Reliable design of medical devices:
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| Main Author: | |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
Boca Raton [u.a.]
CRC/Taylor & Francis
2006
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| Edition: | 2. ed. |
| Subjects: | |
| Online Access: | Publisher description Inhaltsverzeichnis |
| Item Description: | Includes bibliographical references and index |
| Physical Description: | XXVI, 475 S. graph. Darst. 25 cm |
| ISBN: | 0824723759 |
Staff View
MARC
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| 020 | |a 0824723759 |c hardcover : alk. paper |9 0-8247-2375-9 | ||
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| 082 | 0 | |a 681/.761 | |
| 100 | 1 | |a Fries, Richard C. |e Verfasser |4 aut | |
| 245 | 1 | 0 | |a Reliable design of medical devices |c Richard Fries |
| 250 | |a 2. ed. | ||
| 264 | 1 | |a Boca Raton [u.a.] |b CRC/Taylor & Francis |c 2006 | |
| 300 | |a XXVI, 475 S. |b graph. Darst. |c 25 cm | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 500 | |a Includes bibliographical references and index | ||
| 650 | 4 | |a Médecine - Appareils et instruments - Conception et construction | |
| 650 | 4 | |a Médecine - Appareils et instruments - Fiabilité | |
| 650 | 4 | |a Médecine - Appareils et instruments - Normes | |
| 650 | 4 | |a Médecine - Appareils et instruments - Qualité - Contrôle | |
| 650 | 4 | |a Medical instruments and apparatus |x Reliability | |
| 650 | 4 | |a Medical instruments and apparatus |x Design and construction | |
| 650 | 4 | |a Medical instruments and apparatus |x Quality control | |
| 650 | 4 | |a Medical instruments and apparatus |x Standards | |
| 856 | 4 | |u http://www.loc.gov/catdir/enhancements/fy0648/2005043942-d.html |3 Publisher description | |
| 856 | 4 | 2 | |m HBZ Datenaustausch |q application/pdf |u http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=014874899&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |3 Inhaltsverzeichnis |
| 999 | |a oai:aleph.bib-bvb.de:BVB01-014874899 | ||
Record in the Search Index
| _version_ | 1804135471268233216 |
|---|---|
| adam_text | Table of Contents
Preface v
Section 1
Basics of reliability. 1
Chapter 1 Reliability 3
1.1 History of reliability 3
1.2 The definition of reliability 4
1.3 Quality versus reliability 5
1.4 Reliability versus unreliability 6
1.5 Types of reliability 7
1.5.1 Electronic reliability 7
1.5.1.1 Infant mortality 7
1.5.1.2 Useful life 8
1.5.1.3 Wearout 8
1.5.2 Mechanical reliability 8
1.5.3 Software reliability 9
1.5.4 Device reliability 10
1.6 Optimizing reliability 12
1.7 Reliability assurance 12
1.8 Reliability s effect on medical devices 12
References 13
Chapter 2 The concept of failure 15
2.1 Failure 15
2.2 Causes of failure 16
2.3 The practical aspects of failures 17
2.4 Failure rate 18
2.5 Hardware failures 18
2.5.1 Early failures 19
2.5.2 Chance failures 19
2.5.3 Wearout failures 19
2.6 Software failures 20
2.7 Failures due to human error 21
2.8 Failures from the customer s point of view 21
References 22
xi
A . Contents
5.4 Quality system 81
5.5 Design controls 81
5.6 Document controls 83
5.7 Purchasing controls 84
5.8 Identification and traceability 85
5.9 Production and process controls 85
5.10 Acceptance activities 88
5.11 Non conforming product 89
5.12 Corrective and preventive action 89
5.13 Labeling and packaging controls 90
5.14 Handling, storage, distribution, and installation 91
5.15 Records 92
5.16 Servicing requirements 93
References 94
Chapter 6 Domestic standards 95
6.1 Domestic standards organizations 95
6.1.1 AAMI 95
6.1.2 ANSI 96
6.1.3 ASQC 96
6.1.4 ASTM 96
6.1.5 IEEE 96
6.1.6 IES 96
6.1.7 IPC 97
6.1.8 NEMA 97
6.1.9 NFPA 97
6.1.10 OSHA 97
6.1.11 UL 97
6.2 Software standards and regulations 98
References 99
Chapter 7 International standards 101
7.1 The international notion of standards 102
7.2 The international regulatory scene 103
7.2.1 BSI 103
7.2.2 CEN 103
7.2.3 CENELAC 103
7.2.4 CISPR 104
7.2.5 CSA 104
7.2.6 DIN 104
7.2.7 DoH 104
7.2.8 IEC 105
7.2.9 IEE 105
7.2.10 ISO 105
7.2.11 JSA 105
contents xv
7.2.12 Other Japanese standards organizations 105
7.3 The TickIT program 106
7.4 The Software Quality System Registration program 106
7.5 The ISO guidance documents for ISO 9001 and 9002 107
7.6 Proposed regulatory requirements for Canada 108
7.7 ISO 14000 series 108
7.8 Medical informatics 110
References Ill
Section 3
Specifying the product 113
Chapter 8 The medical device as an entity 115
8.1 What is a medical device? 115
8.1.1 Food and Drug Administration 116
8.1.2 The Medical Device Directives 116
8.2 A brief history of medical devices 117
8.3 Current medical devices 117
References 119
Chapter 9 Defining the device 121
9.1 The product definition process 122
9.1.1 Surveying the customer 123
9.1.2 Defining the company s needs 123
9.1.3 What are the company s competencies? 123
9.1.4 What are the outside competencies? 124
9.1.5 Completing the product definition 124
9.2 Overview of quality function deployment 124
9.3 The QFD process 125
9.3.1 The voice of the customer 125
9.3.2 The technical portion of the matrix 126
9.3.3 Overview of the QFD process 127
9.4 Summary of QFD 131
9.5 The business proposal 133
9.5.1 Project overview, objectives, major milestones,
and schedule 134
9.5.2 Market need and market potential 134
9.5.3 Product proposal 135
9.5.4 Strategic fit 135
9.5.5 Risk analysis and research plan 135
9.5.6 Economic analysis 137
9.5.7 Core project team 137
References 138
xvj Contents
Chapter 10 Requirements engineering 139
10.1 Requirements, design, verification, and validation 140
10.1.1 Refinement of requirements 141
10.1.2 Assimilation of requirements 141
10.1.3 Requirements versus design 143
10.2 The product specification 144
10.3 The reliability goal 145
10.4 Specification review 147
10.5 The design specification 147
10.6 The software quality assurance plan (SQAP) 148
10.6.1 Purpose 149
10.6.2 Reference documents 149
10.6.3 Management 149
10.6.4 Documentation 149
10.6.5 Standards, practices, conventions, and metrics 149
10.6.6 Review and audits 150
10.6.7 Test 150
10.6.8 Problem reporting and corrective action 150
10.6.9 Tools, techniques, and methodologies 150
10.6.10 Code control 150
10.6.11 Media control 150
10.6.12 Supplier control 150
10.6.13 Records collection, maintenance, and retention 151
10.6.14 Training 151
10.6.15 Risk management 151
10.6.16 Additional sections as required 151
10.7 Software requirements specification (SRS) 151
10.7.1 Purpose 151
10.7.2 Scope 152
10.7.3 Definitions, acronyms, and abbreviations 152
10.7.4 References 152
10.7.5 Overview 152
10.7.6 Product perspective 152
10.7.7 Product functions 152
10.7.8 User characteristics 152
10.7.9 General constraints 153
10.7.10 Assumptions and dependencies 153
10.7.11 Specific requirements 153
10.8 The software design description (SDD) 153
10.8.1 Decomposition description 154
10.8.2 Dependency description 154
10.8.3 Interface description 155
10.8.4 Detailed design description 155
References 155
Contents xvii
Chapter 11 Safety and risk management 157
11.1 Risk 158
11.2 Deciding on acceptable risk 160
11.3 Factors important to medical device risk assessment 160
11.3.1 Device design and manufacture 160
11.3.2 Materials 161
11.3.3 Device users 161
11.3.4 Human factors 162
11.3.5 Medical device systems 162
11.4 Risk management 162
11.5 The risk management process 162
11.5.1 Identifying the risk factors 164
11.5.2 Assessing risk probabilities and effects on
the project 164
11.5.3 Developing strategies to mitigate identified risks 165
11.5.4 Monitoring risk factors 165
11.5.5 Invoking a contingency plan 166
11.5.6 Managing the crisis 166
11.5.7 Recovering from the crisis 166
11.6 Tools for risk estimation 166
11.6.1 Hazard/risk analysis 166
11.6.2 Failure mode and effects analysis 169
11.6.2.1 The FMEA process 169
11.6.3 Fault tree analysis 172
11.6.3.1 The fault tree process 172
11.6.3.2 Example of a fault tree analysis 173
References 176
Chapter 12 Liability 177
12.1 Negligence 178
12.2 Strict liability 179
12.3 Breach of warranty 179
12.3.1 Implied warranties 179
12.3.2 Exclusion of warranties 180
12.4 Defects 180
12.5 Failure to warn of dangers 182
12.6 Plaintiff s conduct 182
12.7 Defendant s conduct 183
12.8 Defendant related issues 183
12.9 Manufacturer s and physician s responsibilities 183
12.10 Conclusion 184
References 185
contents
Chapter 13 Intellectual property 187
13.1 Patents 188
13.1.1 What qualifies as a patent 188
13.1.1.1 Patentable subject matter 189
13.1.1.2 Usefulness 189
13.1.1.3 Novelty 189
13.1.1.4 Non obviousness 189
13.1.1.5 Improvement of an existing invention 190
13.1.1.6 A design 190
13.1.2 The patent process 191
13.1.3 Patent claims 192
13.1.4 Protecting your rights as an inventor 192
13.1.5 Patent infringement 193
13.2 Copyrights 194
13.2.1 What can be copyrighted? 195
13.2.2 The copyright process 196
13.2.2.1 Copyright notice 196
13.2.2.2 Copyright registration 197
13.2.3 Copyright duration 197
13.2.4 Protecting your copyright rights 198
13.2.5 Infringement 198
13.3 Trademarks 198
13.3.1 Selecting a trademark 199
13.3.1.1 What is a distinctive trademark? 200
13.3.2 The trademark process 201
13.3.3 Intent to use registration 201
13.3.4 Protecting your trademark rights 202
13.4 Trade secrets 202
13.4.1 What qualifies for trade secrecy 203
13.4.2 Trade secrecy authorship 203
13.4.3 How trade secrets are lost 203
13.4.4 Duration of trade secrets 204
13.4.5 Protecting your trade secret rights 204
13.4.6 A trade secrecy program 204
13.4.7 Use of trade secrecy with copyrights and patents 205
13.4.7.1 Trade secrets and patents 205
13.4.7.2 Trade secrets and copyrights 205
References k 205
Section 4
Designing the product 207
Chapter 14 Six Sigma and product design 209
14.1 Design for Six Sigma 210
14.2 Methodologies 210
Contents xix
14.3 Structure 212
14.4 Design for Six Sigma tools 213
14.4.1 Robust design 213
14.4.1.1 Why use the robust design methodology? 213
14.4.1.2 Typical problems addressed by
robust design 214
14.4.1.3 Robustness strategy 214
14.4.1.3.1 P diagram 216
14.4.1.4 Quality measurement 216
14.4.1.5 Signal to noise (S/N) ratios 216
14.4.1.5.1 Static vs. dynamic
S/N ratios 217
14.4.1.5.2 Steps in robust parameter
design 217
14.4.2 Quality function deployment 218
14.4.3 Robust design failure mode and effects analysis 218
14.4.3.1 Benefits of a robust DFMEA 219
14.4.3.2 The parameter diagram 219
14.4.3.3 Performing a robust DFMEA 221
14.4.3.4 Conclusion 225
14.4.4 Axiomatic design 226
14.4.4.1 What is axiomatic design? 226
14.4.4.2 Mapping of axiomatic design 227
References 229
Chapter 15 Hardware design 231
15.1 Block diagram 232
15.2 Redundancy 232
15.2.1 Active redundancy 233
15.2.2 Standby redundancy 234
15.3 Component selection 235
15.3.1 Component fitness for use 236
15.3.2 Component reliability 236
15.3.3 Component history 237
15.3.4 Component safety 238
15.4 Component derating 238
15.5 Safety margin 239
15.6 Load protection 240
15.7 Environmental protection 240
15.8 Product misuse 240
15.9 Initial reliability prediction 241
15.9.1 Parts count prediction 242
15.9.2 Parts count prediction example 244
15.9.3 Summary of reliability prediction 248
15.10 Design for variation 248
xx|) Contents i
19.8 Conduct user studies 308 I
19.8.1 Observations 308 |
19.8.2 Interviews 308
19.8.3 Focus groups 309
19.8.4 Task analysis 309
19.8.5 Benchmark usability test 310
19.8.6 Write user profile 310
19.8.7 Set up an advisory panel 310
19.9 Set usability goals 310
19.10 Design user interface concepts 311
19.10.1 Develop conceptual model 311
19.10.2 Develop user interface structure 311
19.10.3 Define interaction style 312
19.10.4 Develop screen templates 312
19.10.5 Develop hardware layout 312
19.10.6 Develop a screenplay 312
19.10.7 Develop a refined design 312
19.10.8 Develop a final design 312
19.11 Model the user interface 313
19.12 Test the user interface 313
19.13 Specify the user interface 314
19.13.1 Style guide 314
19.13.2 Screen hierarchy map 314
19.13.3 Screenplay 314
19.13.4 Specification prototype 314
19.13.5 Hardware layouts 315
19.14 Additional human factors design considerations 315
19.14.1 Consistency and simplicity 315
19.14.2 Safety 315
19.14.3 Environmental/organizational considerations 316
19.14.4 Documentation 316
19.14.5 Anthropometry 317
19.14.6 Functional dimensions 317
19.14.7 Psychological elements 319
19.14.8 Workstation design considerations 320
19.14.9 Alarms and signals 320
19.14.10 Labeling 323
19.14.11 Software 324
19.14.12 Data entry 325
19.14.13 Displays 325
19.14.14 Interactive control 327
19.14.15 Feedback .. .. . . . . . . . . . . . . . . 328
19.14.16 Prompts 328
19.14.17 Defaults 329
19.14.18 Error management/data protection 329
References i?q
Contents xxiii
Section 5
Testing and data analysis 331
Chapter 20 The basis and types of testing 333
20.1 Testing defined 334
20.2 Parsing test requirements 335
20.3 Test protocol 337
20.4 Test methodology 337
20.4.1 Time testing 337
20.4.2 Event testing 337
20.4.3 Stress testing 337
20.4.4 Environmental testing 338
20.4.5 Time related 338
20.4.6 Failure related 339
20.5 Purpose of the test 339
20.6 Failure definition 339
20.7 Determining sample size and test length 339
20.7.1 Example 20 1 340
20.7.2 Example 20 2 341
20.8 Types of testing 342
20.8.1 Verification 342
20.8.2 Validation 342
20.8.3 Black box 342
20.8.4 White box 343
20.8.5 Hardware testing 343
20.8.6 Software testing 343
20.8.7 Functional testing 344
20.8.8 Robustness testing 345
20.8.9 Stress testing 345
20.8.10 Safety testing 346
20.8.11 Regression testing 347
References 348
Chapter 21 Hardware verification and validation 349
21.1 Standard tests 350
21.1.1 Cycle testing ..., 350
21.1.2 Typical use testing 350
21.1.3 10 x 10 testing 350
21.2 Environmental testing 351
21.2.1 Operating temperature testing 352
21.2.2 Storage temperature testing 352
21.2.3 Thermal shock testing 352
21.2.4 Humidity testing 353
21.2.5 Mechanical shock testing 353
a*i» Contents j
21.2.6 Mechanical vibration testing 354 j
21.2.7 Impact testing 354
21.2.8 Electrostatic discharge 355
21.2.9 Electromagnetic compatibility 355
21.3 Accelerated testing 356
21.3.1 Increasing sample size 356
21.3.2 Increasing test severity 356
21.3.3 Example 21 1 357
21.3.4 Example 21 2 358
21.4 Sudden death testing 359
21.4.1 Weibull testing and plotting 359
21.4.1.1 Example 21 3 359
21.4.1.2 Confidence limits 360
21.4.1.3 The shape of Weibull plots 361
21.5 The sudden death test 362
21.5.1 Sudden death example 365
References 369
Chapter 22 Software verification and validation 371
22.1 Allocation of software testing 373
22.2 Verification and validation test method commonality 373
22.3 Validation and test overview 375
22.3.1 Techniques, methodologies, and test approach 375
22.3.2 Software testing requirements 377
22.3.3 Verification and validation reporting 378
22.4 The essentials of software testing 378
22.4.1 The quality of the test process determines the success
of the test effort 379
22.4.2 Prevent defect migration by using early life cycle
testing techniques 379
22.4.3 The time for software testing tools is now 379
22.4.4 A real person must take responsibility for improving
the testing process 380
22.4.5 Testing is a professional discipline requiring trained
and skilled people 380
22.4.6 Cultivate a positive team attitude of creative
destruction 380
References 381
Chapter 23 Analysis of test results 383
23.1 Failure rate 384
23.1.1 Example 23 1 384
23.1.2 Example 23 2 ........! 384
23.2 Mean time between failures (MTBF). 385
23.2.1 Time terminated, failed parts replaced 385
Contents xxv
23.2.1.1 Example 23 3 385
23.2.2 Time terminated, no replacement 386
23.2.3 Failure terminated, failed parts replaced 387
23.2.3.1 Example 23 4 387
23.2.4 Failure terminated, no replacement 387
23.2.5 No failures observed 388
23.2.5.1 Example 23 5 388
23.3 Reliability 388
23.3.1 Example 23 6 389
23.3.2 Example 23 7 389
23.4 Confidence level 390
23.4.1 Example 23 8 390
23.5 Confidence limits 390
23.5.1 Time terminated confidence limits 390
23.5.1.1 Example 23 9 391
23.5.2 Failure terminated confidence limits 391
23.6 Minimum life 392
23.7 Graphical analysis 392
23.7.1 Pareto analysis 392
23.7.2 Graphical plotting 393
23.7.2.1 Example 23 10 393
23.7.3 Weibull plotting 394
References 394
Section 6
The manufacturing and maintenance processes ... 395
Chapter 24 GMPs and manufacturing 397
24.1 A history of GMPs 398
24.2 The GMP regulation 400
24.2.1 Design controls 400
24.2.2 Purchasing controls 400
24.2.3 Servicing controls 401
24.2.4 Changes in critical device requirements 401
24.2.5 Harmonization 401
24.3 Design for manufacturability 402
24.3.1 The DFM process 402
24.4 Design for assembly 403
24.4.1 Overall design concept 403
24.4.2 Component mounting 403
24.4.3 Test points 403
24.4.4 Stress levels and tolerances 404
24.4.5 PCBs 404
24.4.6 Miscellaneous 404
xxvi Contents j
|
24.4.7 Design for assembly process 404 j
24.5 The manufacturing process 405 ;
24.5.1 Pre production activity 405
24.5.2 The pilot run build 406 ;
24.5.3 The production run 407
24.5.4 Customer delivery 407
References 407
Chapter 25 Configuration management 409
25.1 Configuration identification 410
25.1.1 Functional baseline 410
25.1.2 Allocated baseline 411
25.1.3 Developmental configuration 412
25.1.4 Product baseline 412
25.2 Configuration audits 412
25.2.1 Functional configuration audits 413
25.2.2 Physical configuration audits 413
25.2.3 In process audits 414
25.3 Configuration management metrics 414
25.4 The FDA s view of configuration management 414
25.5 Status accounting 415
References 416
Chapter 26 Analysis of field data 417
26.1 Analysis of field service reports 418
26.1.1 The database 418
26.1.2 Data analysis 419
26.2 Failure analysis of field units 421
26.3 Warranty analysis 422
References 422
Appendices 423
Appendix 1 Chi square table 425
Appendix 2 Percent rank tables 427
Appendix 3 Common failure modes 437
Appendix 4 Glossary 447
Index 461
|
| adam_txt |
Table of Contents
Preface v
Section 1
Basics of reliability. 1
Chapter 1 Reliability 3
1.1 History of reliability 3
1.2 The definition of reliability 4
1.3 Quality versus reliability 5
1.4 Reliability versus unreliability 6
1.5 Types of reliability 7
1.5.1 Electronic reliability 7
1.5.1.1 Infant mortality 7
1.5.1.2 Useful life 8
1.5.1.3 Wearout 8
1.5.2 Mechanical reliability 8
1.5.3 Software reliability 9
1.5.4 Device reliability 10
1.6 Optimizing reliability 12
1.7 Reliability assurance 12
1.8 Reliability's effect on medical devices 12
References 13
Chapter 2 The concept of failure 15
2.1 Failure 15
2.2 Causes of failure 16
2.3 The practical aspects of failures 17
2.4 Failure rate 18
2.5 Hardware failures 18
2.5.1 Early failures 19
2.5.2 Chance failures 19
2.5.3 Wearout failures 19
2.6 Software failures 20
2.7 Failures due to human error 21
2.8 Failures from the customer's point of view 21
References 22
xi
A . Contents
5.4 Quality system 81
5.5 Design controls 81
5.6 Document controls 83
5.7 Purchasing controls 84
5.8 Identification and traceability 85
5.9 Production and process controls 85
5.10 Acceptance activities 88
5.11 Non conforming product 89
5.12 Corrective and preventive action 89
5.13 Labeling and packaging controls 90
5.14 Handling, storage, distribution, and installation 91
5.15 Records 92
5.16 Servicing requirements 93
References 94
Chapter 6 Domestic standards 95
6.1 Domestic standards organizations 95
6.1.1 AAMI 95
6.1.2 ANSI 96
6.1.3 ASQC 96
6.1.4 ASTM 96
6.1.5 IEEE 96
6.1.6 IES 96
6.1.7 IPC 97
6.1.8 NEMA 97
6.1.9 NFPA 97
6.1.10 OSHA 97
6.1.11 UL 97
6.2 Software standards and regulations 98
References 99
Chapter 7 International standards 101
7.1 The international notion of standards 102
7.2 The international regulatory scene 103
7.2.1 BSI 103
7.2.2 CEN 103
7.2.3 CENELAC 103
7.2.4 CISPR 104
7.2.5 CSA 104
7.2.6 DIN 104
7.2.7 DoH 104
7.2.8 IEC 105
7.2.9 IEE 105
7.2.10 ISO 105
7.2.11 JSA 105
contents xv
7.2.12 Other Japanese standards organizations 105
7.3 The TickIT program 106
7.4 The Software Quality System Registration program 106
7.5 The ISO guidance documents for ISO 9001 and 9002 107
7.6 Proposed regulatory requirements for Canada 108
7.7 ISO 14000 series 108
7.8 Medical informatics 110
References Ill
Section 3
Specifying the product 113
Chapter 8 The medical device as an entity 115
8.1 What is a medical device? 115
8.1.1 Food and Drug Administration 116
8.1.2 The Medical Device Directives 116
8.2 A brief history of medical devices 117
8.3 Current medical devices 117
References 119
Chapter 9 Defining the device 121
9.1 The product definition process 122
9.1.1 Surveying the customer 123
9.1.2 Defining the company's needs 123
9.1.3 What are the company's competencies? 123
9.1.4 What are the outside competencies? 124
9.1.5 Completing the product definition 124
9.2 Overview of quality function deployment 124
9.3 The QFD process 125
9.3.1 The voice of the customer 125
9.3.2 The technical portion of the matrix 126
9.3.3 Overview of the QFD process 127
9.4 Summary of QFD 131
9.5 The business proposal 133
9.5.1 Project overview, objectives, major milestones,
and schedule 134
9.5.2 Market need and market potential 134
9.5.3 Product proposal 135
9.5.4 Strategic fit 135
9.5.5 Risk analysis and research plan 135
9.5.6 Economic analysis 137
9.5.7 Core project team 137
References 138
xvj Contents
Chapter 10 Requirements engineering 139
10.1 Requirements, design, verification, and validation 140
10.1.1 Refinement of requirements 141
10.1.2 Assimilation of requirements 141
10.1.3 Requirements versus design 143
10.2 The product specification 144
10.3 The reliability goal 145
10.4 Specification review 147
10.5 The design specification 147
10.6 The software quality assurance plan (SQAP) 148
10.6.1 Purpose 149
10.6.2 Reference documents 149
10.6.3 Management 149
10.6.4 Documentation 149
10.6.5 Standards, practices, conventions, and metrics 149
10.6.6 Review and audits 150
10.6.7 Test 150
10.6.8 Problem reporting and corrective action 150
10.6.9 Tools, techniques, and methodologies 150
10.6.10 Code control 150
10.6.11 Media control 150
10.6.12 Supplier control 150
10.6.13 Records collection, maintenance, and retention 151
10.6.14 Training 151
10.6.15 Risk management 151
10.6.16 Additional sections as required 151
10.7 Software requirements specification (SRS) 151
10.7.1 Purpose 151
10.7.2 Scope 152
10.7.3 Definitions, acronyms, and abbreviations 152
10.7.4 References 152
10.7.5 Overview 152
10.7.6 Product perspective 152
10.7.7 Product functions 152
10.7.8 User characteristics 152
10.7.9 General constraints 153
10.7.10 Assumptions and dependencies 153
10.7.11 Specific requirements 153
10.8 The software design description (SDD) 153
10.8.1 Decomposition description 154
10.8.2 Dependency description 154
10.8.3 Interface description 155
10.8.4 Detailed design description 155
References 155
Contents xvii
Chapter 11 Safety and risk management 157
11.1 Risk 158
11.2 Deciding on acceptable risk 160
11.3 Factors important to medical device risk assessment 160
11.3.1 Device design and manufacture 160
11.3.2 Materials 161
11.3.3 Device users 161
11.3.4 Human factors 162
11.3.5 Medical device systems 162
11.4 Risk management 162
11.5 The risk management process 162
11.5.1 Identifying the risk factors 164
11.5.2 Assessing risk probabilities and effects on
the project 164
11.5.3 Developing strategies to mitigate identified risks 165
11.5.4 Monitoring risk factors 165
11.5.5 Invoking a contingency plan 166
11.5.6 Managing the crisis 166
11.5.7 Recovering from the crisis 166
11.6 Tools for risk estimation 166
11.6.1 Hazard/risk analysis 166
11.6.2 Failure mode and effects analysis 169
11.6.2.1 The FMEA process 169
11.6.3 Fault tree analysis 172
11.6.3.1 The fault tree process 172
11.6.3.2 Example of a fault tree analysis 173
References 176
Chapter 12 Liability 177
12.1 Negligence 178
12.2 Strict liability 179
12.3 Breach of warranty 179
12.3.1 Implied warranties 179
12.3.2 Exclusion of warranties 180
12.4 Defects 180
12.5 Failure to warn of dangers 182
12.6 Plaintiff's conduct 182
12.7 Defendant's conduct 183
12.8 Defendant related issues 183
12.9 Manufacturer's and physician's responsibilities 183
12.10 Conclusion 184
References 185
contents
Chapter 13 Intellectual property 187
13.1 Patents 188
13.1.1 What qualifies as a patent 188
13.1.1.1 Patentable subject matter 189
13.1.1.2 Usefulness 189
13.1.1.3 Novelty 189
13.1.1.4 Non obviousness 189
13.1.1.5 Improvement of an existing invention 190
13.1.1.6 A design 190
13.1.2 The patent process 191
13.1.3 Patent claims 192
13.1.4 Protecting your rights as an inventor 192
13.1.5 Patent infringement 193
13.2 Copyrights 194
13.2.1 What can be copyrighted? 195
13.2.2 The copyright process 196
13.2.2.1 Copyright notice 196
13.2.2.2 Copyright registration 197
13.2.3 Copyright duration 197
13.2.4 Protecting your copyright rights 198
13.2.5 Infringement 198
13.3 Trademarks 198
13.3.1 Selecting a trademark 199
13.3.1.1 What is a distinctive trademark? 200
13.3.2 The trademark process 201
13.3.3 Intent to use registration 201
13.3.4 Protecting your trademark rights 202
13.4 Trade secrets 202
13.4.1 What qualifies for trade secrecy 203
13.4.2 Trade secrecy authorship 203
13.4.3 How trade secrets are lost 203
13.4.4 Duration of trade secrets 204
13.4.5 Protecting your trade secret rights 204
13.4.6 A trade secrecy program 204
13.4.7 Use of trade secrecy with copyrights and patents 205
13.4.7.1 Trade secrets and patents 205
13.4.7.2 Trade secrets and copyrights 205
References k 205
Section 4
Designing the product 207
Chapter 14 Six Sigma and product design 209
14.1 Design for Six Sigma 210
14.2 Methodologies 210
Contents xix
14.3 Structure 212
14.4 Design for Six Sigma tools 213
14.4.1 Robust design 213
14.4.1.1 Why use the robust design methodology? 213
14.4.1.2 Typical problems addressed by
robust design 214
14.4.1.3 Robustness strategy 214
14.4.1.3.1 P diagram 216
14.4.1.4 Quality measurement 216
14.4.1.5 Signal to noise (S/N) ratios 216
14.4.1.5.1 Static vs. dynamic
S/N ratios 217
14.4.1.5.2 Steps in robust parameter
design 217
14.4.2 Quality function deployment 218
14.4.3 Robust design failure mode and effects analysis 218
14.4.3.1 Benefits of a robust DFMEA 219
14.4.3.2 The parameter diagram 219
14.4.3.3 Performing a robust DFMEA 221
14.4.3.4 Conclusion 225
14.4.4 Axiomatic design 226
14.4.4.1 What is axiomatic design? 226
14.4.4.2 Mapping of axiomatic design 227
References 229
Chapter 15 Hardware design 231
15.1 Block diagram 232
15.2 Redundancy 232
15.2.1 Active redundancy 233
15.2.2 Standby redundancy 234
15.3 Component selection 235
15.3.1 Component fitness for use 236
15.3.2 Component reliability 236
15.3.3 Component history 237
15.3.4 Component safety 238
15.4 Component derating 238
15.5 Safety margin 239
15.6 Load protection 240
15.7 Environmental protection 240
15.8 Product misuse 240
15.9 Initial reliability prediction 241
15.9.1 Parts count prediction 242
15.9.2 Parts count prediction example 244
15.9.3 Summary of reliability prediction 248
15.10 Design for variation 248
xx|) Contents i
19.8 Conduct user studies 308 I
19.8.1 Observations 308 |
19.8.2 Interviews 308
19.8.3 Focus groups 309
19.8.4 Task analysis 309
19.8.5 Benchmark usability test 310
19.8.6 Write user profile 310
19.8.7 Set up an advisory panel 310
19.9 Set usability goals 310
19.10 Design user interface concepts 311
19.10.1 Develop conceptual model 311
19.10.2 Develop user interface structure 311
19.10.3 Define interaction style 312
19.10.4 Develop screen templates 312
19.10.5 Develop hardware layout 312
19.10.6 Develop a screenplay 312
19.10.7 Develop a refined design 312
19.10.8 Develop a final design 312
19.11 Model the user interface 313
19.12 Test the user interface 313
19.13 Specify the user interface 314
19.13.1 Style guide 314
19.13.2 Screen hierarchy map 314
19.13.3 Screenplay 314
19.13.4 Specification prototype 314
19.13.5 Hardware layouts 315
19.14 Additional human factors design considerations 315
19.14.1 Consistency and simplicity 315
19.14.2 Safety 315
19.14.3 Environmental/organizational considerations 316
19.14.4 Documentation 316
19.14.5 Anthropometry 317
19.14.6 Functional dimensions 317
19.14.7 Psychological elements 319
19.14.8 Workstation design considerations 320
19.14.9 Alarms and signals 320
19.14.10 Labeling 323
19.14.11 Software 324
19.14.12 Data entry 325
19.14.13 Displays 325
19.14.14 Interactive control 327
19.14.15 Feedback '.'.'.'.'.'.'.'.'.'.'.'.'.'.'.'. 328
19.14.16 Prompts 328
19.14.17 Defaults 329
19.14.18 Error management/data protection 329
References i?q
Contents xxiii
Section 5
Testing and data analysis 331
Chapter 20 The basis and types of testing 333
20.1 Testing defined 334
20.2 Parsing test requirements 335
20.3 Test protocol 337
20.4 Test methodology 337
20.4.1 Time testing 337
20.4.2 Event testing 337
20.4.3 Stress testing 337
20.4.4 Environmental testing 338
20.4.5 Time related 338
20.4.6 Failure related 339
20.5 Purpose of the test 339
20.6 Failure definition 339
20.7 Determining sample size and test length 339
20.7.1 Example 20 1 340
20.7.2 Example 20 2 341
20.8 Types of testing 342
20.8.1 Verification 342
20.8.2 Validation 342
20.8.3 Black box 342
20.8.4 White box 343
20.8.5 Hardware testing 343
20.8.6 Software testing 343
20.8.7 Functional testing 344
20.8.8 Robustness testing 345
20.8.9 Stress testing 345
20.8.10 Safety testing 346
20.8.11 Regression testing 347
References 348
Chapter 21 Hardware verification and validation 349
21.1 Standard tests 350
21.1.1 Cycle testing ., 350
21.1.2 Typical use testing 350
21.1.3 10 x 10 testing 350
21.2 Environmental testing 351
21.2.1 Operating temperature testing 352
21.2.2 Storage temperature testing 352
21.2.3 Thermal shock testing 352
21.2.4 Humidity testing 353
21.2.5 Mechanical shock testing 353
a*i» Contents j
21.2.6 Mechanical vibration testing 354 j
21.2.7 Impact testing 354
21.2.8 Electrostatic discharge 355
21.2.9 Electromagnetic compatibility 355
21.3 Accelerated testing 356
21.3.1 Increasing sample size 356
21.3.2 Increasing test severity 356
21.3.3 Example 21 1 357
21.3.4 Example 21 2 358
21.4 Sudden death testing 359
21.4.1 Weibull testing and plotting 359
21.4.1.1 Example 21 3 359
21.4.1.2 Confidence limits 360
21.4.1.3 The shape of Weibull plots 361
21.5 The sudden death test 362
21.5.1 Sudden death example 365
References 369
Chapter 22 Software verification and validation 371
22.1 Allocation of software testing 373
22.2 Verification and validation test method commonality 373
22.3 Validation and test overview 375
22.3.1 Techniques, methodologies, and test approach 375
22.3.2 Software testing requirements 377
22.3.3 Verification and validation reporting 378
22.4 The essentials of software testing 378
22.4.1 The quality of the test process determines the success
of the test effort 379
22.4.2 Prevent defect migration by using early life cycle
testing techniques 379
22.4.3 The time for software testing tools is now 379
22.4.4 A real person must take responsibility for improving
the testing process 380
22.4.5 Testing is a professional discipline requiring trained
and skilled people 380
22.4.6 Cultivate a positive team attitude of creative
destruction 380
References 381
Chapter 23 Analysis of test results 383
23.1 Failure rate 384
23.1.1 Example 23 1 384
23.1.2 Example 23 2 .! 384
23.2 Mean time between failures (MTBF). 385
23.2.1 Time terminated, failed parts replaced 385
Contents xxv
23.2.1.1 Example 23 3 385
23.2.2 Time terminated, no replacement 386
23.2.3 Failure terminated, failed parts replaced 387
23.2.3.1 Example 23 4 387
23.2.4 Failure terminated, no replacement 387
23.2.5 No failures observed 388
23.2.5.1 Example 23 5 388
23.3 Reliability 388
23.3.1 Example 23 6 389
23.3.2 Example 23 7 389
23.4 Confidence level 390
23.4.1 Example 23 8 390
23.5 Confidence limits 390
23.5.1 Time terminated confidence limits 390
23.5.1.1 Example 23 9 391
23.5.2 Failure terminated confidence limits 391
23.6 Minimum life 392
23.7 Graphical analysis 392
23.7.1 Pareto analysis 392
23.7.2 Graphical plotting 393
23.7.2.1 Example 23 10 393
23.7.3 Weibull plotting 394
References 394
Section 6
The manufacturing and maintenance processes . 395
Chapter 24 GMPs and manufacturing 397
24.1 A history of GMPs 398
24.2 The GMP regulation 400
24.2.1 Design controls 400
24.2.2 Purchasing controls 400
24.2.3 Servicing controls 401
24.2.4 Changes in critical device requirements 401
24.2.5 Harmonization 401
24.3 Design for manufacturability 402
24.3.1 The DFM process 402
24.4 Design for assembly 403
24.4.1 Overall design concept 403
24.4.2 Component mounting 403
24.4.3 Test points 403
24.4.4 Stress levels and tolerances 404
24.4.5 PCBs 404
24.4.6 Miscellaneous 404
xxvi Contents j
|
24.4.7 Design for assembly process 404 j
24.5 The manufacturing process 405 ;
24.5.1 Pre production activity 405
24.5.2 The pilot run build 406 ;
24.5.3 The production run 407
24.5.4 Customer delivery 407
References 407
Chapter 25 Configuration management 409
25.1 Configuration identification 410
25.1.1 Functional baseline 410
25.1.2 Allocated baseline 411
25.1.3 Developmental configuration 412
25.1.4 Product baseline 412
25.2 Configuration audits 412
25.2.1 Functional configuration audits 413
25.2.2 Physical configuration audits 413
25.2.3 In process audits 414
25.3 Configuration management metrics 414
25.4 The FDA's view of configuration management 414
25.5 Status accounting 415
References 416
Chapter 26 Analysis of field data 417
26.1 Analysis of field service reports 418
26.1.1 The database 418
26.1.2 Data analysis 419
26.2 Failure analysis of field units 421
26.3 Warranty analysis 422
References 422
Appendices 423
Appendix 1 Chi square table 425
Appendix 2 Percent rank tables 427
Appendix 3 Common failure modes 437
Appendix 4 Glossary 447
Index 461 |
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| author | Fries, Richard C. |
| author_facet | Fries, Richard C. |
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| dewey-ones | 681 - Precision instruments and other devices |
| dewey-raw | 681/.761 |
| dewey-search | 681/.761 |
| dewey-sort | 3681 3761 |
| dewey-tens | 680 - Manufacture of products for specific uses |
| discipline | Handwerk und Gewerbe / Verschiedene Technologien |
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| edition | 2. ed. |
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| index_date | 2024-07-02T15:05:52Z |
| indexdate | 2024-07-09T20:41:02Z |
| institution | BVB |
| isbn | 0824723759 |
| language | English |
| lccn | 2005043942 |
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| spelling | Fries, Richard C. Verfasser aut Reliable design of medical devices Richard Fries 2. ed. Boca Raton [u.a.] CRC/Taylor & Francis 2006 XXVI, 475 S. graph. Darst. 25 cm txt rdacontent n rdamedia nc rdacarrier Includes bibliographical references and index Médecine - Appareils et instruments - Conception et construction Médecine - Appareils et instruments - Fiabilité Médecine - Appareils et instruments - Normes Médecine - Appareils et instruments - Qualité - Contrôle Medical instruments and apparatus Reliability Medical instruments and apparatus Design and construction Medical instruments and apparatus Quality control Medical instruments and apparatus Standards http://www.loc.gov/catdir/enhancements/fy0648/2005043942-d.html Publisher description HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=014874899&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Fries, Richard C. Reliable design of medical devices Médecine - Appareils et instruments - Conception et construction Médecine - Appareils et instruments - Fiabilité Médecine - Appareils et instruments - Normes Médecine - Appareils et instruments - Qualité - Contrôle Medical instruments and apparatus Reliability Medical instruments and apparatus Design and construction Medical instruments and apparatus Quality control Medical instruments and apparatus Standards |
| title | Reliable design of medical devices |
| title_auth | Reliable design of medical devices |
| title_exact_search | Reliable design of medical devices |
| title_exact_search_txtP | Reliable design of medical devices |
| title_full | Reliable design of medical devices Richard Fries |
| title_fullStr | Reliable design of medical devices Richard Fries |
| title_full_unstemmed | Reliable design of medical devices Richard Fries |
| title_short | Reliable design of medical devices |
| title_sort | reliable design of medical devices |
| topic | Médecine - Appareils et instruments - Conception et construction Médecine - Appareils et instruments - Fiabilité Médecine - Appareils et instruments - Normes Médecine - Appareils et instruments - Qualité - Contrôle Medical instruments and apparatus Reliability Medical instruments and apparatus Design and construction Medical instruments and apparatus Quality control Medical instruments and apparatus Standards |
| topic_facet | Médecine - Appareils et instruments - Conception et construction Médecine - Appareils et instruments - Fiabilité Médecine - Appareils et instruments - Normes Médecine - Appareils et instruments - Qualité - Contrôle Medical instruments and apparatus Reliability Medical instruments and apparatus Design and construction Medical instruments and apparatus Quality control Medical instruments and apparatus Standards |
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