Series in Biomedical Engineering. Series editor Joachim H. Nagel, Stuttgart, Germany

Transcription

1 Series in Biomedical Engineering Series editor Joachim H. Nagel, Stuttgart, Germany

2 This series describes the applications of physical science, engineering and mathematics in medicine and biology. The books are written for graduate students and researchers in many disciplines including medical physics, biomedical engineering, radiology, radiotherapy and clinical research. The Series in Biomedical Engineering is the official book series of the International Federation for Medical and Biological Engineering. The IFMBE is an association of constituent societies and organizations which was established in 1959 to encourage and promote international collaboration in research and practice of the profession as well as in the management of technology and the use of science and engineering in medicine and biology for improving health and quality of life. Its activities include participation in the formulation of public policy and the dissemination of information through publications and forums. The IFMBE as the only international organization and WHO/UN accredited NGO covering the full range of biomedical/clinical engineering, healthcare, and healthcare technology management, represents through its 50 national and international member societies more than professionals involved in the issues of improved health care delivery. The IFMBE is associated with the International Union for Physical and Engineering Sciences in Medicine (IUPESM). Through the IUPESM, the IFMBE is a member of the International Council for Science (ICSU). More information about this series at

3 Almir Badnjević Mario Cifrek Ratko Magjarević Zijad Džemić Editors Inspection of Medical Devices For Regulatory Purposes 123

4 Editors Almir Badnjević Medical Devices Verification Laboratory Verlab Ltd Sarajevo Sarajevo Bosnia and Herzegovina Mario Cifrek Faculty of Electrical Engineering and Computing University of Zagreb Zagreb Croatia Ratko Magjarević Faculty of Electrical Engineering and Computing University of Zagreb Zagreb Croatia Zijad Džemić Institute of Metrology of Bosnia and Herzegovina Sarajevo Bosnia and Herzegovina ISSN Series in Biomedical Engineering ISBN ISBN (ebook) Library of Congress Control Number: Springer Nature Singapore Pte Ltd This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Printed on acid-free paper This Springer imprint is published by Springer Nature The registered company is Springer Nature Singapore Pte Ltd. The registered company address is: 152 Beach Road, #21-01/04 Gateway East, Singapore , Singapore

5 Contents Introduction... 1 Almir Badnjević, Mario Cifrek, Ratko Magjarević and Zijad Džemić Regulations and Directives Past, Present, Future... 5 Haris Memić, Almir Badnjević and Zijad Džemić Legal Metrology System Past, Present, Future Alen Bošnjaković, Almir Badnjević and Zijad Džemić Part I Inspection and Testing of Diagnostic Devices Inspection and Testing of Electrocardiographs (ECG) Devices Ratko Magjarević and Almir Badnjević Inspection and Testing of Noninvasive Blood Pressure Measuring Devices Igor Lacković Inspection and Testing of Diagnostic Ultrasound Devices Gordana Žauhar, Ana Diklić and Slaven Jurković Inspection and Testing of Electroencephalographs, Electromyographs, and Evoked Response Equipment Mario Cifrek Part II Inspection and Testing of Therapeutic Devices Inspection and Testing of Defibrillators Milan Ljubotina Inspection and Testing of Respirators and Anaesthesia Machines Baki Karaböce Inspection and Testing of Dialysis Machines Dušanka Bošković v

6 vi Contents Inspection and Testing of Pediatric and Neonate Incubators Lejla Gurbeta, Sebija Izetbegović and Alma Badnjević-Čengić Inspection and Testing of Infusion Pumps Ernesto Iadanza, Diletta Pennati and Fabrizio Dori Cost Effectiveness and Increasing of Accuracy of Medical Devices In Legal Metrology System: Case Study Bosnia and Herzegovina Dijana Vuković, Almir Badnjević and Enisa Omanović-Mikličanin