Atjaunināt sīkdatņu piekrišanu

E-grāmata: Applications of Polymers and Plastics in Medical Devices: Design, Manufacture, and Performance

(Senior Engineering Specialist, B. Braun Medical Inc., USA)
  • Formāts: PDF+DRM
  • Sērija : Plastics Design Library
  • Izdošanas datums: 09-Mar-2022
  • Izdevniecība: William Andrew Publishing
  • Valoda: eng
  • ISBN-13: 9780128217382
Citas grāmatas par šo tēmu:
  • Formāts - PDF+DRM
  • Cena: 236,68 €*
  • * ši ir gala cena, t.i., netiek piemērotas nekādas papildus atlaides
  • Ielikt grozā
  • Pievienot vēlmju sarakstam
  • Šī e-grāmata paredzēta tikai personīgai lietošanai. E-grāmatas nav iespējams atgriezt un nauda par iegādātajām e-grāmatām netiek atmaksāta.
Applications of Polymers and Plastics in Medical Devices: Design, Manufacture, and PerformancePalielināt
  • Formāts: PDF+DRM
  • Sērija : Plastics Design Library
  • Izdošanas datums: 09-Mar-2022
  • Izdevniecība: William Andrew Publishing
  • Valoda: eng
  • ISBN-13: 9780128217382
Citas grāmatas par šo tēmu:

DRM restrictions

  • Kopēšana (kopēt/ievietot):

    nav atļauts

  • Drukāšana:

    nav atļauts

  • Lietošana:

    Digitālo tiesību pārvaldība (Digital Rights Management (DRM))
    Izdevējs ir piegādājis šo grāmatu šifrētā veidā, kas nozīmē, ka jums ir jāinstalē bezmaksas programmatūra, lai to atbloķētu un lasītu. Lai lasītu šo e-grāmatu, jums ir jāizveido Adobe ID. Vairāk informācijas šeit. E-grāmatu var lasīt un lejupielādēt līdz 6 ierīcēm (vienam lietotājam ar vienu un to pašu Adobe ID).

    Nepieciešamā programmatūra
    Lai lasītu šo e-grāmatu mobilajā ierīcē (tālrunī vai planšetdatorā), jums būs jāinstalē šī bezmaksas lietotne: PocketBook Reader (iOS / Android)

    Lai lejupielādētu un lasītu šo e-grāmatu datorā vai Mac datorā, jums ir nepieciešamid Adobe Digital Editions (šī ir bezmaksas lietotne, kas īpaši izstrādāta e-grāmatām. Tā nav tas pats, kas Adobe Reader, kas, iespējams, jau ir jūsu datorā.)

    Jūs nevarat lasīt šo e-grāmatu, izmantojot Amazon Kindle.

Applications of Polymers and Plastics in Medical Devices: Design, Manufacture, and Performance is a comprehensive guide to plastic materials for medical devices, covering fundamentals, materials, applications and regulatory requirements. Sections cover the role of plastics in medical devices, socioeconomic factors, the classification of medical devices. The performance of, medical grades and suppliers of polymer materials, which are categorized by performance level are also explored, along with manufacturing processes for device components, including extrusion, casting, injection molding and assembly processes. The book then covers applications in detail, examining each device and the role that polymers and plastics play in its construction and function.

This is an essential resource for engineers, R&D, and other professionals working on plastics for medical devices and those in the plastics industry, medical device manufacturing, pharmaceuticals, packaging and biotechnology. In an academic setting, this book is of interest to researchers and advanced students in medical plastics, plastics engineering, polymer science, mechanical engineering, chemical engineering, biomedical engineering and materials science.

  • Offers systematic coverage of the major classes of polymers used in medical devices, including properties, characteristics, performance, medical grades and suppliers
  • Reviews regulatory requirements of the FDA and other global agencies, as well as considering quality control and socioeconomic factors
  • Includes the latest advances in plastics for medical devices, such as novel applications, use of bio-based polymers, and processing of reusable medical devices
Biography xi
Preface xiii
Acknowledgments xv
1 Introduction to polymers and plastics for medical devices
1(26)
1.1 History of medical devices
2(1)
1.2 What are medical devices
2(2)
1.3 Basic definitions
4(3)
1.4 Material used in medical devices
7(4)
1.5 Importance of plastics in medical devices
11(2)
1.6 General requirements of materials to qualify for medical devices
13(2)
1.7 Global nature of medical devices
15(1)
1.8 Socioeconomic factors
16(11)
References
22(5)
2 Classification of medical devices
27(18)
2.1 Role of Food and Drug Administration
27(1)
2.2 Classification of medical devices
28(5)
2.3 Why are devices classified?
33(1)
2.4 Device classification panels
33(1)
2.5 Exemptions
33(2)
2.6 Emergency use authorization
35(1)
2.7 Premarket notification, 510(k)
36(1)
2.8 Premarket approval
36(2)
2.9 Postapproval market requirements
38(2)
2.10 FDA's Accelerated Approval Program
40(1)
2.11 FDA's Breakthrough Devices Program
41(4)
References
42(3)
3 Selection of materials for construction of medical devices
45(20)
3.1 Overview of materials
45(4)
3.2 Material requirements for medical device qualification
49(16)
References
63(2)
4 Classification of plastics and elastomers used in medical devices
65(14)
4.1 Performance-based selection of plastics and elastomers for medical devices
66(4)
4.2 Plastics and elastomers used in FDA class I devices
70(9)
References
77(2)
5 Low performance demand plastics and elastomers for medical devices
79(12)
5.1 Introduction
79(1)
5.2 Polypropylene
80(2)
5.3 Polyethylene
82(3)
5.4 Polyvinyl chloride (PVC)
85(2)
5.5 Polystyrene
87(4)
References
89(2)
6 Medium-performance demand plastics and elastomers for medical devices
91(14)
6.1 Introduction
91(1)
6.2 Polycarbonate
92(3)
6.3 Polymethyl methacrylate
95(2)
6.4 Polybutylene terephthalate
97(1)
6.5 Polyphenylene oxide
98(2)
6.6 Acrylonitrile butadiene styrene
100(5)
References
102(3)
7 High-performance demand plastics and elastomers for medical devices
105(24)
7.1 Introduction
106(1)
7.2 Acetal copolymer
107(2)
7.3 Polyetheretherketone
109(3)
7.4 Polyphenyl Sulfone
112(1)
7.5 Polysulfone
113(2)
7.6 Polyphenylene sulfide
115(2)
7.7 Polyvinylidene fluoride
117(2)
7.8 Polyetherimide
119(2)
7.9 Polydimethylsiloxane
121(1)
7.10 Thermoplastic polyurethane
122(2)
7.11 Thermoplastic elastomer
124(5)
References
126(3)
8 Plastics fabrication techniques
129(18)
8.1 Machining of plastics
129(10)
8.2 Bonding
139(2)
8.3 Staking
141(2)
8.4 Two-part molding (silicone molding)
143(4)
References
144(3)
9 Plastic medical device manufacturing processes
147(16)
9.1 Introduction
147(1)
9.2 Extrusion
148(3)
9.3 Injection molding process
151(2)
9.4 Catheter manufacturing process
153(5)
9.5 Other secondary operations
158(5)
References
162(1)
10 Therapeutic applications of medical devices
163(46)
10.1 Biosurgery
164(5)
10.2 Cardiovascular heart rhythm
169(9)
10.3 Vascular surgery
178(7)
10.4 Interventional cardiology
185(6)
10.5 Thoracic drainage systems
191(2)
10.6 Prosthetic implants
193(4)
10.7 In vitro diagnostics
197(12)
References
203(6)
11 Applications of biobased polymers in medical devices
209(14)
11.1 Introduction
209(1)
11.2 Implantable medical devices
210(8)
11.3 Diagnostics and labware devices
218(1)
11.4 Healthcare electronic devices
218(1)
11.5 Medical mask and medical tubing
219(4)
References
219(4)
12 Regulatory requirements for medical devices
223(18)
12.1 Overview
223(1)
12.2 The Food and Drug Administration
224(9)
12.3 European Union Commission
233(1)
12.4 Other global agencies
234(4)
12.5 International Medical Device Regulators Forum
238(3)
References
239(2)
13 Market trends and global sourcing of medical devices
241(10)
13.1 Market trends toward increased safety and quality of medical devices
241(2)
13.2 Market trends in the medical device industry
243(2)
13.3 Global sourcing of plastics
245(6)
References
248(3)
14 Reprocessing of reusable medical devices
251(10)
14.1 Overview--reusable medical devices
251(1)
14.2 FDA guidance on reprocessing
252(1)
14.3 Factors affecting quality of reprocessing
253(2)
14.4 Cleaning validation--reusable medical devices
255(1)
14.5 Validation of the final microbicidal process
256(1)
14.6 Reusable medical device labeling
256(2)
14.7 Reprocessing of single-use medical devices
258(3)
References
259(2)
15 Economics and future direction of medical devices
261(16)
15.1 Understanding the economics of medical device cost
261(9)
15.2 Migration of device manufacturing, validation and use
270(7)
References
274(3)
Index 277
Dr. Syed Ali Ashter is the Founder of Ashter Enterprise, LLC, a material evaluation, product development and quality compliance consulting company, which he founded in 2020. He also works as a Senior Engineering Specialist at B. Braun Medical Inc. in Irvine California. He has served on the Board of Directors for the Society of Plastics Engineers Medical Plastics Division (MPD) since 2012. Recently, he has completed 2-year term as the chair of the Medical Plastics Division. He has authored four Plastics Engineering books in the Plastics Design Library Handbook Series.
Biežāk uzdotie jautājumi par e-grāmatām Biežāk uzdotie jautājumi par e-grāmatām
Permanent link: https://www.kriso.lv/db/97801282173822e.html
Keywords: