Integrated Safety Assessment Report PDF Download
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Author | : Shayne C. Gad |
Publisher | : Springer Nature |
Total Pages | : 490 |
Release | : 2020-02-24 |
Genre | : Medical |
ISBN | : 3030352412 |
Download Integrated Safety and Risk Assessment for Medical Devices and Combination Products Book in PDF, ePub and Kindle
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.
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Release | : 1987 |
Genre | : Nuclear power plants |
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Download Integrated Safety Assessment Report Book in PDF, ePub and Kindle
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Release | : 1987 |
Genre | : Nuclear power plants |
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Download Integrated Safety Assessment Report, Integrated Safety Assessment Program Book in PDF, ePub and Kindle
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Total Pages | : 25 |
Release | : 2001 |
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Download Preliminary Integrated Safety Analysis Status Report Book in PDF, ePub and Kindle
This report provides the status of the potential Monitored Geologic Repository (MGR) Integrated Safety Analysis (EA) by identifying the initial work scope scheduled for completion during the ISA development period, the schedules associated with the tasks identified, safety analysis issues encountered, and a summary of accomplishments during the reporting period. This status covers the period from October 1, 2000 through March 30, 2001.
Author | : Cornelia Spitzer |
Publisher | : Springer |
Total Pages | : 3803 |
Release | : 2014-01-04 |
Genre | : Technology & Engineering |
ISBN | : 0857294105 |
Download Probabilistic Safety Assessment and Management Book in PDF, ePub and Kindle
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.
Author | : Duane Kritzinger |
Publisher | : Woodhead Publishing |
Total Pages | : 424 |
Release | : 2016-09-12 |
Genre | : Business & Economics |
ISBN | : 0081009321 |
Download Aircraft System Safety Book in PDF, ePub and Kindle
Aircraft System Safety: Assessments for Initial Airworthiness Certification presents a practical guide for the novice safety practitioner in the more specific area of assessing aircraft system failures to show compliance to regulations such as FAR25.1302 and 1309. A case study and safety strategy beginning in chapter two shows the reader how to bring safety assessment together in a logical and efficient manner. Written to supplement (not replace) the content of the advisory material to these regulations (e.g. AMC25.1309) as well as the main supporting reference standards (e.g. SAE ARP 4761, RTCA/DO-178, RTCA/DO-154), this book strives to amalgamate all these different documents into a consolidated strategy with simple process maps to aid in their understanding and optimise their efficient use. Covers the effect of design, manufacturing, and maintenance errors and the effects of common component errors Evaluates the malfunctioning of multiple aircraft components and the interaction which various aircraft systems have on the ability of the aircraft to continue safe flight and landing Presents and defines a case study (an aircraft modification program) and a safety strategy in the second chapter, after which each of the following chapters will explore the theory of the technique required and then apply the theory to the case study
Author | : Sue Cox |
Publisher | : Routledge |
Total Pages | : 344 |
Release | : 1998 |
Genre | : Business & Economics |
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Download Safety, Reliability and Risk Management Book in PDF, ePub and Kindle
On systems reliability
Author | : Duane Kritzinger |
Publisher | : Woodhead Publishing |
Total Pages | : 367 |
Release | : 2006-06-30 |
Genre | : Technology & Engineering |
ISBN | : 1845691504 |
Download Aircraft System Safety Book in PDF, ePub and Kindle
Demonstrating safety for the application of ever more complex technologies is a formidable task. System engineers often do not have the appropriate training, are unfamiliar with the range of safety approaches, tools and techniques, and their managers do not know when and how these may be applied and appropriately resourced. Aircraft system safety provides a basic skill set for designers, safety practitioners, and their managers by exploring the relationship between safety, legal liability and regulatory requirements. Different approaches to measuring safety are discussed, along with the appropriate safety criteria used in judging acceptability.A wealth of ideas, examples, concepts, tools and approaches from diverse sources and industries is used in Aircraft system safety to bring the theory of safety concisely together in a practical and comprehensive reference. Engineering students, designers, safety assessors (and their managers), regulatory authorities (especially military), customers and projects teams should find Aircraft system safety provides an invaluable guide in appreciating the context, value and limitations of the various safety approaches used in cost-effectively accomplishing safety objectives. Explores the practical aspects of safety Invaluable guide for students, designers, and safety assessors Written by a leading expert in the field
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Release | : 1988 |
Genre | : Nuclear power plants |
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Download Integrated Safety Assessment Program II (ISAP II) Book in PDF, ePub and Kindle
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Release | : 2020 |
Genre | : |
ISBN | : 9781944888244 |
Download Approaches for Integrating Information from Radiation Biology and Epidemiology to Enhance Low-dose Health Risk Assessment Book in PDF, ePub and Kindle
"This Report extends the concepts and approaches discussed in NCRP Report No. 171 and Commentary No. 24 to further reduce uncertainty in radiation risk assessments at low doses and low dose rates, thereby enhancing the bases for radiation protection guidance"--