Biomaterials, medical devices, and combination products : (Record no. 50320)

000 -LEADER
fixed length control field 03307cam a2200457Ii 4500
001 - CONTROL NUMBER
control field 9781482248388
003 - CONTROL NUMBER IDENTIFIER
control field FlBoTFG
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20190209161040.0
006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS
fixed length control field m o d
007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION
fixed length control field cr cn
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 170311t20162016flua ob 001 0 eng d
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9781482248388 (e-book : PDF)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9781482248371 (hardback)
035 ## - SYSTEM CONTROL NUMBER
System control number (OCoLC)929952154
038 ## - RECORD CONTENT LICENSOR
Record content licensor 200
040 ## - CATALOGING SOURCE
Original cataloging agency FlBoTFG
Language of cataloging eng
Description conventions rda
Transcribing agency FlBoTFG
090 ## - LOCALLY ASSIGNED LC-TYPE CALL NUMBER (OCLC); LOCAL CALL NUMBER (RLIN)
Classification number (OCLC) (R) ; Classification number, CALL (RLIN) (NR) R857.M3
Local cutter number (OCLC) ; Book number/undivided call number, CALL (RLIN) G33 2016
092 ## - LOCALLY ASSIGNED DEWEY CALL NUMBER (OCLC)
Classification number 610.284
Item number G123
100 1# - MAIN ENTRY--PERSONAL NAME
Personal name Gad, Shayne C.,
Dates associated with a name 1948-
Relator term author.
9 (RLIN) 128633
240 10 - UNIFORM TITLE
Uniform title Safety evaluation in the development of medical devices combination products
245 10 - TITLE STATEMENT
Title Biomaterials, medical devices, and combination products :
Remainder of title biocompatibility testing and safety assessment /
Statement of responsibility, etc. Shayne Cox Gad, Gad Consulting Services, Cary, North Carolina, USA, Samantha Gad-McDonald, Gad Consulting Services, Cary, North Carolina, USA.
264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE
Place of production, publication, distribution, manufacture Boca Raton :
Name of producer, publisher, distributor, manufacturer CRC Press, Taylor & Francis Group,
Date of production, publication, distribution, manufacture, or copyright notice [2016]
264 #4 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE
Date of production, publication, distribution, manufacture, or copyright notice ?2016
300 ## - PHYSICAL DESCRIPTION
Extent 1 online resource (xxii, 584 pages) :
Other physical details illustrations
336 ## - CONTENT TYPE
Content type term text
Source rdacontent
337 ## - MEDIA TYPE
Media type term computer
Source rdamedia
338 ## - CARRIER TYPE
Carrier type term online resource
Source rdacarrier
500 ## - GENERAL NOTE
General note ebook
500 ## - GENERAL NOTE
General note This is a completely revised and much expanded version of the third edition of Safety evaluation in the development of medical devices combination products.
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc. note Includes bibliographical references and index.
505 0# - FORMATTED CONTENTS NOTE
Formatted contents note chapter 1. Safety evaluation of medical devices -- chapter 2. Regulatory aspects and strategy in medical device and biomaterials safety evaluation -- chapter 3. Road map to test selections -- chapter 4. Materials in medical device design -- chapter 5. What to test : sampling and sample preparation -- chapter 6. Cytotoxicity testing -- chapter 7. Hemocompatibility (ISO 10993-4) -- chapter 8. Local tissue tolerance -- chapter 9. Immunotoxicology (ISO 10993-20) -- chapter 10. Implantation biology and studies -- chapter 11. Acute systemic toxicity testing and device safety evaluation -- chapter 12. Genotoxicity -- chapter 13. Subchronic and chronic toxicity and reproductive and developmental toxicity -- chapter 14. Carcinogenicity -- chapter 15. Degradation products and impurities : processes in medical devices -- chapter 16. Special case devices -- chapter 17. Combination products -- chapter 18. Clinical studies for medical devices -- chapter 19. Leachables and extractables from medical devices -- chapter 20. Toxicokinetics in biomaterial and device safety evaluation -- chapter 21. Special studies -- chapter 22. Case histories and problem resolution.
518 ## - DATE/TIME AND PLACE OF AN EVENT NOTE
Date/time and place of an event note YE2019 M02
530 ## - ADDITIONAL PHYSICAL FORM AVAILABLE NOTE
Additional physical form available note Also available in print format.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Biomedical materials
General subdivision Biocompatibility
-- Testing.
9 (RLIN) 121992
655 #7 - INDEX TERM--GENRE/FORM
Genre/form data or focus term Electronic books.
Source of term lcsh
9 (RLIN) 9004
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Gad-McDonald, Samantha,
Relator term author.
9 (RLIN) 121993
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Gad, Shayne C.,
Dates associated with a name 1948-
Title of a work Safety evaluation in the development of medical devices combination products.
Version 3rd ed.
9 (RLIN) 121994
776 08 - ADDITIONAL PHYSICAL FORM ENTRY
Relationship information Print version:
International Standard Book Number 9781482248371 (hardback : alk. paper)
-- 1482248379 (hardback : alk. paper)
856 40 - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier https://www.taylorfrancis.com/books/9781482248388
Electronic format type application/PDF
Public note Distributed by publisher. Purchase or institutional license may be required for access.
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Source of classification or shelving scheme
Koha item type Electronic file

No items available.