The Medical Device Validation Handbook
vii
Tables
Table 3-1. Gap/Remediation Scope................................................................................................ 24
Table 3-2. Scope Change Scenarios................................................................................................. 24
Table 3-3. Internal Gaps.................................................................................................................. 25
Table 3-4. External Gaps................................................................................................................. 26
Table 3-5. ISO 11607-1:2006 vs. ISO 11607-1:2019 Requirements............................................... 27
Table 4-1. Required TMV Elements............................................................................................... 42
Table 4-2. Basis for 30% GRR Rule Comparison of Observed to Actual Cp. ...............................53
Table 5-1. Strategy and Selection of Experimental Designs............................................................ 59
Table 5-2. Design Strategies by Nuisance Factors. ..........................................................................60
Table 5-3. Randomized Block Design............................................................................................. 60
Table 5-4. Plackett-Burman Design................................................................................................ 63
Table 5-5. Full Factorial Design. .....................................................................................................64
Table 5-6. Temperature Change Effect. ..........................................................................................65
Table 5-7. Expanded Design with Interaction Terms...................................................................... 65
Table 5-8. Interaction Effects Calculation Example........................................................................ 65
Table 5-9. Full Factorial Effects Summary. .....................................................................................66
Table 5-10. A Fractional Factorial Design......................................................................................... 66
Table 6-1. ISO Sterilization Standards/Guidance Documents....................................................... 78
Table 6-2. FDA Sterilization Grouping. .........................................................................................79
Table 6-3. Dry Heat IQ................................................................................................................... 81
Table 6-4. Common OQ Activities................................................................................................. 83
Table 6-5. Methods to Establish Sterilization Dose........................................................................ 85
Table 6-6. VDmax Methods............................................................................................................ 86
Table 6-7. Known Defined BIs........................................................................................................ 87
Table 6-8. Dose Audits.................................................................................................................... 91
Table 7-1. DMAIC Model.............................................................................................................. 98
Table 7-2. DMADV Model. ...........................................................................................................99
Table 7-3. SIPOC Map................................................................................................................. 100
Table 9-1. TIR 30 Acceptance Criteria. ........................................................................................130
Table 10-1. Examples of Risk-Based Testing. .................................................................................150
Table 11-1. UDI Impact on Existing Regulations........................................................................... 163
Table 11-2. 62 Attributes for Each Device Identifier. .....................................................................168
Table 13-1. Statistical Error............................................................................................................ 188
Table 13-2. CTQ Risk Levels. ........................................................................................................189
Table 13-3. K-Values From ISO-16269-6....................................................................................... 195
Table 13-4. Noninferiority Sample Sizes......................................................................................... 197
Table 13-5. Confidence and Reliability for C=0 Plans. ...................................................................198
Table 14-1. NASA Modeling and Simulation Risk Matrix............................................................. 209
Table 18-1. Issues Leading to a Worst-Case Event......................................................................... 254
vii
Tables
Table 3-1. Gap/Remediation Scope................................................................................................ 24
Table 3-2. Scope Change Scenarios................................................................................................. 24
Table 3-3. Internal Gaps.................................................................................................................. 25
Table 3-4. External Gaps................................................................................................................. 26
Table 3-5. ISO 11607-1:2006 vs. ISO 11607-1:2019 Requirements............................................... 27
Table 4-1. Required TMV Elements............................................................................................... 42
Table 4-2. Basis for 30% GRR Rule Comparison of Observed to Actual Cp. ...............................53
Table 5-1. Strategy and Selection of Experimental Designs............................................................ 59
Table 5-2. Design Strategies by Nuisance Factors. ..........................................................................60
Table 5-3. Randomized Block Design............................................................................................. 60
Table 5-4. Plackett-Burman Design................................................................................................ 63
Table 5-5. Full Factorial Design. .....................................................................................................64
Table 5-6. Temperature Change Effect. ..........................................................................................65
Table 5-7. Expanded Design with Interaction Terms...................................................................... 65
Table 5-8. Interaction Effects Calculation Example........................................................................ 65
Table 5-9. Full Factorial Effects Summary. .....................................................................................66
Table 5-10. A Fractional Factorial Design......................................................................................... 66
Table 6-1. ISO Sterilization Standards/Guidance Documents....................................................... 78
Table 6-2. FDA Sterilization Grouping. .........................................................................................79
Table 6-3. Dry Heat IQ................................................................................................................... 81
Table 6-4. Common OQ Activities................................................................................................. 83
Table 6-5. Methods to Establish Sterilization Dose........................................................................ 85
Table 6-6. VDmax Methods............................................................................................................ 86
Table 6-7. Known Defined BIs........................................................................................................ 87
Table 6-8. Dose Audits.................................................................................................................... 91
Table 7-1. DMAIC Model.............................................................................................................. 98
Table 7-2. DMADV Model. ...........................................................................................................99
Table 7-3. SIPOC Map................................................................................................................. 100
Table 9-1. TIR 30 Acceptance Criteria. ........................................................................................130
Table 10-1. Examples of Risk-Based Testing. .................................................................................150
Table 11-1. UDI Impact on Existing Regulations........................................................................... 163
Table 11-2. 62 Attributes for Each Device Identifier. .....................................................................168
Table 13-1. Statistical Error............................................................................................................ 188
Table 13-2. CTQ Risk Levels. ........................................................................................................189
Table 13-3. K-Values From ISO-16269-6....................................................................................... 195
Table 13-4. Noninferiority Sample Sizes......................................................................................... 197
Table 13-5. Confidence and Reliability for C=0 Plans. ...................................................................198
Table 14-1. NASA Modeling and Simulation Risk Matrix............................................................. 209
Table 18-1. Issues Leading to a Worst-Case Event......................................................................... 254