國立高雄大學圖資館 |

Language: English

Back

Significant and nonsignificant risk medical devices

Record Type:	Electronic resources : Monograph/item
Title/Author:	Significant and nonsignificant risk medical devicesedited by Prakash Srinivasan Timiri Shanmugam ... [et al.].
other author:	Shanmugam, Prakash Srinivasan Timiri.
Published:	Cham :Springer Nature Switzerland :2024.
Description:	viii, 433 p. :ill. (chiefly col.), digital ;24 cm.
Contained By:	Springer Nature eBook
Subject:	Medical instruments and apparatus.
Online resource:	https://doi.org/10.1007/978-3-031-52838-5
ISBN:	9783031528385$q(electronic bk.)

Significant and nonsignificant risk medical devices
Significant and nonsignificant risk medical devices[electronic resource] /edited by Prakash Srinivasan Timiri Shanmugam ... [et al.]. - Cham :Springer Nature Switzerland :2024. - viii, 433 p. :ill. (chiefly col.), digital ;24 cm.

Chapter 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.

This 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.

ISBN: 9783031528385$q(electronic bk.)

Standard No.: 10.1007/978-3-031-52838-5doiSubjects--Topical Terms:

225233
Medical instruments and apparatus.

LC Class. No.: R856

Dewey Class. No.: 610.28

Significant and nonsignificant risk medical devices
LDR:02968nmm a2200325 a 4500 001 667012
003 DE-He213
005 20240802094815.0
006 m d
007 cr nn 008maaau
008 250107s2024 sz s 0 eng d
020 $a 9783031528385$q(electronic bk.)
020 $a 9783031528378$q(paper)
024 7 $a 10.1007/978-3-031-52838-5 $2 doi
035 $a 978-3-031-52838-5
040 $a GP $c GP
041 0 $a eng
050 4 $a R856
072 7 $a MQW $2 bicssc
072 7 $a TEC059000 $2 bisacsh
072 7 $a MQW $2 thema
082 0 4 $a 610.28 $2 23
090 $a R856 $b .S578 2024
245 0 0 $a Significant and nonsignificant risk medical devices $h [electronic resource] / $c edited by Prakash Srinivasan Timiri Shanmugam ... [et al.].
260 $a Cham : $b Springer Nature Switzerland : $b Imprint: Springer, $c 2024.
300 $a viii, 433 p. : $b ill. (chiefly col.), digital ; $c 24 cm.
505 0 $a Chapter 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 $a This 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.
650 0 $a Medical instruments and apparatus. $3 225233
650 0 $a Medical instruments and apparatus $x Risk assessment. $3 979772
650 1 4 $a Biomedical Engineering and Bioengineering. $3 826326
650 2 4 $a Biomedical Research. $3 243625
650 2 4 $a Biomedical Devices and Instrumentation. $3 921025
650 2 4 $a Medical and Health Technologies. $3 921447
650 2 4 $a Clinical Research. $3 911843
700 1 $a Shanmugam, Prakash Srinivasan Timiri. $3 903233
710 2 $a SpringerLink (Online service) $3 273601
773 0 $t Springer Nature eBook
856 4 0 $u https://doi.org/10.1007/978-3-031-52838-5
950 $a Engineering (SpringerNature-11647)