MARC details
| 000 -LEADER |
|---|
| fixed length control field |
04048cam a2200373 i 4500 |
| 001 - CONTROL NUMBER |
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| control field |
on1228035595 |
| 003 - CONTROL NUMBER IDENTIFIER |
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| control field |
OCoLC |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
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| control field |
20240726104831.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
201226s2021 onc ob 001 0 eng d |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
EBLCP |
| Language of cataloging |
eng |
| Description conventions |
rda |
| Transcribing agency |
EBLCP |
| Modifying agency |
UKAHL |
| -- |
OCLCQ |
| -- |
NT |
| -- |
YDX |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| International Standard Book Number |
9781774078235 |
| 050 04 - LIBRARY OF CONGRESS CALL NUMBER |
|---|
| Classification number |
K3611 |
| Item number |
.S567 2021 |
| 049 ## - LOCAL HOLDINGS (OCLC) |
|---|
| Holding library |
MAIN |
| 100 1# - MAIN ENTRY--PERSONAL NAME |
|---|
| Personal name |
Naidoo, Shalinee, |
| Relator term |
Author |
| 245 10 - TITLE STATEMENT |
|---|
| Title |
A simple guide to understanding medical device regulations /Shalinee Naidoo. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
1 online resource (xxii, 243 pages) |
| 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 |
data file |
| Source |
rda |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
|---|
| Bibliography, etc. note |
Includes bibliographies and index. |
| 505 00 - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
Chapter 1 Introduction -- |
| Title |
Chapter 2 What is a Medical Device? -- |
| -- |
Chapter 3 Classification of Medical Devices -- |
| -- |
3.1. Factors Influencing Device Classification Schemes -- |
| -- |
3.2. Initial Classification Rules As Defined By The Global Harmonization Task Force -- |
| -- |
3.3. Eu Guidelines On Medical Device Classification -- |
| -- |
3.4. Understanding How To Apply The Rules Of Medical Device Classification |
| 505 00 - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
3.5. How To Apply The Eu Medical Device Classification Rules -- |
| Title |
3.6. Understanding The Rules Governing Guidelines For The Classification Of Medical Devices According To Meddev 2.4/1 -- |
| -- |
Chapter 4 History of Medical Device Regulations -- |
| -- |
Chapter 5 Understanding the 2001 Model Regulatory Program for Medical Devices as Laid Out By WHO -- |
| -- |
5.1. Understanding Section I: Guiding Principles And Essential Features Of A Regulatory Program For Medical Devices -- |
| -- |
5.2. Understanding Section Ii: A Modular Approach To A Regulatory Program For Medical Devices |
| 505 00 - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
5.3. Understanding Section Iii: Reuse of Medical Devices -- |
| Title |
Chapter 6 Safety of Medical Devices -- |
| -- |
6.1. How Do We Ensure Safety of Medical Devices? -- |
| -- |
6.2. Safety In Relation To Performance Of A Medical Device -- |
| -- |
Chapter 7 Assessing The Effectiveness/Performance Of Medical Devices -- |
| -- |
7.1. Participants In Ensuring The Safety of Medical Devices -- |
| -- |
7.2. Understanding The Role Of Each Participant -- |
| -- |
7.3. Shared Responsibilities For Safety And Performance of Medical Devices -- |
| -- |
Chapter 8 Conformity Assessments of Medical Devices -- |
| -- |
8.1. Quality Management System (QMS) |
| 505 00 - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
8.2. System For Post-Market Surveillance -- |
| Title |
8.3. Technical Documentation -- |
| -- |
8.4. Declaration Of Conformity -- |
| -- |
8.5. Registration Of Manufacturers And Their Medical Devices by The Regulatory Authority -- |
| -- |
Chapter 9 Understanding Sted (Summary Technical Documentation) -- |
| -- |
9.1. What Is The Purpose Of Sted? -- |
| -- |
9.2. The Use Of Sted In The Premarket Phase -- |
| -- |
9.3. The Use Of The Sted In The Post-Market Phase -- |
| -- |
9.4. Contents Of Sted -- |
| -- |
Chapter 10 Standards -- |
| -- |
10.1. What Are Standards? -- |
| -- |
10.2. Types Of Standard Specifications -- |
| -- |
10.3. The Purpose Of Standards -- |
| -- |
10.4. Types Of Standards |
| 505 00 - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
10.5. Development Process Of Standards -- |
| Title |
10.6. Key Principles In The Development Of Iso Standards (As Defined By ISO) -- |
| -- |
10.7. Conformity Assessment With Standards -- |
| -- |
10.8. National And International Standard Systems -- |
| -- |
10.9. Identification Of Standards -- |
| -- |
10.10. The Use Of Standards In Medical Device Regulations -- |
| -- |
Chapter 11 The Global Harmonized Task Force -- |
| -- |
Chapter 12 Nomenclature Of Medical Devices -- |
| -- |
12.1. The Global Medical Devices Nomenclature System -- |
| -- |
12.2. Development Of GMDN -- |
| -- |
12.3. Understanding The Purpose Of GMDN -- |
| -- |
12.4. Compilation Of The Initial GMDN Nomenclature Database -- |
| -- |
12.5. Understanding The Structure Of The Global Medical Device Nomenclature System. |
| 530 ## - COPYRIGHT INFORMATION: |
|---|
| COPYRIGHT INFORMATION |
COPYRIGHT NOT covered - Click this link to request copyright permission: |
| Uniform Resource Identifier |
<a href="b">b</a> |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Medical instruments and apparatus |
| General subdivision |
Safety regulations. |
| 655 #1 - INDEX TERM--GENRE/FORM |
|---|
| Genre/form data or focus term |
Electronic Books. |
| 856 40 - ELECTRONIC LOCATION AND ACCESS |
|---|
| -- |
Click to access digital title | log in using your CIU ID number and my.ciu.edu password. |
| Uniform Resource Identifier |
<a href="httpss://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=2713644&site=eds-live&custid=s3260518">httpss://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=2713644&site=eds-live&custid=s3260518</a> |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Koha item type |
Online Book (LOGIN USING YOUR MY CIU LOGIN AND PASSWORD) |
| DONATED BY: |
|
| VENDOR |
EBSCO |
| Classification part |
K. |
| PUBLICATION YEAR |
2021 |
| LOCATION |
ONLINE |
| REQUESTED BY: |
|
| -- |
|
| -- |
NFIC |
| Source of classification or shelving scheme |
|
| 994 ## - |
|---|
| -- |
92 |
| -- |
NT |
| 902 ## - LOCAL DATA ELEMENT B, LDB (RLIN) |
|---|
| a |
1 |
| b |
Cynthia Snell |
| c |
1 |
| d |
Cynthia Snell |