AAMI TIR80002 2 2017
$162.84
AAMI/ISO TIR80002-2:2017 – Medical device software-Part 2: Validation of software for medical device quality systems
| Published By | Publication Date | Number of Pages |
| AAMI | 2017 | 103 |
This document applies to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI/ISO TIR80002-2:2017; Medical device software—Part 2: Validation of software for medical device quality systems |
| 3 | Title page |
| 4 | Copyright information |
| 5 | AAMI Technical Information Report ANSI Technical Report |
| 6 | Contents |
| 7 | Glossary of equivalent standards |
| 8 | Committee representation |
| 10 | Background of AAMI adoption of ISO TR 80002-2 |
| 11 | Foreword |
| 12 | Introduction |
| 13 | 1 Scope 2 Normative references 3 Terms and definitions 4 Software validation discussion 4.1 Definition |
| 14 | 4.2 Confidence-building activities: Tools in the toolbox 4.3 Critical thinking 5 Software validation and critical thinking 5.1 Overview |
| 15 | Figure 1—Life-cycle controls |
| 17 | Figure 2—Life-cycle controls work stream |
| 18 | 5.2 Determine if the software is in scope 5.2.1 Document a high-level definition of the process and use of the software 5.2.2 Regulatory use assessment |
| 19 | 5.2.3 Processes and software extraneous to medical device regulatory requirements 5.3 Development phase 5.3.1 Validation planning 5.3.2 Define 5.3.2.1 Define block requirement |
| 20 | Figure 3—Life-cycle phase: Define block work streams 5.3.2.2 Process requirements |
| 21 | 5.3.2.3 Analysis of process failure risk 5.3.2.4 Validation planning 5.3.2.5 Software intended use 5.3.2.5.1 Elements of intended use |
| 22 | 5.3.2.5.2 Software purpose and intent Table 1—Sample questions and answers |
| 23 | 5.3.2.5.3 Software use requirements 5.3.2.5.4 Software requirements 5.3.3 Implement, test and deploy 5.3.3.1 Required activities |
| 24 | 5.3.3.2 Analysis of software failure risks 5.3.3.3 Validation planning 5.3.3.4 Software implementation (design, development, building and test) |
| 25 | Figure 4—Life-cycle phase: Implement, test and deploy block work streams 5.3.3.5 Validation report 5.3.3.6 Software release |
| 26 | 5.4 Maintain phase 5.4.1 Entering the maintenance phase 5.4.2 Planning for maintenance |
| 27 | 5.4.3 Types of maintenance within the maintain phase 5.4.4 Process changes: Change to risk control measures 5.4.5 Emergency change |
| 28 | 5.4.6 Maintaining for intended use 5.5 Retirement phase |
| 29 | 6 Documentation 7 Prerequisite processes |
| 31 | Annex A (informative) Toolbox A.1 General A.2 Toolbox structure Table A.1—Development phase: Define |
| 33 | Table A.2—Development phase: Implement |
| 34 | Table A.3—Development phase: Test |
| 36 | Table A.4—Development phase: Deploy Table A.5—Maintain phase |
| 38 | Annex B (informative) Risk management and risk-based approach B.1 General B.2 Terminology B.3 Basic principle B.4 Identification of hazardous situations and estimation risks |
| 40 | B.5 Risk evaluation B.6 Risk control B.6.1 Unacceptable risk B.6.2 Risk control measures not affecting the software |
| 41 | B.6.3 Risk control measures affecting the software B.6.4 Verification of risk control measures and evaluation of residual risk |
| 42 | Annex C (informative) Examples |
| 44 | Example 1: Programmable logic controller (PLC) for manufacturing equipment |
| 48 | Example 2: Automated welding system |
| 50 | Example 3: Automated welding process control system |
| 51 | Table C.1—Example 3—Process requirements |
| 52 | Table C.2—Example 3—Analysis of process failure risk Table C.3—Example 3—Software purpose and intent |
| 53 | Table C.4—Example 3—Validation planning Table C.5—Example 3—Software use requirements and software requirements |
| 54 | Table C.6—Example 3—Analysis of software failure risks Table C.7—Example 3—Validation planning |
| 55 | Table C.8—Example 3—Software implementation Table C.9—Example 3—Validation report Table C.10—Example 3—Software release Table C.11—Example 3—Analysis of change |
| 56 | Table C.12—Example 3—Maintenance validation planning Table C.13—Example 3—Software maintenance Table C.14—Example 3—Retirement of software |
| 58 | Example 4: C/C++ language compiler Figure C.1—Implementation of class C medical device software |
| 62 | Example 5: Automated software test system |
| 66 | Example 6: A simple spreadsheet |
| 68 | Table C.15—Example 6—Risks and mitigations |
| 70 | Example 7: A (not so) simple spreadsheet |
| 74 | Example 8: Parametric sterilizer |
| 78 | Example 9: Nonconforming material reporting system—Total system upgrade |
| 84 | Example 10: Software for scheduling non-conforming material report (NCMR) review board meetings |
| 86 | Example 11: Approved vendor list system |
| 90 | Example 12: Calibration management software |
| 93 | Table C.16—Example 12—Risk analysis |
| 95 | Table C.17—Example 12—Risk evaluation and control |
| 103 | Bibliography |
