Naslov
LEGAL METROLOGY FOR MEDICAL DEVICES
(LEGAL METROLOGY: MEDICAL DEVICES)

Autori
Bošnjaković, Alen ; Džemić, Zijad

Vrsta, podvrsta i kategorija rada
Poglavlja u knjigama, stručni

Knjiga
Proceedings of the International Conference on Medical and Biological Engineering 2017

Urednik/ci
Badnjevic, Almir

Izdavač
Springer

Grad
Singapur

Godina
2017

Raspon stranica
583-588

ISBN
978-981-10-4165-5

ISSN
1680-0737

Ključne riječi
Conformity assessment, Legal metrology, Medical devices, Type approval , Verification
(Conformity assessment, Legal metrology, Medical devices , Type approval, Verification)

Sažetak
Medical devices with measuring function are regularly used in healthcare systems all over the world with the aim of prevention, diagnosis, and treatment of diseases. Considering the importance of these devices in daily activities of medical professionals and impact of their measurements on the health of patients, safety and accuracy of their measurements is becoming the topic of interest. Numerous international guidelines define how healthcare institutions should perform these conformity assessment but in some countries, where those guidelines are not adopted, it is necessary to implement directives of new approach for various groups of medical devices. Directives of new approach in terms of medical devices and their conformity assessment can be implemented in the area of legal metrology, as it is done in Bosnia and Herzegovina. This paper presents achievements and activities of Institute of Metrology of Bosnia and Herzegovina (IMBIH), the competent state authority for metrology in Bosnia and Herzegovina, in the area of legal metrology for the particular group of medical devices with measuring function. These achievements and activities refer to the adoption of appropriate legislation for type approval, verification, and creating an adequate legal framework for controlling medical devices after they are sold on the market. In addition, considering complexity and variety of medical devices related to measuring characteristics, and also due to the problem of inadequate or not defined traceability routes, the medical devices will continue to be in focus of metrological practice and science. Establishing the comparative approach to the type approval for these devices in the area of the legal metrology is the final aim.

Izvorni jezik
Engleski

Znanstvena područja
Strojarstvo

POVEZANOST RADA