AAMI TIR38 2019
$140.32
AAMI TIR38:2019 – Medical device safety assurance case guidance
| Published By | Publication Date | Number of Pages |
| AAMI | 2019 | 51 |
Provides guidance on how to complete an Assurance Case Report in order to comply with the new additional FDA pre-market requirements for infusion pumps. Includes a detailed but strictly hypothetical example from the medical device domain.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI TIR38:2019; Medical device safety assurance case guidance |
| 3 | Title page |
| 4 | AAMI Technical Information Report Copyright information |
| 5 | Contents |
| 7 | Committee representation |
| 8 | Foreword |
| 9 | Introduction |
| 11 | 1 Purpose 2 Scope 3 Relationship to other standards and FDA guidance |
| 12 | 4 Terms and definitions |
| 13 | 5 Regulatory context |
| 14 | 6 Safety case example for a generic medical device 6.1 Example objective 6.2 Safety case introduction |
| 15 | Figure 1 – General safety case elements 6.3 Proposed model — Safety case elements |
| 16 | 6.3.1 Top-level goal Figure 2 — Safety case example — Focus on top-level goal 6.3.2 Contextual Information 6.3.3 Top-level strategy / argument elements |
| 18 | Figure 3 — Safety case example |
| 19 | Figure 4 – Expanded safety case example 6.3.4 Proceeding strategy and goal elements |
| 20 | Table 1 – System hazard enumeration 6.3.5 Evidence elements |
| 21 | 6.3.6 Context, constraint, justifications, assumptions, and definition case elements 6.4 Proposed model – Example drug delivery safety case 6.4.1 Top-level goal elements — Example case |
| 22 | Figure 4 – Example — Top-level goal for syringe safety case 6.4.2 Top-level argument or strategy elements — Example case Figure 5 – Example — Syringe safety case – Top-level argument structure |
| 23 | Table 2 — Example system hazard definitions 6.4.3 Iterative development of strategy and goal elements — Example case Table 3 — Enumeration of syringe delivery error hazards |
| 24 | Figure 6 — Insufficient markings/graduations – Initiating argument structure |
| 25 | Figure 7 — Absence of Markings / Graduations argument structure – Following from “Insufficient Markings/Graduations” within Figure 6 Figure 8 — Causes of markings/graduations degradation – Following from Absence of Markings / Graduations Argument Structure from Figure 7 |
| 26 | 6.4.4 Evidence elements — Example case Figure 9.1 — Marking/graduation degradation due to thermal exposure Figure 9.2 — Pre-use causes and controls of marking/graduation degradation due to thermal exposure |
| 27 | Figure 9.3 — Clinical-use causes and controls of marking/graduation degradation due to thermal exposure Figure 9.4 — Material selection causes and controls of marking/graduation degradation due to thermal exposure 7 Generation of system and sub-system hazards |
| 28 | 8 Confidence arguments |
| 29 | Table 4 – Information for confidence argument |
| 30 | Figure 10 – Example – Combining safety and confidence arguments |
| 31 | 9 Challenge 10 Common mistakes to avoid Table 5 — Superficial argument example |
| 32 | Table 6 — Undefined relationship example 11 Developing a safety case 11.1 Developing arguments 11.1.1 Strategies / arguments |
| 33 | 11.1.2 Argumentation and 4-Part Harmony 11.1.3 Assumptions / context / constraint / justification 11.2 Developing evidence 11.2.1 Evidence 11.2.2 Suitability of evidence |
| 34 | 11.2.2.1 Relevance 11.2.2.2 Trustworthiness 11.2.2.3 Independence 11.3 General Assurance Case Development Process 11.3.1 Identify a claim 11.3.2 Define information needed to clarify the claim 11.3.3 Identify strategy to support the claim |
| 35 | 11.3.4 Identify context, justification and assumptions needed to understand strategy 11.3.5 Elaborate strategy (identify new claims – back to step 1), or proceed to 11.3.6 11.3.6 Identify basic solution 12 Safety cases and risk management 12.1 Similarities between assurance case development and risk management 12.2 ANSI/AAMI/ISO 14971 and safety cases |
| 36 | 13 Lifecycle management 14 Maintaining the safety case 15 Styles of safety case notation 15.1 Graphical notations |
| 37 | Figure 11 — Elements of GSN 15.2 Structures |
| 39 | Annex A (informative) Assurance cases and evidence of substantial equivalence |
| 40 | Annex B (informative) Safety case model examples B.1 General B.2 Example #1: Syringe design safety case |
| 42 | B.3 Example #2: Air in line safety case B.3.1 General Information about the example B.3.2 Embolus sub-claim: Air emboli hazard is adequately addressed |
| 44 | Annex C (informative) Tool selection considerations |
| 45 | Annex D (informative) Developing a safety case for an existing product |
| 47 | Annex E (informative) Lessons learned regarding safety cases E.1 Lessons learned from other industries E.2 Lessons from academia E.3 Experiences from medical device safety cases |
| 48 | Table E.1 — Superficial argument example Table E.2 — Undefined relationship example |
| 49 | Annex F (informative) Special consideration for software assurance |
