MARC details
| 000 -LIDER |
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| fixed length control field |
04452nam a22006015i 4500 |
| 001 - CONTROL NUMBER |
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| control field |
978-3-031-52838-5 |
| 003 - CONTROL NUMBER IDENTIFIER |
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| control field |
DE-He213 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
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| control field |
20250516160114.0 |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION |
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| fixed length control field |
cr nn 008mamaa |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
240801s2024 sz | s |||| 0|eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| International Standard Book Number |
9783031528385 |
| -- |
978-3-031-52838-5 |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER |
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| Classification number |
R856-857 |
| 072 #7 - SUBJECT CATEGORY CODE |
|---|
| Subject category code |
MQW |
| Source |
bicssc |
| 072 #7 - SUBJECT CATEGORY CODE |
|---|
| Subject category code |
TEC059000 |
| Source |
bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE |
|---|
| Subject category code |
MQW |
| Source |
thema |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Classification number |
610.28 |
| Edition number |
23 |
| 245 10 - TITLE STATEMENT |
|---|
| Title |
Significant and Nonsignificant Risk Medical Devices |
| Medium |
[electronic resource] / |
| Statement of responsibility, etc. |
edited by Prakash Srinivasan Timiri Shanmugam, Pugazhenthan Thangaraju, Thamizharasan Sampath, Indumathy Jagadeeswaran. |
| 250 ## - EDITION STATEMENT |
|---|
| Edition statement |
1st ed. 2024. |
| 264 #1 - |
|---|
| -- |
Cham : |
| -- |
Springer Nature Switzerland : |
| -- |
Imprint: Springer, |
| -- |
2024. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
VIII, 433 p. 87 illus., 66 illus. in color. |
| Other physical details |
online resource. |
| 336 ## - |
|---|
| -- |
text |
| -- |
txt |
| -- |
rdacontent |
| 337 ## - |
|---|
| -- |
computer |
| -- |
c |
| -- |
rdamedia |
| 338 ## - |
|---|
| -- |
online resource |
| -- |
cr |
| -- |
rdacarrier |
| 347 ## - |
|---|
| -- |
text file |
| -- |
PDF |
| -- |
rda |
| 505 0# - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
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 ## - SUMMARY, ETC. |
|---|
| Summary, etc. |
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. |
| 541 ## - IMMEDIATE SOURCE OF ACQUISITION NOTE |
|---|
| Owner |
UABC ; |
| Method of acquisition |
Perpetuidad |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Término temático o nombre geográfico como elemento de entrada |
Biomedical engineering. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Término temático o nombre geográfico como elemento de entrada |
Medicine |
| Subdivisión general |
Research. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Término temático o nombre geográfico como elemento de entrada |
Biology |
| Subdivisión general |
Research. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Término temático o nombre geográfico como elemento de entrada |
Clinical medicine |
| Subdivisión general |
Research. |
| 650 14 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Término temático o nombre geográfico como elemento de entrada |
Biomedical Engineering and Bioengineering. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Término temático o nombre geográfico como elemento de entrada |
Biomedical Research. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Término temático o nombre geográfico como elemento de entrada |
Biomedical Devices and Instrumentation. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Término temático o nombre geográfico como elemento de entrada |
Medical and Health Technologies. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Término temático o nombre geográfico como elemento de entrada |
Clinical Research. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Timiri Shanmugam, Prakash Srinivasan. |
| Relator term |
editor. |
| -- |
(orcid)0000-0001-5927-3503 |
| -- |
https://orcid.org/0000-0001-5927-3503 |
| Relator code |
edt |
| -- |
http://id.loc.gov/vocabulary/relators/edt |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Thangaraju, Pugazhenthan. |
| Relator term |
editor. |
| Relator code |
edt |
| -- |
http://id.loc.gov/vocabulary/relators/edt |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Sampath, Thamizharasan. |
| Relator term |
editor. |
| Relator code |
edt |
| -- |
http://id.loc.gov/vocabulary/relators/edt |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Jagadeeswaran, Indumathy. |
| Relator term |
editor. |
| Relator code |
edt |
| -- |
http://id.loc.gov/vocabulary/relators/edt |
| 710 2# - ADDED ENTRY--CORPORATE NAME |
|---|
| Corporate name or jurisdiction name as entry element |
SpringerLink (Online service) |
| 773 0# - HOST ITEM ENTRY |
|---|
| Title |
Springer Nature eBook |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
|---|
| Relationship information |
Printed edition: |
| International Standard Book Number |
9783031528378 |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
|---|
| Relationship information |
Printed edition: |
| International Standard Book Number |
9783031528392 |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
|---|
| Relationship information |
Printed edition: |
| International Standard Book Number |
9783031528408 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Public note |
Libro electrónico |
| Uniform Resource Identifier |
http://libcon.rec.uabc.mx:2048/login?url=https://doi.org/10.1007/978-3-031-52838-5 |
| 912 ## - |
|---|
| -- |
ZDB-2-ENG |
| 912 ## - |
|---|
| -- |
ZDB-2-SXE |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Koha item type |
Libro Electrónico |
