Medical devices : (Record no. 539964)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 05972cam a2200697Ii 4500 |
| 001 - CONTROL NUMBER | |
| control field | ocn918983953 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | OCoLC |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20180529115707.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 150820s2015 enka ob 001 0 eng d |
| 019 ## - | |
| -- | 918997444 |
| -- | 923544989 |
| -- | 929142538 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9780081002919 |
| Qualifying information | (electronic bk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 0081002912 |
| Qualifying information | (electronic bk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Cancelled/invalid ISBN | 9780081002896 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Cancelled/invalid ISBN | 0081002890 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (OCoLC)918983953 |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | DLC |
| Language of cataloging | eng |
| Transcribing agency | DLC |
| Modifying agency | AU |
| 049 ## - LOCAL HOLDINGS (OCLC) | |
| Holding library | Alfaisal Main Library |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | R856 |
| 060 #4 - NATIONAL LIBRARY OF MEDICINE CALL NUMBER | |
| Classification number | W 26 |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Ramakrishna, Seeram, |
| Relator term | author. |
| 245 10 - TITLE STATEMENT | |
| Title | Medical devices : |
| Remainder of title | regulations, standards and practices / |
| Statement of responsibility, etc | Seeram Ramakrishna, Lingling Tian, Charlene Wang, Susan Liao and Wee Eong Teo. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE STATEMENTS | |
| Place of production, publication, distribution, manufacture | Cambridge : |
| Name of producer, publisher, distributor, manufacturer | Woodhead Publishing, an imprint of Elsevier, |
| Date of production, publication, distribution, manufacture | [2015] |
| 264 #4 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE STATEMENTS | |
| Date of production, publication, distribution, manufacture | ©2015 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) | |
| Date of publication, distribution, etc | [2015] |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 1 online resource : |
| Other physical details | color illustrations. |
| 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 |
| 490 1# - SERIES STATEMENT | |
| Series statement | Woodhead Publishing series in biomaterials ; |
| Volume number/sequential designation | number 103 |
| 588 0# - | |
| -- | Online resource; title from PDF title page (EBSCO, viewed August 21, 2015). |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE | |
| Bibliography, etc | Includes bibliographical references and index. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc | Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors' practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | ""Front Cover""; ""Medical Devices: Regulations, Standards and Practices""; ""Copyright""; ""Contents""; ""List of contributors""; ""Woodhead Publishing Series in Biomaterials""; ""Chapter 1: Introduction""; ""1.1. Medical devices: definitions and types""; ""1.2. Market trend""; ""1.3. Safety issues""; ""1.4. The development of regulations and standards""; ""1.5. The structure of this book""; ""FAQs""; ""Part One: Regulations and standards""; ""Chapter 2: General regulations of medical devices""; ""2.1. Introduction""; ""2.2. The United States"" |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | ""2.2.1. The regulatory authority for medical devices and its organization in the United States""""2.2.2. Classification of medical devices and the relevant controls in the United States""; ""2.2.3. Practical guide to identifying the medical devices classification in the United States""; ""2.3. The European Union""; ""2.3.1. Regulatory framework for medical devices in the EU""; ""2.3.2. New changes in EU regulation""; ""2.3.3. Differences between the regulations for medical devices in the United States and the EU""; ""2.4. China"" |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | ""2.4.1. The regulatory framework for medical devices in China""""2.4.2. Changes in Chinese regulations""; ""2.4.2.1. The evolution of CFDA""; ""2.4.2.2. Revised regulation on the supervision and administration of medical devices""; ""2.5. Japan""; ""2.6. Australia""; ""2.7. India""; ""2.8. Singapore""; ""2.8.1. Regulatory framework for medical devices in Singapore""; ""2.8.2. Grouping of medical devices for production registration in Singapore""; ""2.9. Conclusions""; ""FAQs""; ""Chapter 3: Quality management systems for medical device manufacture""; ""3.1. Introduction"" |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | ""3.1.1. History of QSR 21 CFR 820""""3.1.2. History of ISO 13485""; ""3.2. ISO 13485:2012""; ""3.2.1. General requirements of ISO 13485: 2012""; ""3.2.2. Document control required by ISO 13485:2012""; ""3.2.2.1. Quality manual""; ""3.2.2.2. Control of documents""; ""3.2.2.3. Control of records""; ""3.2.3. Processes required by ISO 13485""; ""3.2.3.1. Implementation""; ""3.2.3.2. Process effectiveness""; ""3.2.4. Conformity assessment, registration, and certification processes""; ""3.2.4.1. Conformity assessment""; ""3.2.4.2. Certification"" |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | ""3.2.5. ISO 13485 application in various countries""""3.2.5.1. EU""; ""3.2.5.2. Canada""; ""3.2.5.3. Japan""; ""3.3. Current good manufacturing practice""; ""3.4. The difference between ISO 13485 and cGMP""; ""3.5. Conclusions""; ""FAQs""; ""Chapter 4: The process of gaining approval for new medical devices""; ""4.1. Introduction""; ""4.2. The United States""; ""4.2.1. Step 1: Classify device""; ""4.2.2. Step 2: Choose correct premarket submission""; ""4.2.3. Step 3: Prepare documents for submission to the FDA""; ""4.2.3.1. Class I process""; ""4.2.3.2. Class II process-510(k)"" |
| 590 ## - LOCAL NOTE (RLIN) | |
| Local note | Elsevier |
| Provenance (VM) [OBSOLETE] | ScienceDirect All Books |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Medical instruments and apparatus. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Surgical instruments and apparatus. |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | HEALTH & FITNESS |
| General subdivision | Holism. |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | HEALTH & FITNESS |
| General subdivision | Reference. |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | MEDICAL |
| General subdivision | Alternative Medicine. |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | MEDICAL |
| General subdivision | Atlases. |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | MEDICAL |
| General subdivision | Essays. |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | MEDICAL |
| General subdivision | Family & General Practice. |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | MEDICAL |
| General subdivision | Holistic Medicine. |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | MEDICAL |
| General subdivision | Osteopathy. |
| Source of heading or term | bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Medical instruments and apparatus. |
| Source of heading or term | fast |
| -- | (OCoLC)fst01014194 |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Surgical instruments and apparatus. |
| Source of heading or term | fast |
| -- | (OCoLC)fst01139450 |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Equipment and Supplies |
| General subdivision | standards. |
| 655 #7 - INDEX TERM--GENRE/FORM | |
| Genre/form data or focus term | Electronic books. |
| Source of term | local |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Tian, Lingling, |
| Relator term | author. |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Wang, Charlene, |
| Relator term | author. |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Liao, Susan, |
| Relator term | author. |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Teo, Wee Eong, |
| Relator term | author. |
| 710 2# - ADDED ENTRY--CORPORATE NAME | |
| Corporate name or jurisdiction name as entry element | ScienceDirect eBooks. |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Display text | Print version: |
| Main entry heading | Ramakrishna, Seeram. |
| Title | Medical Devices : Regulations, Standards and Practices. |
| Place, publisher, and date of publication | : Elsevier Science, ©2015 |
| International Standard Book Number | 9780081002896 |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE | |
| Uniform title | Woodhead Publishing series in biomaterials ; |
| Volume number/sequential designation | no. 103. |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="http://ezproxy.alfaisal.edu/login?url=https://www.sciencedirect.com/science/book/9780081002896">http://ezproxy.alfaisal.edu/login?url=https://www.sciencedirect.com/science/book/9780081002896</a> |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Library of Congress Classification |
| Koha item type | eBooks |
No items available.