MARC details
| 000 -LEADER |
|---|
| fixed length control field |
04209nam a22005295i 4500 |
| 003 - CONTROL NUMBER IDENTIFIER |
|---|
| control field |
TR-AnTOB |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20231121132613.0 |
| 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 |
220422s2022 sz | s |||| 0|eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9783030918552 |
| 024 7# - OTHER STANDARD IDENTIFIER |
|---|
| Standard number or code |
10.1007/978-3-030-91855-2 |
| Source of number or code |
doi |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
TR-AnTOB |
| Language of cataloging |
eng |
| Description conventions |
rda |
| Transcribing agency |
TR-AnTOB |
| 041 ## - LANGUAGE CODE |
|---|
| Language code of text/sound track or separate title |
İngilizce |
| 060 ## - NATIONAL LIBRARY OF MEDICINE CALL NUMBER |
|---|
| Classification number |
W 26 |
| 072 #7 - SUBJECT CATEGORY CODE |
|---|
| Subject category code |
MQW |
| Source |
bicssc |
|
|---|
| Subject category code |
TEC059000 |
| Source |
bisacsh |
|
|---|
| Subject category code |
MQW |
| Source |
thema |
| 096 ## - LOCALLY ASSIGNED NLM-TYPE CALL NUMBER (OCLC) |
|---|
| Classification number |
W26EBK |
| 245 10 - TITLE STATEMENT |
|---|
| Title |
Medical Device Guidelines and Regulations Handbook |
| Medium |
[electronic resource] / |
| Statement of responsibility, etc. |
edited by Prakash Srinivasan Timiri Shanmugam, Pugazhenthan Thangaraju, Nandakumar Palani, Thamizharasan Sampath. |
| 250 ## - EDITION STATEMENT |
|---|
| Edition statement |
1st ed. 2022. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE |
|---|
| Place of production, publication, distribution, manufacture |
Cham : |
| Name of producer, publisher, distributor, manufacturer |
Springer International Publishing : |
| -- |
Imprint: Springer, |
| Date of production, publication, distribution, manufacture, or copyright notice |
2022. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
1 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 |
PDF |
| Source |
rda |
| 505 0# - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
Guidelines -- ISO 10993 – Biological Evaluation of Medical Devices -- ISO 22442 – Medical Devices utilizing Animal Tissues and Their Derivatives -- ISO 14971 & 24971 – Medical Device Risk Management -- ISO 21534 – Non-Active Surgical Implants – Joint replacement implants -- ISO 16061 Instrumentation for Use in Association with Non-Active Surgical Implants -- ISO 13485 – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes -- ISO 19227- Implants for Surgery – Cleanliness of Orthopedic implants -- ISO 14155 - Clinical Investigation of Medical Devices for Human Subjects -- ISO 11607 - Packaging for Terminally Sterilized Medical Devices -- ISO 11137 -1, 2 and 3 - Sterilization of Health Care Products -- ISO 11135 - Sterilization of Health Care Products —Ethylene Oxide — Requirements for development, validation and routine control of a sterilization process for medical devices -- ISO 17665-1 - Sterilization of Health Care Products — Moist Heat -- Regulations -- FDA- CFR Title 21 - Food and Drugs: Parts 800 to 1299 -- Global Medical Device Regulations (covering various individual countries) -- EU 722/2012 – Animal Tissue Regulations in Effect for Some Medical Devices -- EU 2017/746 – In Vitro Diagnostic Medical Devices -- EU 1097/2006 - REACH. |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc. |
This comprehensive resource features in-depth discussions of important guidelines and regulations you will need to understand and properly meet medical device code-related requirements. Focusing on the practical application of the regulations, the Medical Device Guidelines and Regulations Handbook delivers clear explanations, real-world examples, and annotation on the applicable provisions that will allow you to safely and confidently choose materials and processes for medical device development, testing, and manufacturing. A critical resource for researchers and professionals in the medical device field; Thoroughly covers ISO 10993, ISO 22442, ISO 14971, ISO 13485, ISO 21534, REACH, RoHS, CLP, EU MDR; Presents simplified guidelines and regulation points. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Biomedical engineering. |
|
|---|
| Topical term or geographic name entry element |
Biomedical Engineering and Bioengineering. |
|
|---|
| Topical term or geographic name entry element |
Biomedical Devices and Instrumentation. |
|
|---|
| Topical term or geographic name entry element |
Medical and Health Technologies. |
| 653 #0 - INDEX TERM--UNCONTROLLED |
|---|
| Uncontrolled term |
Equipment and Supplies -- standards |
|
|---|
| Uncontrolled term |
Equipment Design -- standards |
|
|---|
| Uncontrolled term |
Materials Testing -- standards |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Timiri Shanmugam, Prakash Srinivasan. |
| Relator term |
editor. |
| Authority record control number or standard number |
(orcid)0000-0001-5927-3503 |
| Relator code |
edt |
| -- |
http://id.loc.gov/vocabulary/relators/edt |
|
|---|
| Personal name |
Thangaraju, Pugazhenthan. |
| Relator term |
editor. |
| Relator code |
edt |
| -- |
http://id.loc.gov/vocabulary/relators/edt |
|
|---|
| Personal name |
Palani, Nandakumar. |
| Relator term |
editor. |
| Relator code |
edt |
| -- |
http://id.loc.gov/vocabulary/relators/edt |
|
|---|
| Personal name |
Sampath, Thamizharasan. |
| 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) |
| 856 40 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Uniform Resource Identifier |
<a href="https://doi.org/10.1007/978-3-030-91855-2">https://doi.org/10.1007/978-3-030-91855-2</a> |
| Materials specified |
Springer eBooks |
| Public note |
Online access link to the resource |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Source of classification or shelving scheme |
National Library of Medicine |
| Koha item type |
E-Book |
