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Author: ASTM International
Publisher:
ISBN:
Category : Materials
Languages : en
Pages : 1540
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Book Description
Author: ASTM International
Publisher:
ISBN:
Category : Materials
Languages : en
Pages : 1540
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Book Description
Author: Shayne C. Gad
Publisher: CRC Press
ISBN: 9781439876084
Category : Medical
Languages : en
Pages : 576
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Book Description
Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field. The Third Edition explores these key current trends: global device markets continually advancing technology the increasing harmonization of device safety regulation worldwide Each aspect of safety evaluation is considered in terms of International Standards Organization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health and Welfare (MHW) perspectives. In addition, the book reflects the role of the continuing growth of technology in the incorporation of science, particularly in the areas of immunotoxicology and toxicokinetics.
Author: American Society for Testing and Materials
Publisher:
ISBN:
Category : Aggregates (Building materials)
Languages : en
Pages : 1586
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Book Description
Author: Kenneth R. St. John
Publisher: ASTM International
ISBN: 0803114419
Category : Biological interfaces
Languages : en
Pages : 215
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Book Description
The proceedings of an October 1990 symposium in San Antonio held to address the problem of the release of particulate material debris from medical implants because of wear, physical deterioration, or the harsh chemical environment. Examines tissue responses to such debris in order to identify factors that might moderate it, such as implant material or design, or postoperatic drugs. Member price, $53. Annotation copyrighted by Book News, Inc., Portland, OR
Author: Shayne Cox Gad
Publisher: CRC Press
ISBN: 1482248387
Category : Medical
Languages : en
Pages : 606
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Book Description
Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for-or concerned with-developing and ensuring patient safety in the use and manufacture of medical devices.The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical
Author: National Library of Medicine (U.S.)
Publisher:
ISBN:
Category : Medicine
Languages : en
Pages : 1028
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Book Description
Author: Shayne C. Gad
Publisher: CRC Press
ISBN: 1439809488
Category : Medical
Languages : en
Pages : 314
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Book Description
Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-l
Author: Shayne C. Gad
Publisher: Springer Nature
ISBN: 3030352412
Category : Medical
Languages : en
Pages : 496
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Book Description
While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation. Add to this that devices now frequently serve as delivery systems for drugs, and that drugs may be combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex. A part of this, requirements for ensuring safety (once based on use of previously acceptable materials – largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released). Then an appropriate and relevant (yet also conservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understand, and solve all of them. • Identify and verify the most appropriate available data. • As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest. • As the duration (and rate) of exposure to moieties released from a device are most frequently different (longer) than what available data speaks to, transformation across tissue is required. • As innate and adaptive immune responses are a central part of device/patient interaction, assessing potential risks on this basis are required. • Incorporating assessments for special populations such as neonates. • Use of (Q)SAR (Quantitative Structure Activity Relationships) modeling in assessments. • Performance and presentation of integrative assessments covering all potential biologic risks. Appendices will contain summarized available biocompatibility data for commonly used device materials (polymers and metals) and safety assessments on the frequently seen moieties in extractions from devices.
Author: National Library of Medicine (U.S.)
Publisher:
ISBN:
Category : Medicine
Languages : en
Pages : 1712
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Book Description
First multi-year cumulation covers six years: 1965-70.
Author: Sanjay Shrivastava
Publisher: ASM International
ISBN: 1615032606
Category : Medical
Languages : en
Pages : 536
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Book Description
In this proceedings volume, professionals from the medical device industry and their suppliers share technological and scientific knowledge, as well as insights into the latest innovations. The focus is on metallic materials, such as titanium alloys, Nitinol, cobalt-chromium alloys, stainless steels and noble metals, as applied in various medical devices. Topics range from orthopedics to orthodontics, materials selection to materials characterization. --
