Significant and Nonsignificant Risk Medical Devices (Record no. 62126)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 04438nam a22005895i 4500 |
| 001 - CONTROL NUMBER | |
| control field | 978-3-031-52838-5 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | DE-He213 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20251030112704.0 |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr nn 008mamaa |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 240801s2024 sz | s |||| 0|eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9783031528385 |
| -- | 978-3-031-52838-5 |
| 024 7# - OTHER STANDARD IDENTIFIER | |
| Standard number or code | 10.1007/978-3-031-52838-5 |
| Source of number or code | doi |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| 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 |
| 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 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Place of production, publication, distribution, manufacture | Cham : |
| Name of producer, publisher, distributor, manufacturer | Springer Nature Switzerland : |
| -- | Imprint: Springer, |
| Date of production, publication, distribution, manufacture, or copyright notice | 2024. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | VIII, 433 p. 87 illus., 66 illus. in color. |
| Other physical details | online resource. |
| 336 ## - CONTENT TYPE | |
| Content type term | text |
| Content type code | txt |
| Source | rdacontent |
| 337 ## - MEDIA TYPE | |
| Media type term | computer |
| Media type code | c |
| Source | rdamedia |
| 338 ## - CARRIER TYPE | |
| Carrier type term | online resource |
| Carrier type code | cr |
| Source | rdacarrier |
| 347 ## - DIGITAL FILE CHARACTERISTICS | |
| File type | text file |
| Encoding format | |
| Source | 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. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| General subdivision | Research. |
| 9 (RLIN) | 62598 |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| General subdivision | Research. |
| 9 (RLIN) | 65629 |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| General subdivision | Research. |
| 9 (RLIN) | 74123 |
| 650 14 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 9 (RLIN) | 65633 |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 9 (RLIN) | 74124 |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Timiri Shanmugam, Prakash Srinivasan. |
| Relator term | editor. |
| Authority record control number | (orcid)0000-0001-5927-3503 |
| -- | https://orcid.org/0000-0001-5927-3503 |
| Relator code | edt |
| -- | http://id.loc.gov/vocabulary/relators/edt |
| 9 (RLIN) | 81696 |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Thangaraju, Pugazhenthan. |
| Relator term | editor. |
| Relator code | edt |
| -- | http://id.loc.gov/vocabulary/relators/edt |
| 9 (RLIN) | 81697 |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Sampath, Thamizharasan. |
| Relator term | editor. |
| Relator code | edt |
| -- | http://id.loc.gov/vocabulary/relators/edt |
| 9 (RLIN) | 81698 |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Jagadeeswaran, Indumathy. |
| Relator term | editor. |
| Relator code | edt |
| -- | http://id.loc.gov/vocabulary/relators/edt |
| 9 (RLIN) | 81699 |
| 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 | |
| Uniform Resource Identifier | <a href="https://doi.org/10.1007/978-3-031-52838-5">https://doi.org/10.1007/978-3-031-52838-5</a> |
| 912 ## - | |
| -- | ZDB-2-ENG |
| 912 ## - | |
| -- | ZDB-2-SXE |
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