Integrated Safety Assessment Report Integrated Safety Assessment Program

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Integrated Safety Assessment Report

Author : Anonim
Publisher : Unknown
Page : 128 pages
File Size : 52,8 Mb
Release : 1987
Category : Nuclear power plants
ISBN : OCLC:19957095

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Integrated Safety Assessment Report by Anonim Pdf

Integrated Safety and Risk Assessment for Medical Devices and Combination Products

Author : Shayne C. Gad
Publisher : Springer Nature
Page : 490 pages
File Size : 40,7 Mb
Release : 2020-02-24
Category : Medical
ISBN : 9783030352417

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Integrated Safety and Risk Assessment for Medical Devices and Combination Products by Shayne C. Gad Pdf

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.

News Releases

Author : Anonim
Publisher : Unknown
Page : 468 pages
File Size : 51,7 Mb
Release : 1987
Category : Nuclear energy
ISBN : STANFORD:36105216598206

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News Releases by Anonim Pdf

Energy Research Abstracts

Author : Anonim
Publisher : Unknown
Page : 906 pages
File Size : 52,9 Mb
Release : 1993
Category : Power resources
ISBN : MINN:30000006337335

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Energy Research Abstracts by Anonim Pdf

Semiannual, with semiannual and annual indexes. References to all scientific and technical literature coming from DOE, its laboratories, energy centers, and contractors. Includes all works deriving from DOE, other related government-sponsored information, and foreign nonnuclear information. Arranged under 39 categories, e.g., Biomedical sciences, basic studies; Biomedical sciences, applied studies; Health and safety; and Fusion energy. Entry gives bibliographical information and abstract. Corporate, author, subject, report number indexes.

Nuclear Safety

Author : Anonim
Publisher : Unknown
Page : 618 pages
File Size : 50,9 Mb
Release : 1986
Category : Nuclear engineering
ISBN : UCAL:B4199960

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Nuclear Safety by Anonim Pdf

Federal Register

Author : Anonim
Publisher : Unknown
Page : 1070 pages
File Size : 46,8 Mb
Release : 1987
Category : Administrative law
ISBN : UIUC:30112058907434

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Federal Register by Anonim Pdf

Annual Report

Author : U.S. Nuclear Regulatory Commission
Publisher : Unknown
Page : 328 pages
File Size : 50,8 Mb
Release : 1996
Category : Nuclear engineering
ISBN : OSU:32435060825130

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Annual Report by U.S. Nuclear Regulatory Commission Pdf

Nuclear Reactor Safety at the Department of Energy's Savannah River Plant

Author : United States. Congress. House. Committee on Government Operations. Environment, Energy, and Natural Resources Subcommittee
Publisher : Unknown
Page : 452 pages
File Size : 44,5 Mb
Release : 1989
Category : Governmental investigations
ISBN : PSU:000014967832

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Nuclear Reactor Safety at the Department of Energy's Savannah River Plant by United States. Congress. House. Committee on Government Operations. Environment, Energy, and Natural Resources Subcommittee Pdf

Probabilistic Safety Assessment and Management

Author : Cornelia Spitzer,Ulrich Schmocker,Vinh N. Dang
Publisher : Springer
Page : 3803 pages
File Size : 49,8 Mb
Release : 2014-01-04
Category : Technology & Engineering
ISBN : 9780857294104

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Probabilistic Safety Assessment and Management by Cornelia Spitzer,Ulrich Schmocker,Vinh N. Dang Pdf

A collection of papers presented at the PSAM 7 – ESREL ’04 conference in June 2004, reflecting a wide variety of disciplines, such as principles and theory of reliability and risk analysis, systems modelling and simulation, consequence assessment, human and organisational factors, structural reliability methods, software reliability and safety, insights and lessons from risk studies and management/decision making. This volume covers both well-established practices and open issues in these fields, identifying areas where maturity has been reached and those where more development is needed.

Integrated Safety Management Process

Author : Geni Bahar,National Cooperative Highway Research Program
Publisher : Transportation Research Board
Page : 156 pages
File Size : 52,7 Mb
Release : 2003
Category : Business & Economics
ISBN : 9780309087704

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Integrated Safety Management Process by Geni Bahar,National Cooperative Highway Research Program Pdf

Rising awareness of and increased attention to sexual harassment has resulted in momentum to implement sexual harassment prevention efforts in higher education institutions. Work on preventing sexual harassment is an area that has recently garnered a lot of attention, especially around education and programs that go beyond the standard anti-sexual harassment trainings often used to comply with legal requirements. On April 20-21, 2021, the National Academies of Sciences, Engineering, and Medicine hosted the workshop Developing Evaluation Metrics for Sexual Harassment Prevention Efforts. The workshop explored approaches and strategies for evaluating and measuring the effectiveness of sexual harassment interventions being implemented at higher education institutions and research and training sites, in order to assist institutions in transforming promising ideas into evidence-based best practices. Workshop participants also addressed methods, metrics, and measures that could be used to evaluate sexual harassment prevention efforts that lead to change in the organizational climate and culture and/or a change in behavior among community members. This publication summarizes the presentations and discussion of the workshop.