{"id":198263,"date":"2024-10-19T12:37:17","date_gmt":"2024-10-19T12:37:17","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir80001-2-1-2012\/"},"modified":"2024-10-25T05:10:25","modified_gmt":"2024-10-25T05:10:25","slug":"aami-tir80001-2-1-2012","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir80001-2-1-2012\/","title":{"rendered":"AAMI TIR80001 2 1 2012"},"content":{"rendered":"

Step-by-step guide to help in the application of risk management when creating or changing a medical IT-network.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/IEC TIR80001-2-1:2012, Application of risk management for IT-networks incorporating medical devices \u2014 Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nCopyright information <\/td>\n<\/tr>\n
5<\/td>\nAAMI Technical Information Report
ANSI Technical Report <\/td>\n<\/tr>\n
6<\/td>\nContents <\/td>\n<\/tr>\n
9<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
12<\/td>\nCommittee representation <\/td>\n<\/tr>\n
13<\/td>\nBackground of ANSI\/AAMI adoption of IEC\/TR 80001-2-1:2012 <\/td>\n<\/tr>\n
14<\/td>\nFOREWORD <\/td>\n<\/tr>\n
16<\/td>\nINTRODUCTION <\/td>\n<\/tr>\n
17<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
23<\/td>\n4 Prerequisites
5 Study of terms used in risk management
5.1 Overview <\/td>\n<\/tr>\n
24<\/td>\n5.2 Hazards
5.3 Hazardous situations <\/td>\n<\/tr>\n
25<\/td>\n5.4 Foreseeable sequences of events and causes
5.5 Unintended consequence <\/td>\n<\/tr>\n
26<\/td>\n5.6 Risk control measures (mitigations) <\/td>\n<\/tr>\n
27<\/td>\n5.7 Degrees of risk
5.8 Checking wording <\/td>\n<\/tr>\n
28<\/td>\n6 The steps
6.1 Overview of the steps
6.2 A basic example using the 10 steps
6.2.1 General
6.2.2 Initial risk \u2013 Steps 1 \u2013 5 (Figure 2) <\/td>\n<\/tr>\n
29<\/td>\n6.2.3 Risk control and final risk \u2013 Steps 6 \u2013 10 (Figure 3) <\/td>\n<\/tr>\n
32<\/td>\n7 IEC 80001-1:2010, Subclause 4.4: Step by step
7.1 General
7.2 Application of Subclause 4.4.1: Document all risk management elements
7.3 Note about risk evaluation
7.4 The 10-step process
7.4.1 STEP 1: Identify hazards and hazardous situations <\/td>\n<\/tr>\n
33<\/td>\n7.4.2 STEP 2: Identify causes and resulting hazardous situations
7.4.2.1 General
7.4.2.2 Multiple causes per hazardous situation <\/td>\n<\/tr>\n
34<\/td>\n7.4.2.3 Multiple hazardous situations per cause
7.4.3 STEP 3: Determine unintended consequences and estimate the potential severities
7.4.4 STEP 4: Estimate the probability of unintended consequence
7.4.4.1 General
7.4.4.2 Probability estimations <\/td>\n<\/tr>\n
35<\/td>\n7.4.5 STEP 5: Evaluate risk <\/td>\n<\/tr>\n
36<\/td>\n7.4.6 STEP 6: Identify and document proposed risk control measures and re-evaluate risk (return to Step 3)
7.4.6.1 General
7.4.6.2 Identify risk control measures <\/td>\n<\/tr>\n
37<\/td>\n7.4.6.3 Select risk control measure
7.4.6.4 Re-evaluate risk
7.4.6.5 Risk\/benefit analysis
7.4.7 STEP 7: Implement risk control measures
7.4.8 STEP 8: Verify risk control measures
7.4.8.1 General <\/td>\n<\/tr>\n
38<\/td>\n7.4.8.2 Verification of effectiveness
7.4.8.3 Verification of implementation
7.4.9 STEP 9: Evaluate any new risks arising from risk control <\/td>\n<\/tr>\n
39<\/td>\n7.4.10 STEP 10: Evaluate and report overall residual risk
7.5 The steps and their relationship to IEC 80001-1 and ISO 14971 <\/td>\n<\/tr>\n
41<\/td>\n8 Practical examples
8.1 General
8.2 Example 1: Wireless patient monitoring during patient transport
8.2.1 Full description of context
8.2.2 Description of network under analysis
8.2.3 The 10 Steps <\/td>\n<\/tr>\n
44<\/td>\n8.3 Example 2: Remote ICU \/ Distance medicine
8.3.1 Full description of context
8.3.2 Description of network under analysis
8.3.3 The 10 Steps <\/td>\n<\/tr>\n
47<\/td>\n8.4 Example 3: Post Anesthesia Care Unit (PACU)
8.4.1 Full description of context
8.4.2 Description of network under analysis <\/td>\n<\/tr>\n
48<\/td>\n8.4.3 The 10 Steps <\/td>\n<\/tr>\n
53<\/td>\n8.5 Example 4: Ultrasound \u2013 Operating System (OS) vulnerability
8.5.1 Full description of context
8.5.2 Description of network under analysis
8.5.3 The 10 Steps <\/td>\n<\/tr>\n
57<\/td>\nAnnex A (informative) Common hazards, hazardous situations, and causes to consider in medical IT-networks
A.1 Typical hazards in medical it-networks
A.2 Types of hazardous situations <\/td>\n<\/tr>\n
58<\/td>\nA.3 Common causes in medical IT-networks
A.4 Relationship between required network characteristics and hazards <\/td>\n<\/tr>\n
59<\/td>\nA.5 Relationship between hazards, foreseeable sequences, and causes <\/td>\n<\/tr>\n
61<\/td>\nA.6 Hazards, causes, foreseeable sequences, and hazardous situations <\/td>\n<\/tr>\n
62<\/td>\nAnnex B (informative) List of questions to consider when identifying hazards of the medical IT-network <\/td>\n<\/tr>\n
63<\/td>\nAnnex C (informative) Layers of medical IT-networks where errors can be found
C.1 Overview
C.2 Errors and faults <\/td>\n<\/tr>\n
66<\/td>\nAnnex D (informative) Probability, severity, and risk acceptability scales used in the examples in this technical report <\/td>\n<\/tr>\n
69<\/td>\nAnnex E (informative) Monitoring risk mitigation effectiveness
E.1 Overview
E.2 Verify the effectiveness of risk control measures
E.3 Verify the effectiveness of inherent key property control by design <\/td>\n<\/tr>\n
70<\/td>\nE.4 Verify the effectiveness of protective measures
E.5 Verify the effectiveness of information for key properties to mitigate risk
E.6 Verification of the design and execution of the risk management process <\/td>\n<\/tr>\n
72<\/td>\nAnnex F (informative) Risk analyzing small changes in a medical IT-network <\/td>\n<\/tr>\n
73<\/td>\nAnnex G (informative) Example of Change Window Form <\/td>\n<\/tr>\n
74<\/td>\nAnnex H (informative) Template for examples <\/td>\n<\/tr>\n
76<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI\/IEC TIR80001-2-1:2012 – Application of risk management for IT-networks incorporating medical device-Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2012<\/td>\n76<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198266,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198263","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\/198263","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\/198266"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198263"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198263"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198263"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}