000 04452nam a22006015i 4500
001 978-3-031-52838-5
003 DE-He213
005 20250516160114.0
007 cr nn 008mamaa
008 240801s2024 sz | s |||| 0|eng d
020 _a9783031528385
_9978-3-031-52838-5
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 _aSignificant and Nonsignificant Risk Medical Devices
_h[electronic resource] /
_cedited by Prakash Srinivasan Timiri Shanmugam, Pugazhenthan Thangaraju, Thamizharasan Sampath, Indumathy Jagadeeswaran.
250 _a1st ed. 2024.
264 1 _aCham :
_bSpringer Nature Switzerland :
_bImprint: Springer,
_c2024.
300 _aVIII, 433 p. 87 illus., 66 illus. in color.
_bonline resource.
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _atext file
_bPDF
_2rda
505 0 _aChapter 1. INTRODUCTION -- Chapter 2. GENERAL MEDICAL USE -- Chapter 3. ANAESTHESIOLOGY -- Chapter 4. SIGNIFICANT AND NONSIGNIFICANT RISK CARDIOVASCULAR DEVICES -- Chapter 5. Significant Risk Dental Devices -- Chapter 6. Significant Risk Medical Devices- ENT (Ear, Nose & Throat) -- Chapter 7. Advantages and Disadvantages of Gastroenterology and Urology Implants -- Chapter 8. Significant and non-significant risks of General and Plastic Surgery devices -- Chapter 9. General Hospital Devices -- Chapter 10. SIGNIFICANT RISK MEDICAL DEVICES NEUROLOGY -- Chapter 11. OBSTETRICS AND GYNECOLOGY INSTRUMENTS -- Chapter 12. Medical Devices-Ophthalmic Devices -- Chapter 13. ORTHOPEDICS -- Chapter 14. RADIOLOGY -- Chapter 15. Non Significant Risk Medical Devices.
520 _aThis comprehensive resource explains the FDA's classification of devices and provides expert guidance on differentiating between significant risk and non-significant risk medical device studies. The book is divided into two parts: Significant Risk Medical Devices and Non-Significant Risk Medical Devices. Each chapter includes a general introduction and overview of the device, along with guidance on its working principles, beneficial and toxicological effects, and potential risks to the health and safety of a patient/subject. The coverage also includes reports of prior investigations on the basics of risk determination and the nature of potential harm associated with using individual devices. Significant and Non-Significant Risk Medical Devices is designed to assist practicing engineers, academic researchers, and clinical investigators in navigating the complex regulatory environment associated with medical device research and development. An essential resource for researchers and professionals in the medical device field; Thoroughly covers the distinctions between Significant Risk (SR) and Non-Significant Risk (NSR) device studies; Presents simplified guidelines and regulatory points.
541 _fUABC ;
_cPerpetuidad
650 0 _aBiomedical engineering.
650 0 _aMedicine
_xResearch.
650 0 _aBiology
_xResearch.
650 0 _aClinical medicine
_xResearch.
650 1 4 _aBiomedical Engineering and Bioengineering.
650 2 4 _aBiomedical Research.
650 2 4 _aBiomedical Devices and Instrumentation.
650 2 4 _aMedical and Health Technologies.
650 2 4 _aClinical Research.
700 1 _aTimiri Shanmugam, Prakash Srinivasan.
_eeditor.
_0(orcid)0000-0001-5927-3503
_1https://orcid.org/0000-0001-5927-3503
_4edt
_4http://id.loc.gov/vocabulary/relators/edt
700 1 _aThangaraju, Pugazhenthan.
_eeditor.
_4edt
_4http://id.loc.gov/vocabulary/relators/edt
700 1 _aSampath, Thamizharasan.
_eeditor.
_4edt
_4http://id.loc.gov/vocabulary/relators/edt
700 1 _aJagadeeswaran, Indumathy.
_eeditor.
_4edt
_4http://id.loc.gov/vocabulary/relators/edt
710 2 _aSpringerLink (Online service)
773 0 _tSpringer Nature eBook
776 0 8 _iPrinted edition:
_z9783031528378
776 0 8 _iPrinted edition:
_z9783031528392
776 0 8 _iPrinted edition:
_z9783031528408
856 4 0 _zLibro electrónico
_uhttp://libcon.rec.uabc.mx:2048/login?url=https://doi.org/10.1007/978-3-031-52838-5
912 _aZDB-2-ENG
912 _aZDB-2-SXE
942 _cLIBRO_ELEC
999 _c275884
_d275883