Safety Risk Management for Medical Devices
11.3.2 Other considerations for risk reduction end-point11.4 Hazard Identification; 11.5 Clinical Hazards List; 11.6 Harms Assessment List; 11.6.1 How to create a Harms Assessment List; 11.6.1.1 Method 1-Using published data; 11.6.1.2 Method 2-Using expert opinion; 12 Risk Analysis Techniques; 12.1...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Elahi, Bijan [verfasserIn] |
|---|
| Format: |
E-Book |
|---|---|
| Sprache: |
Englisch |
| Erschienen: |
London, United Kingdom: Academic Press, an imprint of Elsevier ; 2018 ©2018 |
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| Schlagwörter: |
Medical instruments and apparatus industry, Risk management BUSINESS & ECONOMICS ; Industries ; General Médecine - Appareils et instruments - Industrie - Gestion du risque |
|---|---|
| Formangabe: |
Electronic books |
| Anmerkung: |
Includes bibliographical references and index |
|---|---|
| Umfang: |
1 Online-Ressource |
| Links: | |
|---|---|
| ISBN: |
0-12-813099-7 978-0-12-813099-5 |
| Katalog-ID: |
1685486703 |
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| 520 | |a 11.3.2 Other considerations for risk reduction end-point11.4 Hazard Identification; 11.5 Clinical Hazards List; 11.6 Harms Assessment List; 11.6.1 How to create a Harms Assessment List; 11.6.1.1 Method 1-Using published data; 11.6.1.2 Method 2-Using expert opinion; 12 Risk Analysis Techniques; 12.1 Fault Tree Analysis; 12.1.1 Introduction; 12.1.2 Theory; 12.1.2.1 Primary, secondary, and command Faults; 12.1.2.2 Immediate, necessary, and sufficient; 12.1.2.3 State of Component-State of System; 12.1.2.4 Common Cause Failures; 12.1.3 Symbols; 12.1.4 Methodology; 12.1.5 Ground rules | ||
| 520 | |a 12.1.5.1 Write faults as faults12.1.5.2 No gate-to-gate connections; 12.1.5.3 Mark low-likelihood faults as Basic Events; 12.1.5.4 Don't model passive components; 12.1.5.5 Be judicious in modeling secondary faults; 12.2 Mind Map Analysis; 12.2.1 Introduction; 12.2.2 Theory; 12.2.3 Methodology; 12.3 Preliminary Hazard Analysis; 12.3.1 Introduction; 12.3.2 Methodology; 12.3.2.1 Safety characteristics; 12.3.2.2 Identify System Hazards; 12.4 Failure Modes and Effects Analysis; 12.4.1 Facilitation of FMEAs; 12.4.2 Hierarchical multilevel FMEA; 12.4.3 Failure theory; 12.4.4 Ground rules | ||
| 520 | |a 3.2 Hazard Theory3.3 System Types; 4 Understanding Risk; 4.1 Risk Definitions; 4.2 Types of Risk; 4.3 Contributors to Risk; 4.4 Risk Perception; 4.5 Risk Computation; 5 Risk Management Standards; 5.1 ISO 14971 History and Origins; 5.2 Harmonized Standards; 6 Requirements of the Risk Management Process; 6.1 Risk Management Process; 6.1.1 Risk analysis; 6.1.1.1 Hazard identification; 6.1.1.2 Risk estimation; 6.1.2 Risk evaluation; 6.1.3 Risk controls; 6.1.4 Risk control verification; 6.1.5 Monitoring; 7 Quality Management System; 8 Usability Engineering and Risk Analysis; 8.1 Key Terms | ||
| 520 | |a 8.2 Distinctions8.3 User-Device Interaction Model; 8.4 Use Failures; 8.5 Environmental Factors; 8.6 Design Means to Control Usability Risks; 8.7 Task Analysis; 8.8 Usability and Risk; 8.8.1 Data gathering; 8.8.2 Risk reduction and compliance with IEC 62366 process; 9 Biocompatibility and Risk Management; 10 The BXM Method; 10.1 System Decomposition; 10.2 Integration; 10.3 Quantitative Risk Estimation; 11 Risk Management Process; 11.1 Management Responsibilities; 11.2 Risk Management File; 11.3 Risk Management Plan; 11.3.1 Criteria for risk acceptability | ||
| 520 | |a Front Cover; Safety Risk Management for Medical Devices; Copyright Page; Dedication; Contents; List of Figures; List of Tables; Biography; Preface; 1 Introduction; 2 Why Do Risk Management?; 2.1 Legal and Regulatory Requirements; 2.1.1 United States; 2.1.2 European Union; 2.1.3 MDD/AIMDD and transition to EU MDR; 2.2 Business Reasons; 2.2.1 Cost efficiency; 2.2.2 Avoiding recalls and field corrective actions; 2.2.3 Better communications; 2.3 Moral and Ethical Reasons; 3 The Basics; 3.1 Vocabulary of Risk Management; 3.1.1 Further elaborations; 3.1.1.1 Reasonably foreseeable misuse | ||
| 520 | |a "Safety Risk Management for Medical Devices demystifies risk management, providing clarity of thought and confidence to the practitioners of risk management as they do their work. Written with practicing engineers, safety management professionals, and students in mind, this book will help readers tackle the difficult questions, such as how to define risk acceptance criteria and how to determine when to stop risk reduction. This book delivers not only theory, but also practical guidance for applying the theory in daily risk management work. The reader is familiarized with the vocabulary of risk management and guided through a process to ensure compliance with the international standard ISO 14971--a requirement for all medical devices. This book outlines sensible, easily comprehensible, and state-of the-art methodologies that are rooted in current industry best practices. Opening chapters introduce the concept of risk, the legal basis for risk management, and the requirements for a compliant risk-management process. The next group of chapters discusses the connection between risk management and quality systems, usability engineering and biocompatibility. This book delves into the techniques of risk management, such as fault tree analysis and failure modes and effects analysis, and continues with risk estimation, risk control, and risk evaluation. Special topics such as software risk management, clinical investigations, and security are also discussed. The latter chapters address benefit-risk analysis, and production and postproduction monitoring. This book concludes with advice and wisdom for sensible, efficient, and successful safety risk management of medical devices.Teaches industry best practices on medical-device risk management in compliance with ISO 14971Provides practical, easy-to-understand, and step-by-step instructions on how to perform hazard analysis and manage the risks of medical devicesOffers a worked-out example applying the risk management process on a hypothetical device"-- | ||
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0128130997 electronic bk. 0-12-813099-7 9780128130995 : electronic bk. 978-0-12-813099-5 (DE-627)1685486703 (DE-576)517998939 (DE-599)KEP026963701 (OCoLC)1043555552 (OCoLC)043555552 (EBP)026963701 (ELSEVIER)on1043555552 DE-627 eng DE-627 rda eng XA-GB HD9994 BUS 070000 bisacsh BUS 070000 bisacsh Elahi, Bijan verfasserin aut Safety Risk Management for Medical Devices Bijan Elahi London, United Kingdom Academic Press, an imprint of Elsevier [2018] ©2018 1 Online-Ressource Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Includes bibliographical references and index 11.3.2 Other considerations for risk reduction end-point11.4 Hazard Identification; 11.5 Clinical Hazards List; 11.6 Harms Assessment List; 11.6.1 How to create a Harms Assessment List; 11.6.1.1 Method 1-Using published data; 11.6.1.2 Method 2-Using expert opinion; 12 Risk Analysis Techniques; 12.1 Fault Tree Analysis; 12.1.1 Introduction; 12.1.2 Theory; 12.1.2.1 Primary, secondary, and command Faults; 12.1.2.2 Immediate, necessary, and sufficient; 12.1.2.3 State of Component-State of System; 12.1.2.4 Common Cause Failures; 12.1.3 Symbols; 12.1.4 Methodology; 12.1.5 Ground rules 12.1.5.1 Write faults as faults12.1.5.2 No gate-to-gate connections; 12.1.5.3 Mark low-likelihood faults as Basic Events; 12.1.5.4 Don't model passive components; 12.1.5.5 Be judicious in modeling secondary faults; 12.2 Mind Map Analysis; 12.2.1 Introduction; 12.2.2 Theory; 12.2.3 Methodology; 12.3 Preliminary Hazard Analysis; 12.3.1 Introduction; 12.3.2 Methodology; 12.3.2.1 Safety characteristics; 12.3.2.2 Identify System Hazards; 12.4 Failure Modes and Effects Analysis; 12.4.1 Facilitation of FMEAs; 12.4.2 Hierarchical multilevel FMEA; 12.4.3 Failure theory; 12.4.4 Ground rules 3.2 Hazard Theory3.3 System Types; 4 Understanding Risk; 4.1 Risk Definitions; 4.2 Types of Risk; 4.3 Contributors to Risk; 4.4 Risk Perception; 4.5 Risk Computation; 5 Risk Management Standards; 5.1 ISO 14971 History and Origins; 5.2 Harmonized Standards; 6 Requirements of the Risk Management Process; 6.1 Risk Management Process; 6.1.1 Risk analysis; 6.1.1.1 Hazard identification; 6.1.1.2 Risk estimation; 6.1.2 Risk evaluation; 6.1.3 Risk controls; 6.1.4 Risk control verification; 6.1.5 Monitoring; 7 Quality Management System; 8 Usability Engineering and Risk Analysis; 8.1 Key Terms 8.2 Distinctions8.3 User-Device Interaction Model; 8.4 Use Failures; 8.5 Environmental Factors; 8.6 Design Means to Control Usability Risks; 8.7 Task Analysis; 8.8 Usability and Risk; 8.8.1 Data gathering; 8.8.2 Risk reduction and compliance with IEC 62366 process; 9 Biocompatibility and Risk Management; 10 The BXM Method; 10.1 System Decomposition; 10.2 Integration; 10.3 Quantitative Risk Estimation; 11 Risk Management Process; 11.1 Management Responsibilities; 11.2 Risk Management File; 11.3 Risk Management Plan; 11.3.1 Criteria for risk acceptability Front Cover; Safety Risk Management for Medical Devices; Copyright Page; Dedication; Contents; List of Figures; List of Tables; Biography; Preface; 1 Introduction; 2 Why Do Risk Management?; 2.1 Legal and Regulatory Requirements; 2.1.1 United States; 2.1.2 European Union; 2.1.3 MDD/AIMDD and transition to EU MDR; 2.2 Business Reasons; 2.2.1 Cost efficiency; 2.2.2 Avoiding recalls and field corrective actions; 2.2.3 Better communications; 2.3 Moral and Ethical Reasons; 3 The Basics; 3.1 Vocabulary of Risk Management; 3.1.1 Further elaborations; 3.1.1.1 Reasonably foreseeable misuse "Safety Risk Management for Medical Devices demystifies risk management, providing clarity of thought and confidence to the practitioners of risk management as they do their work. Written with practicing engineers, safety management professionals, and students in mind, this book will help readers tackle the difficult questions, such as how to define risk acceptance criteria and how to determine when to stop risk reduction. This book delivers not only theory, but also practical guidance for applying the theory in daily risk management work. The reader is familiarized with the vocabulary of risk management and guided through a process to ensure compliance with the international standard ISO 14971--a requirement for all medical devices. This book outlines sensible, easily comprehensible, and state-of the-art methodologies that are rooted in current industry best practices. Opening chapters introduce the concept of risk, the legal basis for risk management, and the requirements for a compliant risk-management process. The next group of chapters discusses the connection between risk management and quality systems, usability engineering and biocompatibility. This book delves into the techniques of risk management, such as fault tree analysis and failure modes and effects analysis, and continues with risk estimation, risk control, and risk evaluation. Special topics such as software risk management, clinical investigations, and security are also discussed. The latter chapters address benefit-risk analysis, and production and postproduction monitoring. This book concludes with advice and wisdom for sensible, efficient, and successful safety risk management of medical devices.Teaches industry best practices on medical-device risk management in compliance with ISO 14971Provides practical, easy-to-understand, and step-by-step instructions on how to perform hazard analysis and manage the risks of medical devicesOffers a worked-out example applying the risk management process on a hypothetical device"-- Medical instruments and apparatus industry Risk management Medical instruments and apparatus industry Risk management BUSINESS & ECONOMICS ; Industries ; General Médecine - Appareils et instruments - Industrie - Gestion du risque (CaQQLa)201-0062215 Electronic books Electronic books 0128130989 9780128130988 Erscheint auch als Druck-Ausgabe 0128130989 9780128130988 https://www.sciencedirect.com/science/book/9780128130988 X:ELSEVIER Verlag lizenzpflichtig Volltext http://www.sciencedirect.com/science/book/9780128130988 Verlag Volltext (DE-627)1028101511 GBV-33-Freedom 2022 BSZ-33-EBS-HSAA GBV-33-EBS-MRI GBV-33-EBS-ZHB GBV-33-Freedom 2021 ZDB-33-EGE 2018 ZDB-33-EBS ZDB-33-ESD GBV-33-EBS-HST BSZ-33-EBS-C1UB GBV_ILN_23 ISIL_DE-830 SYSFLAG_1 GBV_KXP GBV_ILN_105 ISIL_DE-841 GBV_ILN_132 ISIL_DE-959 GBV_ILN_185 ISIL_DE-Sra5 GBV_ILN_370 ISIL_DE-1373 GBV_ILN_2020 ISIL_DE-Ch1 GBV_ILN_2111 ISIL_DE-944 GBV ExPruef BO 045F 338.47681761 23 01 0830 1847612598 ACQ Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots i z 06-02-19 105 01 0841 4074466899 ACQ Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Die Weitergabe an Dritte sowie systematisches Downloaden sind untersagt. z 26-02-22 132 01 0959 4500002065 EBS Elsevier Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots. Zeitlich begrenzte Lizenzierung k 13-03-24 185 01 3519 4514749265 OLR-EBS Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. 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Zugriff von außerhalb nur für HCU-Angehörige möglich https://www.sciencedirect.com/science/book/9780128130988 2020 01 DE-Ch1 https://www.sciencedirect.com/science/book/9780128130988 2111 02 DE-944 https://www.sciencedirect.com/science/book/9780128130988 132 01 0959 00 EBooks Elsevier Engineering 23 01 0830 2018-01865, 2018-01866, 2018-01867, 2018-01868, 2018-01869 105 01 0841 2021 E 121 23 01 0830 ACQ 23 01 0830 olr-else 23 01 0830 olr-else2 105 01 0841 ACQ 105 01 0841 OLR-ELV-ACQ 132 01 0959 EBS Elsevier 185 01 3519 OLR-EBS 370 01 4370 EBS Elsevier |
| spelling |
0128130997 electronic bk. 0-12-813099-7 9780128130995 : electronic bk. 978-0-12-813099-5 (DE-627)1685486703 (DE-576)517998939 (DE-599)KEP026963701 (OCoLC)1043555552 (OCoLC)043555552 (EBP)026963701 (ELSEVIER)on1043555552 DE-627 eng DE-627 rda eng XA-GB HD9994 BUS 070000 bisacsh BUS 070000 bisacsh Elahi, Bijan verfasserin aut Safety Risk Management for Medical Devices Bijan Elahi London, United Kingdom Academic Press, an imprint of Elsevier [2018] ©2018 1 Online-Ressource Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Includes bibliographical references and index 11.3.2 Other considerations for risk reduction end-point11.4 Hazard Identification; 11.5 Clinical Hazards List; 11.6 Harms Assessment List; 11.6.1 How to create a Harms Assessment List; 11.6.1.1 Method 1-Using published data; 11.6.1.2 Method 2-Using expert opinion; 12 Risk Analysis Techniques; 12.1 Fault Tree Analysis; 12.1.1 Introduction; 12.1.2 Theory; 12.1.2.1 Primary, secondary, and command Faults; 12.1.2.2 Immediate, necessary, and sufficient; 12.1.2.3 State of Component-State of System; 12.1.2.4 Common Cause Failures; 12.1.3 Symbols; 12.1.4 Methodology; 12.1.5 Ground rules 12.1.5.1 Write faults as faults12.1.5.2 No gate-to-gate connections; 12.1.5.3 Mark low-likelihood faults as Basic Events; 12.1.5.4 Don't model passive components; 12.1.5.5 Be judicious in modeling secondary faults; 12.2 Mind Map Analysis; 12.2.1 Introduction; 12.2.2 Theory; 12.2.3 Methodology; 12.3 Preliminary Hazard Analysis; 12.3.1 Introduction; 12.3.2 Methodology; 12.3.2.1 Safety characteristics; 12.3.2.2 Identify System Hazards; 12.4 Failure Modes and Effects Analysis; 12.4.1 Facilitation of FMEAs; 12.4.2 Hierarchical multilevel FMEA; 12.4.3 Failure theory; 12.4.4 Ground rules 3.2 Hazard Theory3.3 System Types; 4 Understanding Risk; 4.1 Risk Definitions; 4.2 Types of Risk; 4.3 Contributors to Risk; 4.4 Risk Perception; 4.5 Risk Computation; 5 Risk Management Standards; 5.1 ISO 14971 History and Origins; 5.2 Harmonized Standards; 6 Requirements of the Risk Management Process; 6.1 Risk Management Process; 6.1.1 Risk analysis; 6.1.1.1 Hazard identification; 6.1.1.2 Risk estimation; 6.1.2 Risk evaluation; 6.1.3 Risk controls; 6.1.4 Risk control verification; 6.1.5 Monitoring; 7 Quality Management System; 8 Usability Engineering and Risk Analysis; 8.1 Key Terms 8.2 Distinctions8.3 User-Device Interaction Model; 8.4 Use Failures; 8.5 Environmental Factors; 8.6 Design Means to Control Usability Risks; 8.7 Task Analysis; 8.8 Usability and Risk; 8.8.1 Data gathering; 8.8.2 Risk reduction and compliance with IEC 62366 process; 9 Biocompatibility and Risk Management; 10 The BXM Method; 10.1 System Decomposition; 10.2 Integration; 10.3 Quantitative Risk Estimation; 11 Risk Management Process; 11.1 Management Responsibilities; 11.2 Risk Management File; 11.3 Risk Management Plan; 11.3.1 Criteria for risk acceptability Front Cover; Safety Risk Management for Medical Devices; Copyright Page; Dedication; Contents; List of Figures; List of Tables; Biography; Preface; 1 Introduction; 2 Why Do Risk Management?; 2.1 Legal and Regulatory Requirements; 2.1.1 United States; 2.1.2 European Union; 2.1.3 MDD/AIMDD and transition to EU MDR; 2.2 Business Reasons; 2.2.1 Cost efficiency; 2.2.2 Avoiding recalls and field corrective actions; 2.2.3 Better communications; 2.3 Moral and Ethical Reasons; 3 The Basics; 3.1 Vocabulary of Risk Management; 3.1.1 Further elaborations; 3.1.1.1 Reasonably foreseeable misuse "Safety Risk Management for Medical Devices demystifies risk management, providing clarity of thought and confidence to the practitioners of risk management as they do their work. Written with practicing engineers, safety management professionals, and students in mind, this book will help readers tackle the difficult questions, such as how to define risk acceptance criteria and how to determine when to stop risk reduction. This book delivers not only theory, but also practical guidance for applying the theory in daily risk management work. The reader is familiarized with the vocabulary of risk management and guided through a process to ensure compliance with the international standard ISO 14971--a requirement for all medical devices. This book outlines sensible, easily comprehensible, and state-of the-art methodologies that are rooted in current industry best practices. Opening chapters introduce the concept of risk, the legal basis for risk management, and the requirements for a compliant risk-management process. The next group of chapters discusses the connection between risk management and quality systems, usability engineering and biocompatibility. This book delves into the techniques of risk management, such as fault tree analysis and failure modes and effects analysis, and continues with risk estimation, risk control, and risk evaluation. Special topics such as software risk management, clinical investigations, and security are also discussed. The latter chapters address benefit-risk analysis, and production and postproduction monitoring. This book concludes with advice and wisdom for sensible, efficient, and successful safety risk management of medical devices.Teaches industry best practices on medical-device risk management in compliance with ISO 14971Provides practical, easy-to-understand, and step-by-step instructions on how to perform hazard analysis and manage the risks of medical devicesOffers a worked-out example applying the risk management process on a hypothetical device"-- Medical instruments and apparatus industry Risk management Medical instruments and apparatus industry Risk management BUSINESS & ECONOMICS ; Industries ; General Médecine - Appareils et instruments - Industrie - Gestion du risque (CaQQLa)201-0062215 Electronic books Electronic books 0128130989 9780128130988 Erscheint auch als Druck-Ausgabe 0128130989 9780128130988 https://www.sciencedirect.com/science/book/9780128130988 X:ELSEVIER Verlag lizenzpflichtig Volltext http://www.sciencedirect.com/science/book/9780128130988 Verlag Volltext (DE-627)1028101511 GBV-33-Freedom 2022 BSZ-33-EBS-HSAA GBV-33-EBS-MRI GBV-33-EBS-ZHB GBV-33-Freedom 2021 ZDB-33-EGE 2018 ZDB-33-EBS ZDB-33-ESD GBV-33-EBS-HST BSZ-33-EBS-C1UB GBV_ILN_23 ISIL_DE-830 SYSFLAG_1 GBV_KXP GBV_ILN_105 ISIL_DE-841 GBV_ILN_132 ISIL_DE-959 GBV_ILN_185 ISIL_DE-Sra5 GBV_ILN_370 ISIL_DE-1373 GBV_ILN_2020 ISIL_DE-Ch1 GBV_ILN_2111 ISIL_DE-944 GBV ExPruef BO 045F 338.47681761 23 01 0830 1847612598 ACQ Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots i z 06-02-19 105 01 0841 4074466899 ACQ Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Die Weitergabe an Dritte sowie systematisches Downloaden sind untersagt. z 26-02-22 132 01 0959 4500002065 EBS Elsevier Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots. Zeitlich begrenzte Lizenzierung k 13-03-24 185 01 3519 4514749265 OLR-EBS Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Die Weitergabe an Dritte sowie systematisches Downloaden sind untersagt. z 23-04-24 370 01 4370 4540279793 EBS Elsevier Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots. i z 20-06-24 2020 01 DE-Ch1 4520355184 00 --%%-- --%%-- n n Campuslizenz l01 03-05-24 2111 02 DE-944 4046041048 00 --%%-- E-Book Elsevier --%%-- n Elektronischer Volltext - Campuslizenz l01 27-01-22 23 01 0830 Elsevier EBook https://www.sciencedirect.com/science/book/9780128130988 105 01 0841 http://www.sciencedirect.com/science/book/9780128130988 132 01 0959 Zugriff nur für Angehörige der Hochschule Osnabrück im Hochschulnetz https://www.sciencedirect.com/science/book/9780128130988 185 01 3519 http://www.sciencedirect.com/science/book/9780128130988 370 01 4370 E-Book: Zugriff im HCU-Netz. Zugriff von außerhalb nur für HCU-Angehörige möglich https://www.sciencedirect.com/science/book/9780128130988 2020 01 DE-Ch1 https://www.sciencedirect.com/science/book/9780128130988 2111 02 DE-944 https://www.sciencedirect.com/science/book/9780128130988 132 01 0959 00 EBooks Elsevier Engineering 23 01 0830 2018-01865, 2018-01866, 2018-01867, 2018-01868, 2018-01869 105 01 0841 2021 E 121 23 01 0830 ACQ 23 01 0830 olr-else 23 01 0830 olr-else2 105 01 0841 ACQ 105 01 0841 OLR-ELV-ACQ 132 01 0959 EBS Elsevier 185 01 3519 OLR-EBS 370 01 4370 EBS Elsevier |
| allfields_unstemmed |
0128130997 electronic bk. 0-12-813099-7 9780128130995 : electronic bk. 978-0-12-813099-5 (DE-627)1685486703 (DE-576)517998939 (DE-599)KEP026963701 (OCoLC)1043555552 (OCoLC)043555552 (EBP)026963701 (ELSEVIER)on1043555552 DE-627 eng DE-627 rda eng XA-GB HD9994 BUS 070000 bisacsh BUS 070000 bisacsh Elahi, Bijan verfasserin aut Safety Risk Management for Medical Devices Bijan Elahi London, United Kingdom Academic Press, an imprint of Elsevier [2018] ©2018 1 Online-Ressource Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Includes bibliographical references and index 11.3.2 Other considerations for risk reduction end-point11.4 Hazard Identification; 11.5 Clinical Hazards List; 11.6 Harms Assessment List; 11.6.1 How to create a Harms Assessment List; 11.6.1.1 Method 1-Using published data; 11.6.1.2 Method 2-Using expert opinion; 12 Risk Analysis Techniques; 12.1 Fault Tree Analysis; 12.1.1 Introduction; 12.1.2 Theory; 12.1.2.1 Primary, secondary, and command Faults; 12.1.2.2 Immediate, necessary, and sufficient; 12.1.2.3 State of Component-State of System; 12.1.2.4 Common Cause Failures; 12.1.3 Symbols; 12.1.4 Methodology; 12.1.5 Ground rules 12.1.5.1 Write faults as faults12.1.5.2 No gate-to-gate connections; 12.1.5.3 Mark low-likelihood faults as Basic Events; 12.1.5.4 Don't model passive components; 12.1.5.5 Be judicious in modeling secondary faults; 12.2 Mind Map Analysis; 12.2.1 Introduction; 12.2.2 Theory; 12.2.3 Methodology; 12.3 Preliminary Hazard Analysis; 12.3.1 Introduction; 12.3.2 Methodology; 12.3.2.1 Safety characteristics; 12.3.2.2 Identify System Hazards; 12.4 Failure Modes and Effects Analysis; 12.4.1 Facilitation of FMEAs; 12.4.2 Hierarchical multilevel FMEA; 12.4.3 Failure theory; 12.4.4 Ground rules 3.2 Hazard Theory3.3 System Types; 4 Understanding Risk; 4.1 Risk Definitions; 4.2 Types of Risk; 4.3 Contributors to Risk; 4.4 Risk Perception; 4.5 Risk Computation; 5 Risk Management Standards; 5.1 ISO 14971 History and Origins; 5.2 Harmonized Standards; 6 Requirements of the Risk Management Process; 6.1 Risk Management Process; 6.1.1 Risk analysis; 6.1.1.1 Hazard identification; 6.1.1.2 Risk estimation; 6.1.2 Risk evaluation; 6.1.3 Risk controls; 6.1.4 Risk control verification; 6.1.5 Monitoring; 7 Quality Management System; 8 Usability Engineering and Risk Analysis; 8.1 Key Terms 8.2 Distinctions8.3 User-Device Interaction Model; 8.4 Use Failures; 8.5 Environmental Factors; 8.6 Design Means to Control Usability Risks; 8.7 Task Analysis; 8.8 Usability and Risk; 8.8.1 Data gathering; 8.8.2 Risk reduction and compliance with IEC 62366 process; 9 Biocompatibility and Risk Management; 10 The BXM Method; 10.1 System Decomposition; 10.2 Integration; 10.3 Quantitative Risk Estimation; 11 Risk Management Process; 11.1 Management Responsibilities; 11.2 Risk Management File; 11.3 Risk Management Plan; 11.3.1 Criteria for risk acceptability Front Cover; Safety Risk Management for Medical Devices; Copyright Page; Dedication; Contents; List of Figures; List of Tables; Biography; Preface; 1 Introduction; 2 Why Do Risk Management?; 2.1 Legal and Regulatory Requirements; 2.1.1 United States; 2.1.2 European Union; 2.1.3 MDD/AIMDD and transition to EU MDR; 2.2 Business Reasons; 2.2.1 Cost efficiency; 2.2.2 Avoiding recalls and field corrective actions; 2.2.3 Better communications; 2.3 Moral and Ethical Reasons; 3 The Basics; 3.1 Vocabulary of Risk Management; 3.1.1 Further elaborations; 3.1.1.1 Reasonably foreseeable misuse "Safety Risk Management for Medical Devices demystifies risk management, providing clarity of thought and confidence to the practitioners of risk management as they do their work. Written with practicing engineers, safety management professionals, and students in mind, this book will help readers tackle the difficult questions, such as how to define risk acceptance criteria and how to determine when to stop risk reduction. This book delivers not only theory, but also practical guidance for applying the theory in daily risk management work. The reader is familiarized with the vocabulary of risk management and guided through a process to ensure compliance with the international standard ISO 14971--a requirement for all medical devices. This book outlines sensible, easily comprehensible, and state-of the-art methodologies that are rooted in current industry best practices. Opening chapters introduce the concept of risk, the legal basis for risk management, and the requirements for a compliant risk-management process. The next group of chapters discusses the connection between risk management and quality systems, usability engineering and biocompatibility. This book delves into the techniques of risk management, such as fault tree analysis and failure modes and effects analysis, and continues with risk estimation, risk control, and risk evaluation. Special topics such as software risk management, clinical investigations, and security are also discussed. The latter chapters address benefit-risk analysis, and production and postproduction monitoring. This book concludes with advice and wisdom for sensible, efficient, and successful safety risk management of medical devices.Teaches industry best practices on medical-device risk management in compliance with ISO 14971Provides practical, easy-to-understand, and step-by-step instructions on how to perform hazard analysis and manage the risks of medical devicesOffers a worked-out example applying the risk management process on a hypothetical device"-- Medical instruments and apparatus industry Risk management Medical instruments and apparatus industry Risk management BUSINESS & ECONOMICS ; Industries ; General Médecine - Appareils et instruments - Industrie - Gestion du risque (CaQQLa)201-0062215 Electronic books Electronic books 0128130989 9780128130988 Erscheint auch als Druck-Ausgabe 0128130989 9780128130988 https://www.sciencedirect.com/science/book/9780128130988 X:ELSEVIER Verlag lizenzpflichtig Volltext http://www.sciencedirect.com/science/book/9780128130988 Verlag Volltext (DE-627)1028101511 GBV-33-Freedom 2022 BSZ-33-EBS-HSAA GBV-33-EBS-MRI GBV-33-EBS-ZHB GBV-33-Freedom 2021 ZDB-33-EGE 2018 ZDB-33-EBS ZDB-33-ESD GBV-33-EBS-HST BSZ-33-EBS-C1UB GBV_ILN_23 ISIL_DE-830 SYSFLAG_1 GBV_KXP GBV_ILN_105 ISIL_DE-841 GBV_ILN_132 ISIL_DE-959 GBV_ILN_185 ISIL_DE-Sra5 GBV_ILN_370 ISIL_DE-1373 GBV_ILN_2020 ISIL_DE-Ch1 GBV_ILN_2111 ISIL_DE-944 GBV ExPruef BO 045F 338.47681761 23 01 0830 1847612598 ACQ Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots i z 06-02-19 105 01 0841 4074466899 ACQ Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Die Weitergabe an Dritte sowie systematisches Downloaden sind untersagt. z 26-02-22 132 01 0959 4500002065 EBS Elsevier Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots. Zeitlich begrenzte Lizenzierung k 13-03-24 185 01 3519 4514749265 OLR-EBS Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Die Weitergabe an Dritte sowie systematisches Downloaden sind untersagt. z 23-04-24 370 01 4370 4540279793 EBS Elsevier Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots. i z 20-06-24 2020 01 DE-Ch1 4520355184 00 --%%-- --%%-- n n Campuslizenz l01 03-05-24 2111 02 DE-944 4046041048 00 --%%-- E-Book Elsevier --%%-- n Elektronischer Volltext - Campuslizenz l01 27-01-22 23 01 0830 Elsevier EBook https://www.sciencedirect.com/science/book/9780128130988 105 01 0841 http://www.sciencedirect.com/science/book/9780128130988 132 01 0959 Zugriff nur für Angehörige der Hochschule Osnabrück im Hochschulnetz https://www.sciencedirect.com/science/book/9780128130988 185 01 3519 http://www.sciencedirect.com/science/book/9780128130988 370 01 4370 E-Book: Zugriff im HCU-Netz. Zugriff von außerhalb nur für HCU-Angehörige möglich https://www.sciencedirect.com/science/book/9780128130988 2020 01 DE-Ch1 https://www.sciencedirect.com/science/book/9780128130988 2111 02 DE-944 https://www.sciencedirect.com/science/book/9780128130988 132 01 0959 00 EBooks Elsevier Engineering 23 01 0830 2018-01865, 2018-01866, 2018-01867, 2018-01868, 2018-01869 105 01 0841 2021 E 121 23 01 0830 ACQ 23 01 0830 olr-else 23 01 0830 olr-else2 105 01 0841 ACQ 105 01 0841 OLR-ELV-ACQ 132 01 0959 EBS Elsevier 185 01 3519 OLR-EBS 370 01 4370 EBS Elsevier |
| allfieldsGer |
0128130997 electronic bk. 0-12-813099-7 9780128130995 : electronic bk. 978-0-12-813099-5 (DE-627)1685486703 (DE-576)517998939 (DE-599)KEP026963701 (OCoLC)1043555552 (OCoLC)043555552 (EBP)026963701 (ELSEVIER)on1043555552 DE-627 eng DE-627 rda eng XA-GB HD9994 BUS 070000 bisacsh BUS 070000 bisacsh Elahi, Bijan verfasserin aut Safety Risk Management for Medical Devices Bijan Elahi London, United Kingdom Academic Press, an imprint of Elsevier [2018] ©2018 1 Online-Ressource Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Includes bibliographical references and index 11.3.2 Other considerations for risk reduction end-point11.4 Hazard Identification; 11.5 Clinical Hazards List; 11.6 Harms Assessment List; 11.6.1 How to create a Harms Assessment List; 11.6.1.1 Method 1-Using published data; 11.6.1.2 Method 2-Using expert opinion; 12 Risk Analysis Techniques; 12.1 Fault Tree Analysis; 12.1.1 Introduction; 12.1.2 Theory; 12.1.2.1 Primary, secondary, and command Faults; 12.1.2.2 Immediate, necessary, and sufficient; 12.1.2.3 State of Component-State of System; 12.1.2.4 Common Cause Failures; 12.1.3 Symbols; 12.1.4 Methodology; 12.1.5 Ground rules 12.1.5.1 Write faults as faults12.1.5.2 No gate-to-gate connections; 12.1.5.3 Mark low-likelihood faults as Basic Events; 12.1.5.4 Don't model passive components; 12.1.5.5 Be judicious in modeling secondary faults; 12.2 Mind Map Analysis; 12.2.1 Introduction; 12.2.2 Theory; 12.2.3 Methodology; 12.3 Preliminary Hazard Analysis; 12.3.1 Introduction; 12.3.2 Methodology; 12.3.2.1 Safety characteristics; 12.3.2.2 Identify System Hazards; 12.4 Failure Modes and Effects Analysis; 12.4.1 Facilitation of FMEAs; 12.4.2 Hierarchical multilevel FMEA; 12.4.3 Failure theory; 12.4.4 Ground rules 3.2 Hazard Theory3.3 System Types; 4 Understanding Risk; 4.1 Risk Definitions; 4.2 Types of Risk; 4.3 Contributors to Risk; 4.4 Risk Perception; 4.5 Risk Computation; 5 Risk Management Standards; 5.1 ISO 14971 History and Origins; 5.2 Harmonized Standards; 6 Requirements of the Risk Management Process; 6.1 Risk Management Process; 6.1.1 Risk analysis; 6.1.1.1 Hazard identification; 6.1.1.2 Risk estimation; 6.1.2 Risk evaluation; 6.1.3 Risk controls; 6.1.4 Risk control verification; 6.1.5 Monitoring; 7 Quality Management System; 8 Usability Engineering and Risk Analysis; 8.1 Key Terms 8.2 Distinctions8.3 User-Device Interaction Model; 8.4 Use Failures; 8.5 Environmental Factors; 8.6 Design Means to Control Usability Risks; 8.7 Task Analysis; 8.8 Usability and Risk; 8.8.1 Data gathering; 8.8.2 Risk reduction and compliance with IEC 62366 process; 9 Biocompatibility and Risk Management; 10 The BXM Method; 10.1 System Decomposition; 10.2 Integration; 10.3 Quantitative Risk Estimation; 11 Risk Management Process; 11.1 Management Responsibilities; 11.2 Risk Management File; 11.3 Risk Management Plan; 11.3.1 Criteria for risk acceptability Front Cover; Safety Risk Management for Medical Devices; Copyright Page; Dedication; Contents; List of Figures; List of Tables; Biography; Preface; 1 Introduction; 2 Why Do Risk Management?; 2.1 Legal and Regulatory Requirements; 2.1.1 United States; 2.1.2 European Union; 2.1.3 MDD/AIMDD and transition to EU MDR; 2.2 Business Reasons; 2.2.1 Cost efficiency; 2.2.2 Avoiding recalls and field corrective actions; 2.2.3 Better communications; 2.3 Moral and Ethical Reasons; 3 The Basics; 3.1 Vocabulary of Risk Management; 3.1.1 Further elaborations; 3.1.1.1 Reasonably foreseeable misuse "Safety Risk Management for Medical Devices demystifies risk management, providing clarity of thought and confidence to the practitioners of risk management as they do their work. Written with practicing engineers, safety management professionals, and students in mind, this book will help readers tackle the difficult questions, such as how to define risk acceptance criteria and how to determine when to stop risk reduction. This book delivers not only theory, but also practical guidance for applying the theory in daily risk management work. The reader is familiarized with the vocabulary of risk management and guided through a process to ensure compliance with the international standard ISO 14971--a requirement for all medical devices. This book outlines sensible, easily comprehensible, and state-of the-art methodologies that are rooted in current industry best practices. Opening chapters introduce the concept of risk, the legal basis for risk management, and the requirements for a compliant risk-management process. The next group of chapters discusses the connection between risk management and quality systems, usability engineering and biocompatibility. This book delves into the techniques of risk management, such as fault tree analysis and failure modes and effects analysis, and continues with risk estimation, risk control, and risk evaluation. Special topics such as software risk management, clinical investigations, and security are also discussed. The latter chapters address benefit-risk analysis, and production and postproduction monitoring. This book concludes with advice and wisdom for sensible, efficient, and successful safety risk management of medical devices.Teaches industry best practices on medical-device risk management in compliance with ISO 14971Provides practical, easy-to-understand, and step-by-step instructions on how to perform hazard analysis and manage the risks of medical devicesOffers a worked-out example applying the risk management process on a hypothetical device"-- Medical instruments and apparatus industry Risk management Medical instruments and apparatus industry Risk management BUSINESS & ECONOMICS ; Industries ; General Médecine - Appareils et instruments - Industrie - Gestion du risque (CaQQLa)201-0062215 Electronic books Electronic books 0128130989 9780128130988 Erscheint auch als Druck-Ausgabe 0128130989 9780128130988 https://www.sciencedirect.com/science/book/9780128130988 X:ELSEVIER Verlag lizenzpflichtig Volltext http://www.sciencedirect.com/science/book/9780128130988 Verlag Volltext (DE-627)1028101511 GBV-33-Freedom 2022 BSZ-33-EBS-HSAA GBV-33-EBS-MRI GBV-33-EBS-ZHB GBV-33-Freedom 2021 ZDB-33-EGE 2018 ZDB-33-EBS ZDB-33-ESD GBV-33-EBS-HST BSZ-33-EBS-C1UB GBV_ILN_23 ISIL_DE-830 SYSFLAG_1 GBV_KXP GBV_ILN_105 ISIL_DE-841 GBV_ILN_132 ISIL_DE-959 GBV_ILN_185 ISIL_DE-Sra5 GBV_ILN_370 ISIL_DE-1373 GBV_ILN_2020 ISIL_DE-Ch1 GBV_ILN_2111 ISIL_DE-944 GBV ExPruef BO 045F 338.47681761 23 01 0830 1847612598 ACQ Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots i z 06-02-19 105 01 0841 4074466899 ACQ Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Die Weitergabe an Dritte sowie systematisches Downloaden sind untersagt. z 26-02-22 132 01 0959 4500002065 EBS Elsevier Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots. Zeitlich begrenzte Lizenzierung k 13-03-24 185 01 3519 4514749265 OLR-EBS Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Die Weitergabe an Dritte sowie systematisches Downloaden sind untersagt. z 23-04-24 370 01 4370 4540279793 EBS Elsevier Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots. i z 20-06-24 2020 01 DE-Ch1 4520355184 00 --%%-- --%%-- n n Campuslizenz l01 03-05-24 2111 02 DE-944 4046041048 00 --%%-- E-Book Elsevier --%%-- n Elektronischer Volltext - Campuslizenz l01 27-01-22 23 01 0830 Elsevier EBook https://www.sciencedirect.com/science/book/9780128130988 105 01 0841 http://www.sciencedirect.com/science/book/9780128130988 132 01 0959 Zugriff nur für Angehörige der Hochschule Osnabrück im Hochschulnetz https://www.sciencedirect.com/science/book/9780128130988 185 01 3519 http://www.sciencedirect.com/science/book/9780128130988 370 01 4370 E-Book: Zugriff im HCU-Netz. Zugriff von außerhalb nur für HCU-Angehörige möglich https://www.sciencedirect.com/science/book/9780128130988 2020 01 DE-Ch1 https://www.sciencedirect.com/science/book/9780128130988 2111 02 DE-944 https://www.sciencedirect.com/science/book/9780128130988 132 01 0959 00 EBooks Elsevier Engineering 23 01 0830 2018-01865, 2018-01866, 2018-01867, 2018-01868, 2018-01869 105 01 0841 2021 E 121 23 01 0830 ACQ 23 01 0830 olr-else 23 01 0830 olr-else2 105 01 0841 ACQ 105 01 0841 OLR-ELV-ACQ 132 01 0959 EBS Elsevier 185 01 3519 OLR-EBS 370 01 4370 EBS Elsevier |
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0128130997 electronic bk. 0-12-813099-7 9780128130995 : electronic bk. 978-0-12-813099-5 (DE-627)1685486703 (DE-576)517998939 (DE-599)KEP026963701 (OCoLC)1043555552 (OCoLC)043555552 (EBP)026963701 (ELSEVIER)on1043555552 DE-627 eng DE-627 rda eng XA-GB HD9994 BUS 070000 bisacsh BUS 070000 bisacsh Elahi, Bijan verfasserin aut Safety Risk Management for Medical Devices Bijan Elahi London, United Kingdom Academic Press, an imprint of Elsevier [2018] ©2018 1 Online-Ressource Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Includes bibliographical references and index 11.3.2 Other considerations for risk reduction end-point11.4 Hazard Identification; 11.5 Clinical Hazards List; 11.6 Harms Assessment List; 11.6.1 How to create a Harms Assessment List; 11.6.1.1 Method 1-Using published data; 11.6.1.2 Method 2-Using expert opinion; 12 Risk Analysis Techniques; 12.1 Fault Tree Analysis; 12.1.1 Introduction; 12.1.2 Theory; 12.1.2.1 Primary, secondary, and command Faults; 12.1.2.2 Immediate, necessary, and sufficient; 12.1.2.3 State of Component-State of System; 12.1.2.4 Common Cause Failures; 12.1.3 Symbols; 12.1.4 Methodology; 12.1.5 Ground rules 12.1.5.1 Write faults as faults12.1.5.2 No gate-to-gate connections; 12.1.5.3 Mark low-likelihood faults as Basic Events; 12.1.5.4 Don't model passive components; 12.1.5.5 Be judicious in modeling secondary faults; 12.2 Mind Map Analysis; 12.2.1 Introduction; 12.2.2 Theory; 12.2.3 Methodology; 12.3 Preliminary Hazard Analysis; 12.3.1 Introduction; 12.3.2 Methodology; 12.3.2.1 Safety characteristics; 12.3.2.2 Identify System Hazards; 12.4 Failure Modes and Effects Analysis; 12.4.1 Facilitation of FMEAs; 12.4.2 Hierarchical multilevel FMEA; 12.4.3 Failure theory; 12.4.4 Ground rules 3.2 Hazard Theory3.3 System Types; 4 Understanding Risk; 4.1 Risk Definitions; 4.2 Types of Risk; 4.3 Contributors to Risk; 4.4 Risk Perception; 4.5 Risk Computation; 5 Risk Management Standards; 5.1 ISO 14971 History and Origins; 5.2 Harmonized Standards; 6 Requirements of the Risk Management Process; 6.1 Risk Management Process; 6.1.1 Risk analysis; 6.1.1.1 Hazard identification; 6.1.1.2 Risk estimation; 6.1.2 Risk evaluation; 6.1.3 Risk controls; 6.1.4 Risk control verification; 6.1.5 Monitoring; 7 Quality Management System; 8 Usability Engineering and Risk Analysis; 8.1 Key Terms 8.2 Distinctions8.3 User-Device Interaction Model; 8.4 Use Failures; 8.5 Environmental Factors; 8.6 Design Means to Control Usability Risks; 8.7 Task Analysis; 8.8 Usability and Risk; 8.8.1 Data gathering; 8.8.2 Risk reduction and compliance with IEC 62366 process; 9 Biocompatibility and Risk Management; 10 The BXM Method; 10.1 System Decomposition; 10.2 Integration; 10.3 Quantitative Risk Estimation; 11 Risk Management Process; 11.1 Management Responsibilities; 11.2 Risk Management File; 11.3 Risk Management Plan; 11.3.1 Criteria for risk acceptability Front Cover; Safety Risk Management for Medical Devices; Copyright Page; Dedication; Contents; List of Figures; List of Tables; Biography; Preface; 1 Introduction; 2 Why Do Risk Management?; 2.1 Legal and Regulatory Requirements; 2.1.1 United States; 2.1.2 European Union; 2.1.3 MDD/AIMDD and transition to EU MDR; 2.2 Business Reasons; 2.2.1 Cost efficiency; 2.2.2 Avoiding recalls and field corrective actions; 2.2.3 Better communications; 2.3 Moral and Ethical Reasons; 3 The Basics; 3.1 Vocabulary of Risk Management; 3.1.1 Further elaborations; 3.1.1.1 Reasonably foreseeable misuse "Safety Risk Management for Medical Devices demystifies risk management, providing clarity of thought and confidence to the practitioners of risk management as they do their work. Written with practicing engineers, safety management professionals, and students in mind, this book will help readers tackle the difficult questions, such as how to define risk acceptance criteria and how to determine when to stop risk reduction. This book delivers not only theory, but also practical guidance for applying the theory in daily risk management work. The reader is familiarized with the vocabulary of risk management and guided through a process to ensure compliance with the international standard ISO 14971--a requirement for all medical devices. This book outlines sensible, easily comprehensible, and state-of the-art methodologies that are rooted in current industry best practices. Opening chapters introduce the concept of risk, the legal basis for risk management, and the requirements for a compliant risk-management process. The next group of chapters discusses the connection between risk management and quality systems, usability engineering and biocompatibility. This book delves into the techniques of risk management, such as fault tree analysis and failure modes and effects analysis, and continues with risk estimation, risk control, and risk evaluation. Special topics such as software risk management, clinical investigations, and security are also discussed. The latter chapters address benefit-risk analysis, and production and postproduction monitoring. This book concludes with advice and wisdom for sensible, efficient, and successful safety risk management of medical devices.Teaches industry best practices on medical-device risk management in compliance with ISO 14971Provides practical, easy-to-understand, and step-by-step instructions on how to perform hazard analysis and manage the risks of medical devicesOffers a worked-out example applying the risk management process on a hypothetical device"-- Medical instruments and apparatus industry Risk management Medical instruments and apparatus industry Risk management BUSINESS & ECONOMICS ; Industries ; General Médecine - Appareils et instruments - Industrie - Gestion du risque (CaQQLa)201-0062215 Electronic books Electronic books 0128130989 9780128130988 Erscheint auch als Druck-Ausgabe 0128130989 9780128130988 https://www.sciencedirect.com/science/book/9780128130988 X:ELSEVIER Verlag lizenzpflichtig Volltext http://www.sciencedirect.com/science/book/9780128130988 Verlag Volltext (DE-627)1028101511 GBV-33-Freedom 2022 BSZ-33-EBS-HSAA GBV-33-EBS-MRI GBV-33-EBS-ZHB GBV-33-Freedom 2021 ZDB-33-EGE 2018 ZDB-33-EBS ZDB-33-ESD GBV-33-EBS-HST BSZ-33-EBS-C1UB GBV_ILN_23 ISIL_DE-830 SYSFLAG_1 GBV_KXP GBV_ILN_105 ISIL_DE-841 GBV_ILN_132 ISIL_DE-959 GBV_ILN_185 ISIL_DE-Sra5 GBV_ILN_370 ISIL_DE-1373 GBV_ILN_2020 ISIL_DE-Ch1 GBV_ILN_2111 ISIL_DE-944 GBV ExPruef BO 045F 338.47681761 23 01 0830 1847612598 ACQ Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots i z 06-02-19 105 01 0841 4074466899 ACQ Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Die Weitergabe an Dritte sowie systematisches Downloaden sind untersagt. z 26-02-22 132 01 0959 4500002065 EBS Elsevier Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots. Zeitlich begrenzte Lizenzierung k 13-03-24 185 01 3519 4514749265 OLR-EBS Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Die Weitergabe an Dritte sowie systematisches Downloaden sind untersagt. z 23-04-24 370 01 4370 4540279793 EBS Elsevier Vervielfältigungen (z.B. Kopien, Downloads) sind nur von einzelnen Kapiteln oder Seiten und nur zum eigenen wissenschaftlichen Gebrauch erlaubt. Keine Weitergabe an Dritte. Kein systematisches Downloaden durch Robots. i z 20-06-24 2020 01 DE-Ch1 4520355184 00 --%%-- --%%-- n n Campuslizenz l01 03-05-24 2111 02 DE-944 4046041048 00 --%%-- E-Book Elsevier --%%-- n Elektronischer Volltext - Campuslizenz l01 27-01-22 23 01 0830 Elsevier EBook https://www.sciencedirect.com/science/book/9780128130988 105 01 0841 http://www.sciencedirect.com/science/book/9780128130988 132 01 0959 Zugriff nur für Angehörige der Hochschule Osnabrück im Hochschulnetz https://www.sciencedirect.com/science/book/9780128130988 185 01 3519 http://www.sciencedirect.com/science/book/9780128130988 370 01 4370 E-Book: Zugriff im HCU-Netz. 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11.3.2 Other considerations for risk reduction end-point11.4 Hazard Identification; 11.5 Clinical Hazards List; 11.6 Harms Assessment List; 11.6.1 How to create a Harms Assessment List; 11.6.1.1 Method 1-Using published data; 11.6.1.2 Method 2-Using expert opinion; 12 Risk Analysis Techniques; 12.1 Fault Tree Analysis; 12.1.1 Introduction; 12.1.2 Theory; 12.1.2.1 Primary, secondary, and command Faults; 12.1.2.2 Immediate, necessary, and sufficient; 12.1.2.3 State of Component-State of System; 12.1.2.4 Common Cause Failures; 12.1.3 Symbols; 12.1.4 Methodology; 12.1.5 Ground rules 12.1.5.1 Write faults as faults12.1.5.2 No gate-to-gate connections; 12.1.5.3 Mark low-likelihood faults as Basic Events; 12.1.5.4 Don't model passive components; 12.1.5.5 Be judicious in modeling secondary faults; 12.2 Mind Map Analysis; 12.2.1 Introduction; 12.2.2 Theory; 12.2.3 Methodology; 12.3 Preliminary Hazard Analysis; 12.3.1 Introduction; 12.3.2 Methodology; 12.3.2.1 Safety characteristics; 12.3.2.2 Identify System Hazards; 12.4 Failure Modes and Effects Analysis; 12.4.1 Facilitation of FMEAs; 12.4.2 Hierarchical multilevel FMEA; 12.4.3 Failure theory; 12.4.4 Ground rules 3.2 Hazard Theory3.3 System Types; 4 Understanding Risk; 4.1 Risk Definitions; 4.2 Types of Risk; 4.3 Contributors to Risk; 4.4 Risk Perception; 4.5 Risk Computation; 5 Risk Management Standards; 5.1 ISO 14971 History and Origins; 5.2 Harmonized Standards; 6 Requirements of the Risk Management Process; 6.1 Risk Management Process; 6.1.1 Risk analysis; 6.1.1.1 Hazard identification; 6.1.1.2 Risk estimation; 6.1.2 Risk evaluation; 6.1.3 Risk controls; 6.1.4 Risk control verification; 6.1.5 Monitoring; 7 Quality Management System; 8 Usability Engineering and Risk Analysis; 8.1 Key Terms 8.2 Distinctions8.3 User-Device Interaction Model; 8.4 Use Failures; 8.5 Environmental Factors; 8.6 Design Means to Control Usability Risks; 8.7 Task Analysis; 8.8 Usability and Risk; 8.8.1 Data gathering; 8.8.2 Risk reduction and compliance with IEC 62366 process; 9 Biocompatibility and Risk Management; 10 The BXM Method; 10.1 System Decomposition; 10.2 Integration; 10.3 Quantitative Risk Estimation; 11 Risk Management Process; 11.1 Management Responsibilities; 11.2 Risk Management File; 11.3 Risk Management Plan; 11.3.1 Criteria for risk acceptability Front Cover; Safety Risk Management for Medical Devices; Copyright Page; Dedication; Contents; List of Figures; List of Tables; Biography; Preface; 1 Introduction; 2 Why Do Risk Management?; 2.1 Legal and Regulatory Requirements; 2.1.1 United States; 2.1.2 European Union; 2.1.3 MDD/AIMDD and transition to EU MDR; 2.2 Business Reasons; 2.2.1 Cost efficiency; 2.2.2 Avoiding recalls and field corrective actions; 2.2.3 Better communications; 2.3 Moral and Ethical Reasons; 3 The Basics; 3.1 Vocabulary of Risk Management; 3.1.1 Further elaborations; 3.1.1.1 Reasonably foreseeable misuse "Safety Risk Management for Medical Devices demystifies risk management, providing clarity of thought and confidence to the practitioners of risk management as they do their work. Written with practicing engineers, safety management professionals, and students in mind, this book will help readers tackle the difficult questions, such as how to define risk acceptance criteria and how to determine when to stop risk reduction. This book delivers not only theory, but also practical guidance for applying the theory in daily risk management work. The reader is familiarized with the vocabulary of risk management and guided through a process to ensure compliance with the international standard ISO 14971--a requirement for all medical devices. This book outlines sensible, easily comprehensible, and state-of the-art methodologies that are rooted in current industry best practices. Opening chapters introduce the concept of risk, the legal basis for risk management, and the requirements for a compliant risk-management process. The next group of chapters discusses the connection between risk management and quality systems, usability engineering and biocompatibility. This book delves into the techniques of risk management, such as fault tree analysis and failure modes and effects analysis, and continues with risk estimation, risk control, and risk evaluation. Special topics such as software risk management, clinical investigations, and security are also discussed. The latter chapters address benefit-risk analysis, and production and postproduction monitoring. This book concludes with advice and wisdom for sensible, efficient, and successful safety risk management of medical devices.Teaches industry best practices on medical-device risk management in compliance with ISO 14971Provides practical, easy-to-understand, and step-by-step instructions on how to perform hazard analysis and manage the risks of medical devicesOffers a worked-out example applying the risk management process on a hypothetical device"-- Includes bibliographical references and index |
| abstractGer |
11.3.2 Other considerations for risk reduction end-point11.4 Hazard Identification; 11.5 Clinical Hazards List; 11.6 Harms Assessment List; 11.6.1 How to create a Harms Assessment List; 11.6.1.1 Method 1-Using published data; 11.6.1.2 Method 2-Using expert opinion; 12 Risk Analysis Techniques; 12.1 Fault Tree Analysis; 12.1.1 Introduction; 12.1.2 Theory; 12.1.2.1 Primary, secondary, and command Faults; 12.1.2.2 Immediate, necessary, and sufficient; 12.1.2.3 State of Component-State of System; 12.1.2.4 Common Cause Failures; 12.1.3 Symbols; 12.1.4 Methodology; 12.1.5 Ground rules 12.1.5.1 Write faults as faults12.1.5.2 No gate-to-gate connections; 12.1.5.3 Mark low-likelihood faults as Basic Events; 12.1.5.4 Don't model passive components; 12.1.5.5 Be judicious in modeling secondary faults; 12.2 Mind Map Analysis; 12.2.1 Introduction; 12.2.2 Theory; 12.2.3 Methodology; 12.3 Preliminary Hazard Analysis; 12.3.1 Introduction; 12.3.2 Methodology; 12.3.2.1 Safety characteristics; 12.3.2.2 Identify System Hazards; 12.4 Failure Modes and Effects Analysis; 12.4.1 Facilitation of FMEAs; 12.4.2 Hierarchical multilevel FMEA; 12.4.3 Failure theory; 12.4.4 Ground rules 3.2 Hazard Theory3.3 System Types; 4 Understanding Risk; 4.1 Risk Definitions; 4.2 Types of Risk; 4.3 Contributors to Risk; 4.4 Risk Perception; 4.5 Risk Computation; 5 Risk Management Standards; 5.1 ISO 14971 History and Origins; 5.2 Harmonized Standards; 6 Requirements of the Risk Management Process; 6.1 Risk Management Process; 6.1.1 Risk analysis; 6.1.1.1 Hazard identification; 6.1.1.2 Risk estimation; 6.1.2 Risk evaluation; 6.1.3 Risk controls; 6.1.4 Risk control verification; 6.1.5 Monitoring; 7 Quality Management System; 8 Usability Engineering and Risk Analysis; 8.1 Key Terms 8.2 Distinctions8.3 User-Device Interaction Model; 8.4 Use Failures; 8.5 Environmental Factors; 8.6 Design Means to Control Usability Risks; 8.7 Task Analysis; 8.8 Usability and Risk; 8.8.1 Data gathering; 8.8.2 Risk reduction and compliance with IEC 62366 process; 9 Biocompatibility and Risk Management; 10 The BXM Method; 10.1 System Decomposition; 10.2 Integration; 10.3 Quantitative Risk Estimation; 11 Risk Management Process; 11.1 Management Responsibilities; 11.2 Risk Management File; 11.3 Risk Management Plan; 11.3.1 Criteria for risk acceptability Front Cover; Safety Risk Management for Medical Devices; Copyright Page; Dedication; Contents; List of Figures; List of Tables; Biography; Preface; 1 Introduction; 2 Why Do Risk Management?; 2.1 Legal and Regulatory Requirements; 2.1.1 United States; 2.1.2 European Union; 2.1.3 MDD/AIMDD and transition to EU MDR; 2.2 Business Reasons; 2.2.1 Cost efficiency; 2.2.2 Avoiding recalls and field corrective actions; 2.2.3 Better communications; 2.3 Moral and Ethical Reasons; 3 The Basics; 3.1 Vocabulary of Risk Management; 3.1.1 Further elaborations; 3.1.1.1 Reasonably foreseeable misuse "Safety Risk Management for Medical Devices demystifies risk management, providing clarity of thought and confidence to the practitioners of risk management as they do their work. Written with practicing engineers, safety management professionals, and students in mind, this book will help readers tackle the difficult questions, such as how to define risk acceptance criteria and how to determine when to stop risk reduction. This book delivers not only theory, but also practical guidance for applying the theory in daily risk management work. The reader is familiarized with the vocabulary of risk management and guided through a process to ensure compliance with the international standard ISO 14971--a requirement for all medical devices. This book outlines sensible, easily comprehensible, and state-of the-art methodologies that are rooted in current industry best practices. Opening chapters introduce the concept of risk, the legal basis for risk management, and the requirements for a compliant risk-management process. The next group of chapters discusses the connection between risk management and quality systems, usability engineering and biocompatibility. This book delves into the techniques of risk management, such as fault tree analysis and failure modes and effects analysis, and continues with risk estimation, risk control, and risk evaluation. Special topics such as software risk management, clinical investigations, and security are also discussed. The latter chapters address benefit-risk analysis, and production and postproduction monitoring. This book concludes with advice and wisdom for sensible, efficient, and successful safety risk management of medical devices.Teaches industry best practices on medical-device risk management in compliance with ISO 14971Provides practical, easy-to-understand, and step-by-step instructions on how to perform hazard analysis and manage the risks of medical devicesOffers a worked-out example applying the risk management process on a hypothetical device"-- Includes bibliographical references and index |
| abstract_unstemmed |
11.3.2 Other considerations for risk reduction end-point11.4 Hazard Identification; 11.5 Clinical Hazards List; 11.6 Harms Assessment List; 11.6.1 How to create a Harms Assessment List; 11.6.1.1 Method 1-Using published data; 11.6.1.2 Method 2-Using expert opinion; 12 Risk Analysis Techniques; 12.1 Fault Tree Analysis; 12.1.1 Introduction; 12.1.2 Theory; 12.1.2.1 Primary, secondary, and command Faults; 12.1.2.2 Immediate, necessary, and sufficient; 12.1.2.3 State of Component-State of System; 12.1.2.4 Common Cause Failures; 12.1.3 Symbols; 12.1.4 Methodology; 12.1.5 Ground rules 12.1.5.1 Write faults as faults12.1.5.2 No gate-to-gate connections; 12.1.5.3 Mark low-likelihood faults as Basic Events; 12.1.5.4 Don't model passive components; 12.1.5.5 Be judicious in modeling secondary faults; 12.2 Mind Map Analysis; 12.2.1 Introduction; 12.2.2 Theory; 12.2.3 Methodology; 12.3 Preliminary Hazard Analysis; 12.3.1 Introduction; 12.3.2 Methodology; 12.3.2.1 Safety characteristics; 12.3.2.2 Identify System Hazards; 12.4 Failure Modes and Effects Analysis; 12.4.1 Facilitation of FMEAs; 12.4.2 Hierarchical multilevel FMEA; 12.4.3 Failure theory; 12.4.4 Ground rules 3.2 Hazard Theory3.3 System Types; 4 Understanding Risk; 4.1 Risk Definitions; 4.2 Types of Risk; 4.3 Contributors to Risk; 4.4 Risk Perception; 4.5 Risk Computation; 5 Risk Management Standards; 5.1 ISO 14971 History and Origins; 5.2 Harmonized Standards; 6 Requirements of the Risk Management Process; 6.1 Risk Management Process; 6.1.1 Risk analysis; 6.1.1.1 Hazard identification; 6.1.1.2 Risk estimation; 6.1.2 Risk evaluation; 6.1.3 Risk controls; 6.1.4 Risk control verification; 6.1.5 Monitoring; 7 Quality Management System; 8 Usability Engineering and Risk Analysis; 8.1 Key Terms 8.2 Distinctions8.3 User-Device Interaction Model; 8.4 Use Failures; 8.5 Environmental Factors; 8.6 Design Means to Control Usability Risks; 8.7 Task Analysis; 8.8 Usability and Risk; 8.8.1 Data gathering; 8.8.2 Risk reduction and compliance with IEC 62366 process; 9 Biocompatibility and Risk Management; 10 The BXM Method; 10.1 System Decomposition; 10.2 Integration; 10.3 Quantitative Risk Estimation; 11 Risk Management Process; 11.1 Management Responsibilities; 11.2 Risk Management File; 11.3 Risk Management Plan; 11.3.1 Criteria for risk acceptability Front Cover; Safety Risk Management for Medical Devices; Copyright Page; Dedication; Contents; List of Figures; List of Tables; Biography; Preface; 1 Introduction; 2 Why Do Risk Management?; 2.1 Legal and Regulatory Requirements; 2.1.1 United States; 2.1.2 European Union; 2.1.3 MDD/AIMDD and transition to EU MDR; 2.2 Business Reasons; 2.2.1 Cost efficiency; 2.2.2 Avoiding recalls and field corrective actions; 2.2.3 Better communications; 2.3 Moral and Ethical Reasons; 3 The Basics; 3.1 Vocabulary of Risk Management; 3.1.1 Further elaborations; 3.1.1.1 Reasonably foreseeable misuse "Safety Risk Management for Medical Devices demystifies risk management, providing clarity of thought and confidence to the practitioners of risk management as they do their work. Written with practicing engineers, safety management professionals, and students in mind, this book will help readers tackle the difficult questions, such as how to define risk acceptance criteria and how to determine when to stop risk reduction. This book delivers not only theory, but also practical guidance for applying the theory in daily risk management work. The reader is familiarized with the vocabulary of risk management and guided through a process to ensure compliance with the international standard ISO 14971--a requirement for all medical devices. This book outlines sensible, easily comprehensible, and state-of the-art methodologies that are rooted in current industry best practices. Opening chapters introduce the concept of risk, the legal basis for risk management, and the requirements for a compliant risk-management process. The next group of chapters discusses the connection between risk management and quality systems, usability engineering and biocompatibility. This book delves into the techniques of risk management, such as fault tree analysis and failure modes and effects analysis, and continues with risk estimation, risk control, and risk evaluation. Special topics such as software risk management, clinical investigations, and security are also discussed. The latter chapters address benefit-risk analysis, and production and postproduction monitoring. This book concludes with advice and wisdom for sensible, efficient, and successful safety risk management of medical devices.Teaches industry best practices on medical-device risk management in compliance with ISO 14971Provides practical, easy-to-understand, and step-by-step instructions on how to perform hazard analysis and manage the risks of medical devicesOffers a worked-out example applying the risk management process on a hypothetical device"-- Includes bibliographical references and index |
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