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Legal Metrology System—Past, Present, Future

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Inspection of Medical Devices

Part of the book series: Series in Biomedical Engineering ((BIOMENG))

Abstract

Through the chapter Legal Metrology System—Past, Present, Future a significant role of legal metrology is presented in the area of development of human civilization, which has led to the consistency of measurements in everyday life. The current state of legal metrology on the International and on the European level is described. Furthermore, through the chapter the legislation of the European Union is presented, which includes directives of the New Approach, with special reference to the Medical Devices Directive, which deals with medical devices with a measuring function. Through the chapter the necessity, as well as the challenges for placing these devices into the framework of legal metrology is presented. In addition, the role of legal metrology and the factors that will have an impact on its development in the future is described.

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References

  1. BIPM. http://www.bipm.org/en/worldwide-metrology/, last access date 24.8.2016

  2. BIPM. http://www.bipm.org/en/worldwide-metrology/metre-convention/, last access date 24.8.2016

  3. OIML B1 (E:1968)—OIML Convention

    Google Scholar 

  4. Chappell S (2004) Opportunities and future trends in legal metrology control of measuring instruments. Organisation Internationale de Métrologie Légale (OIML). Bulletin 55(1):25–28

    Google Scholar 

  5. International vocabulary of terms in legal metrology (VIML) E:2013

    Google Scholar 

  6. OIML on-line vocabulary, http://viml.oiml.info/en/index.html, last access date 24.8.2016

  7. Birch J (2004) The expanding scope of legal metrology and the changing role of the state in a globalization world. Organisation Internationale de Métrologie Légale (OIML). Bulletin 55(1):23–24

    Google Scholar 

  8. Mason P (2016) Re-thinking Legal Metrology Organisation Internationale de Métrologie Légale (OIML). Bulletin 1:14–17

    Google Scholar 

  9. Organisation Internationale de Métrologie Légale/ International Organization of Legal Metrology

    Google Scholar 

  10. OIML B15 (E:2011)—OIML Strategy

    Google Scholar 

  11. OIML, https://www.oiml.org/en/about/legal-metrology, last access date 20.8.2016

  12. OIML, https://www.oiml.org/en/about/benefits?set_language=en, last access date 20.8.2016

  13. Awosola M (2010) Working across cultures in OIML TCs and SCs. Organisation Internationale de Métrologie Légale (OIML). Bulletin 51(3):17–19

    Google Scholar 

  14. OIML. https://www.oiml.org/en/structure/members, last access date 20.8.2016

  15. OIML. https://www.oiml.org/en/structure/ciml, last access date 20.8.2016

  16. OIML. https://www.oiml.org/en/structure/conference?set_language=en, last access date 20.8.2016

  17. Le Comité international de métrologie légale (CIML)/The International Committee of Legal Metrology

    Google Scholar 

  18. Le Bureau international de métrologie légale (BIML)/The International Bureau of Legal Metrology

    Google Scholar 

  19. OIML. https://www.oiml.org/en/technical-work/tc-sc/tclist_view, last access date 20.8.2016

  20. OIML. https://www.oiml.org/en/structure/biml, last access date 20.8.2016

  21. WTO Technical Barriers to Trade (TBT) Committee

    Google Scholar 

  22. Kochsiek M, Andreas O (2001) Towards a global measurement system: contributions of international organizations. Organisation Internationale de Métrologie Légale (OIML). Bulletin 42(2):14–19

    Google Scholar 

  23. Basic Certificate System for Measuring Instruments

    Google Scholar 

  24. OIML B3 (E:2011)—OIML Basic Certificate System for OIML Type Evaluation of Measuring Instruments

    Google Scholar 

  25. OIML Systems Basic and MAA Certificates (2016) OIML Bulletin 67(2):39

    Google Scholar 

  26. OIML B10 (E:2011)—Framework for a Mutual Acceptance Arrangement on OIML Type Evaluations (Integrating the changes in the 2012 Amendment)

    Google Scholar 

  27. ISO/IEC 17065—Conformity assessment—Requirements for bodies certifying products, processes and services

    Google Scholar 

  28. ISO/IEC 17025—General requirements for the competence of testing and calibration laboratories

    Google Scholar 

  29. OIML. https://www.oiml.org/en/certificates/maa-certificates, last access date 20.8.2016

  30. WELMEC. http://www.welmec.org/welmec/welmec-tour/welmec-information/, last access date 21.08.2016

  31. The European Free Trade Association (EFTA) is an intergovernmental organization set up for the promotion of free trade and economic integration to the benefit of its four Member States: Iceland, Liechtenstein, Norway, Switzerland

    Google Scholar 

  32. WELMEC. http://www.welmec.org/welmec/welmec-tour/welmec-organization/, last access date 22.8.2016

  33. Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonization of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments (recast). Applicable on 20 April 2016 OJ L 96, 29 March 2014

    Google Scholar 

  34. Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonization of the laws of the Member States relating to the making available on the market of measuring instruments (recast). Applicable from 20 April 2016 OJ L 96, 29 March 2014

    Google Scholar 

  35. NIST. http://www.nist.gov/pml/wmd/ilmg/org-primer.cfm, last access date 21.08.2016

  36. SIM. http://www.sim-metrologia.org.br/, last access date 21.08.2016

  37. APLMF. http://www.aplmf.org/, last access date 21.08.2016

  38. COOMET. http://www.coomet.net/, last access date 21.08.2016

  39. Directive 93/68/EEC. http://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX:31993L0068, last access date 23.8.2016

  40. WELMEC. http://www.welmec.org/welmec/country-info/bosnia-and-herzegovina/, last access date 23.8.2016

  41. Oosterman C, Dixon P (2012) NoBoMet: a European platform for notified bodies working in legal metrology. Organisation Internationale de Métrologie Légale (OIML). Bulletin 53(1):11–13

    Google Scholar 

  42. Directive 765/2008 EC amends Directive 768/2008/EC

    Google Scholar 

  43. Nando (New Approach Notified and Designated Organizations) Information System,

    Google Scholar 

  44. http://ec.europa.eu/growth/tools-databases/nando/, last access date 23.8.2016

  45. OIML V1, International vocabulary of terms in legal metrology (VIML) E:2013 Directive 768/2008/EC. http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1471938874347&uri=CELEX:32008D0768, last access date 23.8.2016

  46. Netherlands Measurement Institute (NMI)

    Google Scholar 

  47. Czech Metrology Institute (CMI)

    Google Scholar 

  48. Laboratoire national de métrologie et d’essais (LNE)

    Google Scholar 

  49. National Measurement and Regulation Office (NMO)

    Google Scholar 

  50. Swiss Federal Institute of Metrology (METAS)

    Google Scholar 

  51. NoBoMet. https://sites.google.com/site/portalnobomet/home, last access date 23.8.2016

  52. European Commission. https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/implantable-medical-devices_en, last access date 24.8.2016

  53. European Commission. https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en, last access date 24.8.2016

  54. European Commission. https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices_en, last access date 24.8.2016

  55. European Commission. http://ec.europa.eu/consumers/sectors/medical-devices/files/revision_docs/2007–47-en_en.pdf, last access date 24.8.2016

  56. WELMEC. http://www.welmec.org/welmec/country-info/bosnia-and-herzegovina/, last access date 24.8.2016

  57. International Vocabulary of Metrology—Basic and General Concepts and Associated Terms (VIM 3rd edition), JCGM 200:2012

    Google Scholar 

  58. do Céu Ferreira M (2011) The role of metrology in the field of medical devices. Organisation Internationale de Métrologie Légale (OIML). Bulletin 2(2):135–140

    Google Scholar 

  59. European Association of National Metrology Institutes (EURAMET)

    Google Scholar 

  60. EURAMET. http://msu.euramet.org/current_calls/research_2016/SRTs/SRT-r03.pdf, last access date 24.8.2016

  61. OIML. https://www.oiml.org/en/publications/recommendations/publication_view?p_type=1&p_status=1, last access date 24.8.2016

  62. Tanaka M (2004) Measuring instrument technology and customers and contractors of legal metrology in the mid 21st century. Organisation Internationale de Métrologie Légale (OIML). Bulletin 55(1):29–31

    Google Scholar 

  63. Badnjevic A, Gurbeta L, Boskovic D, Dzemic Z (2015) Measurement in medicine—past, present, future. Folia Medica Facultatis Medicinae Universitatis Saraeviensis Journal 50(1):43–46

    Google Scholar 

  64. Badnjevic A, Gurbeta L, Boskovic D, Dzemic Z (2015) Medical devices in legal metrology, IEEE 4th Mediterranean Conference on Embedded Computing (MECO), pp 365–367, 14–18 June, Budva, Montenegro

    Google Scholar 

  65. Gurbeta L, Badnjevic A, Pinjo N, Ljumic F (2015) Software package for tracking status of inspection dates and reports of medical devices in Healthcare Institutions of Bosnia and Herzegovina, XXV International Conference on Information, Communication and Automation Technologies (IEEE ICAT), pp 1–5, 29–31 October 2015, Sarajevo, Bosnia and Herzegovina

    Google Scholar 

  66. Gurbeta L, Badnjevic A, Sejdinovic D, Alic B, Abd El-Ilah L, Zunic E (2016) Software solution for tracking inspection processes of medical devices from legal metrology system, XIV Mediterranean Conference on Medical and Biological Engineering and Computing (MEDICON), 31. March—02. April 2016. Paphos, Cyprus

    Google Scholar 

  67. Gurbeta L, Badnjevic A (2016) Inspection process of medical devices in healthcare institutions: software solution. Health Technol. doi:10.1007/s12553-016-0154-2

    Google Scholar 

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Author information

Authors and Affiliations

  1. Institute of Metrology of Bosnia and Herzegovina (IMBIH), Sarajevo, Bosnia and Herzegovina

    Alen Bošnjaković & Zijad Džemić

  2. Medical Devices Verification Laboratory, Verlab Ltd Sarajevo, Sarajevo, Bosnia and Herzegovina

    Almir Badnjević

Authors
  1. Alen Bošnjaković
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  2. Almir Badnjević
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  3. Zijad Džemić
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Corresponding author

Correspondence to Alen Bošnjaković .

Editor information

Editors and Affiliations

  1. Verlab Ltd Sarajevo, Medical Devices Verification Laboratory, Sarajevo, Bosnia and Herzegovina

    Almir Badnjević

  2. Faculty of Electrical Engineering and Computing Zagreb, University of Zagreb, Zagreb, Croatia

    Mario Cifrek

  3. Faculty of Electrical Engineering and Computing Zagreb, University of Zagreb, Zagreb, Croatia

    Ratko Magjarević

  4. Institute of Metrology of Bosnia and Herzegovina, Sarajevo, Bosnia and Herzegovina

    Zijad Džemić

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Bošnjaković, A., Badnjević, A., Džemić, Z. (2018). Legal Metrology System—Past, Present, Future. In: Badnjević, A., Cifrek, M., Magjarević, R., Džemić, Z. (eds) Inspection of Medical Devices . Series in Biomedical Engineering. Springer, Singapore. https://doi.org/10.1007/978-981-10-6650-4_3

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  • DOI: https://doi.org/10.1007/978-981-10-6650-4_3

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  • Publisher Name: Springer, Singapore

  • Print ISBN: 978-981-10-6649-8

  • Online ISBN: 978-981-10-6650-4

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