Reliable Design of Medical Devices
Marcel Dekker Inc (Verlag)
978-0-8247-9843-7 (ISBN)
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Fries; Richard Baxter Healthcare, Round Lake, Illinois, USA,
Part 1 Basics of reliability: the medical device as an entity; the concept of failure; reliability versus assurance; device safety; device economics. Part 2 Medical device regulations and standards: the food and drug administration; the medical device directives; ISO 9000 series of standards; domestic standards; international standards. Part 3 Specifying and designing the product: defining the device; requirement engineering; risk management; liability; intellectual property; human factors; establishing and using metrics; good laboratory practices; hardware design; software design; software coding. Part 4 Testing and data analysis: the basis and type of testing; hardware verification and validation; software verification and validation; analysis of test results. Part 5 The manufacturing and maintenance process: configuration management; analysis of field data; appendix 1 - chi-square table; appendix 2 - percent rank tables; appendix 3 - addresses of standards and regulatory agencies; appendix 4 - detailed summary of the requirements of ISO 9000; appendix 5 - common failure modes; appendix 6 - glossary.
| Verlagsort | New York |
|---|---|
| Sprache | englisch |
| Maße | 152 x 229 mm |
| Gewicht | 998 g |
| Themenwelt | Medizin / Pharmazie ► Physiotherapie / Ergotherapie ► Orthopädie |
| Recht / Steuern ► EU / Internationales Recht | |
| Recht / Steuern ► Privatrecht / Bürgerliches Recht ► Medizinrecht | |
| Technik ► Maschinenbau | |
| Technik ► Medizintechnik | |
| ISBN-10 | 0-8247-9843-0 / 0824798430 |
| ISBN-13 | 978-0-8247-9843-7 / 9780824798437 |
| Zustand | Neuware |
| Informationen gemäß Produktsicherheitsverordnung (GPSR) | |
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