therefore it is also necessary to include such systems into a comprehensive quality assurance programme. Ultrasound systems used for therapy have larger intensities though there are additional safety requirements compared to diagnostic systems. The ultrasound intensity, effective radiation area and beam non-uniformity ratio and are parameters which should be monitored.

Over the last 50 years of use, defibrillation has been proved to be safe and efficient method to terminate lethal arrhythmias like ventricular fibrillation and ventricular tachycardia without pulse. However, in order to ensure safety and efficacy of this therapy, it is necessary to have a defibrillator which has been tested and proved to be fully functional. Preventive maintenance of all medical devices is highly important to ensure correct diagnosis and therapy, but for defibrillators it is even more important, because a defibrillator is a life-saving device and it is used in the case when a patient life is in danger. Any failure or partial failure of a defibrillator functionality may result in death of a patient. Therefore, there is a zero-tolerance on discrepancies between full functionality of defibrillator, as described in device documentation and actual functionality of defibrillator. Preventive maintenance of defibrillator consists of series of tests which need to be done on the device, with use of special measuring equipment. The most important tests include measurement of output energy which is being delivered from a defibrillator, at all energy levels, to a certain testing impedance. It is also possible to repeat this testing on variable impedance values, and that is highly recommended, because actual patient impedance values will also vary. The documentation for each defibrillator defines tolerance of the delivered energy value, so the actual value must be within prescribed tolerance values, in order to declare the device fully functional. In this chapter, the principles of operation are described too, as well as related standards and the simplest to use kind of defibrillators, called automatic external defibrillators (AEDs).

Electrocardiographs are nowadays standard part of diagnostic procedure in healthcare systems since they have high significance in diagnosis of large number of diseases and disorders. Due to development of technology, especially electronics, these devices have been revolutionized since the first prototype was invented. Nowadays, these devices are able to perform automated diagnosis and measure multiple parameters at once. Multiple international standards define device life circle, from production to disposal. However, this sophistication of ECG devices raises numerous questions regarding safety and accuracy. This chapter describes basic principles of electrocardiography and ECG devices as well as gives overview of requirements in area of safety and performance inspection of these devices.

The main purpose of the present chapter is to provide an overview of noninvasive blood pressure measuring devices and their inspection and testing. The chapter first introduces systematic classification of methods for blood pressure measurement. Moreover strengths and weaknesses of each method are discussed. Devices for noninvasive blood pressure measurement are described. Several international standards for evaluating the accuracy of blood pressure monitors (AAMI/ANSI SP10, BHS, DIN, IEC, etc.) are compared. After that a section on the inspection and testing of noninvasive blood pressure measuring devices as recommended by the International Organization of Legal Metrology (OIML) is presented. At the end of this chapter a short summary is given emphasizing the importance of accuracy testing of noninvasive blood pressure measuring devices.