000 03776nam a22006375i 4500
001 978-981-10-6650-4
003 DE-He213
005 20220801215721.0
007 cr nn 008mamaa
008 171026s2018 si | s |||| 0|eng d
020 _a9789811066504
_9978-981-10-6650-4
024 7 _a10.1007/978-981-10-6650-4
_2doi
050 4 _aR856-857
072 7 _aMQW
_2bicssc
072 7 _aTEC059000
_2bisacsh
072 7 _aMQW
_2thema
082 0 4 _a610.28
_223
245 1 0 _aInspection of Medical Devices
_h[electronic resource] :
_bFor Regulatory Purposes /
_cedited by Almir Badnjević, Mario Cifrek, Ratko Magjarević, Zijad Džemić.
250 _a1st ed. 2018.
264 1 _aSingapore :
_bSpringer Nature Singapore :
_bImprint: Springer,
_c2018.
300 _aVI, 289 p. 84 illus., 50 illus. in color.
_bonline resource.
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _atext file
_bPDF
_2rda
490 1 _aSeries in Biomedical Engineering,
_x1864-5771
505 0 _aIntroduction -- Regulations and Directives – past, present, future -- Legal Metrology System – past, present, future -- Inspection of Diagnostic Medical Devices -- Inspection of Therapeutic Medical Devices -- Telemedicine Procedures -- Conclusion.
520 _aThis book offers all countries a guide to implementing verification systems for medical devices to ensure they satisfy their regulations. It describes the processes, procedures and need for integrating medical devices into the legal metrology framework, addresses their independent safety and performance verification, and highlights the associated savings for national healthcare systems, all with the ultimate goal of increasing the efficacy and reliability of patient diagnoses and treatment. The book primarily focuses on diagnostic and therapeutic medical devices, and reflects the latest international directives and regulations. Above all, the book demonstrates that integrating medical devices into the legal metrology system and establishing a fully operational national laboratory for the inspection of medical devices could significantly improve the reliability of medical devices in diagnosis and patient care, while also reducing costs for the healthcare system in the respective country.
650 0 _aBiomedical engineering.
_93292
650 0 _aMeasurement.
_928731
650 0 _aMeasuring instruments.
_910420
650 0 _aSecurity systems.
_931879
650 0 _aBiotechnology.
_97533
650 0 _aMedical laws and legislation.
_946048
650 1 4 _aBiomedical Engineering and Bioengineering.
_931842
650 2 4 _aMeasurement Science and Instrumentation.
_932783
650 2 4 _aSecurity Science and Technology.
_931884
650 2 4 _aBiotechnology.
_97533
650 2 4 _aMedical Law.
_946049
700 1 _aBadnjević, Almir.
_eeditor.
_4edt
_4http://id.loc.gov/vocabulary/relators/edt
_946050
700 1 _aCifrek, Mario.
_eeditor.
_4edt
_4http://id.loc.gov/vocabulary/relators/edt
_946051
700 1 _aMagjarević, Ratko.
_eeditor.
_4edt
_4http://id.loc.gov/vocabulary/relators/edt
_946052
700 1 _aDžemić, Zijad.
_eeditor.
_4edt
_4http://id.loc.gov/vocabulary/relators/edt
_946053
710 2 _aSpringerLink (Online service)
_946054
773 0 _tSpringer Nature eBook
776 0 8 _iPrinted edition:
_z9789811066498
776 0 8 _iPrinted edition:
_z9789811066511
776 0 8 _iPrinted edition:
_z9789811349232
830 0 _aSeries in Biomedical Engineering,
_x1864-5771
_946055
856 4 0 _uhttps://doi.org/10.1007/978-981-10-6650-4
912 _aZDB-2-ENG
912 _aZDB-2-SXE
942 _cEBK
999 _c77789
_d77789