{"id":198283,"date":"2024-10-19T12:37:22","date_gmt":"2024-10-19T12:37:22","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir38-2019\/"},"modified":"2024-10-25T05:10:29","modified_gmt":"2024-10-25T05:10:29","slug":"aami-tir38-2019","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir38-2019\/","title":{"rendered":"AAMI TIR38 2019"},"content":{"rendered":"

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.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nAAMI TIR38:2019; Medical device safety assurance case guidance <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Technical Information Report
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
7<\/td>\nCommittee representation <\/td>\n<\/tr>\n
8<\/td>\nForeword <\/td>\n<\/tr>\n
9<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\n1 Purpose
2 Scope
3 Relationship to other standards and FDA guidance <\/td>\n<\/tr>\n
12<\/td>\n4 Terms and definitions <\/td>\n<\/tr>\n
13<\/td>\n5 Regulatory context <\/td>\n<\/tr>\n
14<\/td>\n6 Safety case example for a generic medical device
6.1 Example objective
6.2 Safety case introduction <\/td>\n<\/tr>\n
15<\/td>\nFigure 1 \u2013 General safety case elements
6.3 Proposed model \u2014 Safety case elements <\/td>\n<\/tr>\n
16<\/td>\n6.3.1 Top-level goal
Figure 2 \u2014 Safety case example \u2014 Focus on top-level goal
6.3.2 Contextual Information
6.3.3 Top-level strategy \/ argument elements <\/td>\n<\/tr>\n
18<\/td>\nFigure 3 \u2014 Safety case example <\/td>\n<\/tr>\n
19<\/td>\nFigure 4 \u2013 Expanded safety case example
6.3.4 Proceeding strategy and goal elements <\/td>\n<\/tr>\n
20<\/td>\nTable 1 \u2013 System hazard enumeration
6.3.5 Evidence elements <\/td>\n<\/tr>\n
21<\/td>\n6.3.6 Context, constraint, justifications, assumptions, and definition case elements
6.4 Proposed model \u2013 Example drug delivery safety case
6.4.1 Top-level goal elements \u2014 Example case <\/td>\n<\/tr>\n
22<\/td>\nFigure 4 \u2013 Example \u2014 Top-level goal for syringe safety case
6.4.2 Top-level argument or strategy elements \u2014 Example case
Figure 5 \u2013 Example \u2014 Syringe safety case \u2013 Top-level argument structure <\/td>\n<\/tr>\n
23<\/td>\nTable 2 \u2014 Example system hazard definitions
6.4.3 Iterative development of strategy and goal elements \u2014 Example case
Table 3 \u2014 Enumeration of syringe delivery error hazards <\/td>\n<\/tr>\n
24<\/td>\nFigure 6 \u2014 Insufficient markings\/graduations \u2013 Initiating argument structure <\/td>\n<\/tr>\n
25<\/td>\nFigure 7 \u2014 Absence of Markings \/ Graduations argument structure \u2013 Following from \u201cInsufficient Markings\/Graduations\u201d within Figure 6
Figure 8 \u2014 Causes of markings\/graduations degradation \u2013 Following from Absence of Markings \/ Graduations Argument Structure from Figure 7 <\/td>\n<\/tr>\n
26<\/td>\n6.4.4 Evidence elements \u2014 Example case
Figure 9.1 \u2014 Marking\/graduation degradation due to thermal exposure
Figure 9.2 \u2014 Pre-use causes and controls of marking\/graduation degradation due to thermal exposure <\/td>\n<\/tr>\n
27<\/td>\nFigure 9.3 \u2014 Clinical-use causes and controls of marking\/graduation degradation due to thermal exposure
Figure 9.4 \u2014 Material selection causes and controls of marking\/graduation degradation due to thermal exposure
7 Generation of system and sub-system hazards <\/td>\n<\/tr>\n
28<\/td>\n8 Confidence arguments <\/td>\n<\/tr>\n
29<\/td>\nTable 4 \u2013 Information for confidence argument <\/td>\n<\/tr>\n
30<\/td>\nFigure 10 \u2013 Example \u2013 Combining safety and confidence arguments <\/td>\n<\/tr>\n
31<\/td>\n9 Challenge
10 Common mistakes to avoid
Table 5 \u2014 Superficial argument example <\/td>\n<\/tr>\n
32<\/td>\nTable 6 \u2014 Undefined relationship example
11 Developing a safety case
11.1 Developing arguments
11.1.1 Strategies \/ arguments <\/td>\n<\/tr>\n
33<\/td>\n11.1.2 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 <\/td>\n<\/tr>\n
34<\/td>\n11.2.2.1 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 <\/td>\n<\/tr>\n
35<\/td>\n11.3.4 Identify context, justification and assumptions needed to understand strategy
11.3.5 Elaborate strategy (identify new claims \u2013 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 <\/td>\n<\/tr>\n
36<\/td>\n13 Lifecycle management
14 Maintaining the safety case
15 Styles of safety case notation
15.1 Graphical notations <\/td>\n<\/tr>\n
37<\/td>\nFigure 11 \u2014 Elements of GSN
15.2 Structures <\/td>\n<\/tr>\n
39<\/td>\nAnnex A (informative) Assurance cases and evidence of substantial equivalence <\/td>\n<\/tr>\n
40<\/td>\nAnnex B (informative) Safety case model examples
B.1 General
B.2 Example #1: Syringe design safety case <\/td>\n<\/tr>\n
42<\/td>\nB.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 <\/td>\n<\/tr>\n
44<\/td>\nAnnex C (informative) Tool selection considerations <\/td>\n<\/tr>\n
45<\/td>\nAnnex D (informative) Developing a safety case for an existing product <\/td>\n<\/tr>\n
47<\/td>\nAnnex 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 <\/td>\n<\/tr>\n
48<\/td>\nTable E.1 \u2014 Superficial argument example
Table E.2 \u2014 Undefined relationship example <\/td>\n<\/tr>\n
49<\/td>\nAnnex F (informative) Special consideration for software assurance <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI TIR38:2019 – Medical device safety assurance case guidance<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2019<\/td>\n51<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198285,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198283","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/198283","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/198285"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198283"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198283"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198283"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}