Reliable Design of Medical Devices

Forside
CRC Press, 30. jan. 1997 - 728 sider
Presenting the basic concepts and major issues associated with medical device design, this text describes current development processes as well as standards and regulatory information, providing a basis for assessing new technologies. It aims to help manufacturers establish and operate a viable reliability assurance programme, and purchasers to formulate effective methods of vendor evaluation.

Inni boken

 

Utvalgte sider

Innhold

The Medical Device as an Entity
1
12 A Brief History of Medical Devices
4
13 Cuirent Medical Devices
5
The Concept of Failure
9
22 Causes of Failure
11
23 The Practical Aspects of Failures
12
24 Failure Rate
13
25 Hardware Failure
14
153 Trademarks
299
154 Trade Secrets
304
References
309
Human Factors
311
162 The Human Element in Human Factors Engineering
313
16 3 The Hardware Element in Human Factors Engineering
315
165 The Human Factors Process
319
167 Analysis
320

26 Software Failure
16
27 Failure Due to Human Error
17
28 Failure from the Customers Point of View
18
Reliability Assurance
21
33 The Definition of Reliability
23
34 History of Reliability
25
36 Device Reliability
31
37 Optimizing Reliability
33
38 Reliabilitys Effect on Medical Devices
34
References
35
Device Safety
37
41 Definition of Safety
38
42 Safety and Reliability
40
43 The Legal Aspects of Safety
42
44 System Safety
46
45 Hardware Safety
47
46 Software Safety
48
47 Verification and Validation of Safety
50
48 An Effective Safety Program
51
References
54
Device Economics
57
52 Budgeting for Product Development
60
53 Other Economic Parameters
63
54 Life Cycle Costing
67
55 Economics of Warranties
68
References
69
Medical Device Regulations and Standards
71
The Food and Drug Administration
73
62 Device Classification
75
63 Registration and Listing
79
64 The 510k Process
80
65 PMA Application
87
66 Investigation Device Exemptions IDE
90
67 Good Laboratory Practices GLP
93
69 Human Factor s
94
610 Design Control
95
611 The FDA and Software
96
612 Software Classification
98
613 The FDA Inspection
99
614 Advice on Dealing with the FDA
100
References
101
The Medical Device Directives
105
71 Definition of a Medical Device
106
72 The Medical Device Directives Process
107
73 Choosing the Appropriate Directive
108
74 Identifying the Applicable Essential Requirements
109
75 Identification of Corresponding Harmonized Standards
112
76 Assurance that the Device Meets the Essential Requirements and Harmonized Standards
113
77 Classification of the Device
123
78 Decision on the Appropriate Conformity Assessment Procedure
126
79 Type Testing
129
710 Identification and Choice of a Notified Body
130
711 Establishing a Declaration of Conformity
135
712 Application of the CE Mark
136
713 Conclusion
139
ISO 9000 Series of Standards
141
83 Hie ISO 9000 Registration Process
147
84 Choosing a Registrar
152
85 The Certification Audit
153
86 Implementing ISO 9000
158
References
160
Domestic Standards
163
92 Software Standards and Regulations
170
93 Testing Facilities
171
References
173
International Standards
175
102 Hie International Regulate ly Scene
178
103 The TickIT Program
182
104 The Software Quality System Registration Program
183
105 The ISO Guidance Documents for ISO 9001 and 9002
184
106 Proposed Regulatory Requirements for Canada
185
107 ISO 14000 Series
186
108 Medical Informatics
188
References
189
Specifying and Designing the Product
193
Defining the Device
195
111 The Product Definition Process
197
112 Overview of Quality Function Deployment
199
113 The QFD Process
200
114 Summary of QKD
209
115 The Business Proposal
211
References
216
Requirements Engineering
219
122 The Product Specification
224
123 The Reliability Goal
226
124 Specification Review
229
126 The Software Quality Assurance Plan SQAP
231
127 Software Requirements Specification SRS
234
128 The Software Design Description SDD
238
References
240
Risk Management
243
132 Deciding on Acceptable Risk
245
133 Factor s Important to Medical Device Risk Assessment
246
134 Risk Management
250
136 Tools for Risk Estimation
255
References
269
Liability
271
141 Negligence
272
142 Strict Liability
273
143 Breach of Warranty
274
144 Defects
276
145 Failure to Warn of Dangers
278
146 Plaintiffs Conduct
279
149 Manufacturers and Physicians Responsibilities
280
1410 Conclusion
281
Reference
282
Intellectual Property
283
152 Copyrights
293
169 Set Usability Goals
324
1610 Design User Interface Concepts
325
1611 Model he User Interface
327
1612 Test the User Interface
328
1613 Specify the User Interface
329
1614 Additional Human Factors Design Considerations
330
References
351
Establishing and Using Metrics
355
172 Software Complexity Metrics
358
173 Objective and Algorithmic Measurements
359
174 Process and Product Metrics
360
176 Size Metrics
361
177 McCabes Complexity
364
178 Halstead Measures
365
179 Other Software Metrics
368
1710 ComputerAided Metrics
369
References
371
Good Laboratory Practices
373
182 Good Laboratory Practices Regulations
375
183 Good Laboratory Practices Inspections by the FDA
384
184 International Good Laboratory Practices
387
References
390
Hardware Design
391
192 Redundancy
393
193 Component Selection
396
194 Component Derating
401
195 Safety Maigin
402
196 Load Protection
403
197 Environmental Protection
404
199 Initial Reliability Prediction
405
1910 Design for Variation
414
1913 Design Reviews
418
References
420
Software Design
423
202 Design Alternatives and Tradeoffs
425
203 Software Architecture
426
204 Choosing a Methodology
428
205 Stnichired Analysis
429
206 ObjectOriented Design
430
207 Choosing a Language
431
208 Software Risk Analysis
434
209 The Requirements Traceability Matrix
437
2010 Software Review
438
2011 Design Techniques
443
2013 Module Specifications
444
2015 Design Support Tools
445
2016 Design as the Basis for Verification and Validation Activity
446
2017 Conclusion
447
Software Coding
451
213 Good Coding Practices
454
214 Hie Coding Process
456
215 Implementation Checklist
461
References
462
Testing and Data Analysis
463
The Basis and Types of Testing
465
222 Parsing Test Requirements
467
223 Test Protocol
468
225 Purpose of the Test
472
227 Detennining Sample Size and Test Length
473
228 Types of Testing
476
References
486
Hardware Verification and Validation
489
232 Environmental Testing
492
233 Accelerated Testing
499
234 Sudden Death Testing
503
235 The Sudden Death Test
508
References
516
Software Verification and Validation
519
241 Allocation of Software Testing
521
242 Verification and Validation Test Method Commonality
522
243 Validation and Test Overview
524
244 The Essentials of Software Testing
528
References
531
Analysis of Test Results
533
251 Failure Rate
534
252 Mean Time Between Failures MTBF
535
253 Reliability
540
254 Confidence Level
542
255 Confidence Limits
543
256 Minimum Life
545
References
550
The Manufacturing and Maintenance Process
551
GMP and Manufacturing
553
262 The GMP Regulation
556
263 Design for Manufacturability
559
264 Design for Assembly
560
265 The Manufacturing Process
564
References
568
Configuration Management
569
271 Configuration Identification
570
272 Configuration Audits
574
273 Configuration Management Metrics
576
274 FDAs View of Configuration Management
577
27S Status Accounting
578
Analysis of Field Data
581
282 Failure Analysis of Field Units
586
283 Warranty Analysis
587
References
589
Appendices
591
Chi Square Table
593
Appendix 2 Percent Rank Tables
595
Addresses of Standards and Regulatory Agencies
613
Detailed Summary of the Twenty Requirements of ISO 9000
621
Appendix 5 Common Failure Modes
657
Appendix 6 Glossaiy
671
Index
693
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Reliable Design of Medical Devices
Richard C. Fries
Ingen forhåndsvisning tilgjengelig - 1997

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Om forfatteren (1997)

Richard Fries, PE, CSQE, CRE, is president of ISORel, Inc., a consulting firm located in Fitchburg, Wisconsin. He is a licensed professional engineer in the state of Wisconsin and is certified by the American Society for Quality as a Reliability Engineer and a Software Quality Engineer. Mr. Fries is a member of the IEEE Software Engineering Subcommittee. He was a member of the AAMI Medical Device Software Committee that developed IEC 62304. He was also a member of the AAMI Technical Committee that developed ISO 13485.

Bibliografisk informasjon

TittelReliable Design of Medical Devices
ForfatterRichard C. Fries
UtgiverCRC Press, 1997
ISBN1420001019, 9781420001013
Lengde728 sider
  
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