{"id":198343,"date":"2024-10-19T12:37:34","date_gmt":"2024-10-19T12:37:34","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir80001-2-7-2014\/"},"modified":"2024-10-25T05:10:40","modified_gmt":"2024-10-25T05:10:40","slug":"aami-tir80001-2-7-2014","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir80001-2-7-2014\/","title":{"rendered":"AAMI TIR80001 2 7 2014"},"content":{"rendered":"

The purpose of this technical report is to provide guidance to HDOs on self-assessment of their conformance against IEC 80001-1. The purpose of this Technical Report is to: 1) provide guidance to HDOs on self-assessment of their conformance against IEC 80001-1 2) provide an exemplar assessment method which can be used by HDOs in varying contexts to assess themselves against IEC 80001-1 3) define a PRM comprising a set of processes, described in terms of process purpose and outcomes that demonstrate coverage of the requirements of IEC 80001-1 4) define a PAM that meets the requirements of ISO\/IEC 15504-2 and that supports the performance of an assessment by providing indicators for guidance on the interpretation of the process purposes and outcomes as defined in IEC 80001-1 (PRM) and the process attributes as defined in ISO\/IEC 15504-2 This technical report does not introduce any requirements in addition to those expressed in IEC 80001-1<\/p>\n

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1<\/td>\nANSI\/AAMI\/IEC TIR80001-2-7:2014, Application of risk management for IT-networks incorporating medical \u2014 Application guidance \u2014 Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1 <\/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
7<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
8<\/td>\nCommittee representation <\/td>\n<\/tr>\n
9<\/td>\nBackground of AAMI adoption of ISO TR 80001-2-7 Ed.1 <\/td>\n<\/tr>\n
10<\/td>\nForeword <\/td>\n<\/tr>\n
11<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
2 Normative References
3 Terms and Definitions <\/td>\n<\/tr>\n
14<\/td>\n4 Assessment Method
4.1 Prerequisites
4.2 Assessment Method Overview
Figure 1 \u2014 PAM Processes \u2013 Assessment Method
4.3 Assessment Stages <\/td>\n<\/tr>\n
15<\/td>\n4.3.1 Stage 1 \u2013 Defining Assessment Scope
4.3.2 Stage 2 \u2013 Stakeholder Involvement
4.3.3 Stage 3 \u2013 Information Collection and Evaluation
4.3.4 Stage 4 \u2013 Findings Report
4.3.5 Stage 5 \u2013 Presentation of Findings <\/td>\n<\/tr>\n
16<\/td>\n4.3.6 Stage 6 \u2013 Improvement Plan (optional)
4.3.7 Stage 7- Follow-up Assessment (optional)
4.4 Process Attribute Rating Scale <\/td>\n<\/tr>\n
17<\/td>\n4.5 Capability Levels
4.6 Tailoring the Assessment Method <\/td>\n<\/tr>\n
18<\/td>\nAnnex A: Assessment Method
A.1 Exemplar assessment questions
A.1.1 Introduction <\/td>\n<\/tr>\n
19<\/td>\nA.1.2 MRM.1 Medical IT-Network Risk Management Process
Table A.1 \u2014 MRM.1 BP1 <\/td>\n<\/tr>\n
20<\/td>\nTable A.2 \u2014 MRM.1 BP2
Table A.3 \u2014 MRM.1 BP3 <\/td>\n<\/tr>\n
21<\/td>\nTable A.4 \u2014 MRM.1 BP4
Table A.5 \u2014 MRM.1 BP5 <\/td>\n<\/tr>\n
22<\/td>\nTable A.6 \u2014 MRM.1 BP6 <\/td>\n<\/tr>\n
23<\/td>\nA.1.3 MRM 1.1 Risk Analysis & Evaluation Process
Table A.7 \u2014 MRM1.1 BP1 <\/td>\n<\/tr>\n
24<\/td>\nTable A.8 \u2014 MRM1.1 BP2
Table A.9 \u2014 MRM1.1 BP3
Table A.10 \u2014 MRM1.1 BP4 <\/td>\n<\/tr>\n
25<\/td>\nA.1.4 MRM 1.2 Risk Control Process
Table A.11 \u2014 MRM1.2 BP1
Table A.12 \u2014 MRM1.2 BP2 <\/td>\n<\/tr>\n
26<\/td>\nTable A.13 \u2014 MRM1.2 BP3
Table A.14 \u2014 MRM1.2 BP4 <\/td>\n<\/tr>\n
27<\/td>\nTable A.15 \u2014 MRM1.2 BP5
Table A.16 \u2014 MRM1.2 BP6 <\/td>\n<\/tr>\n
28<\/td>\nTable A.17 \u2014 MRM1.2 BP7
A.1.5 MRM 1.3 Residual Risk Process
Table A.18 \u2014 MRM1.3 BP1 <\/td>\n<\/tr>\n
29<\/td>\nTable A.19 \u2014 MRM1.3 BP2
Table A.20 \u2014 MRM1.3 BP3
Table A.21 \u2014 MRM1.3 BP4
Table A.22 \u2014 MRM1.3 BP5 <\/td>\n<\/tr>\n
30<\/td>\nTable A.23 \u2014 MRM1.3 BP6
A.1.6 CRCM.1 Change Release & Configuration Management Process
Table A.24 \u2014 CRCM.1 BP1
Table A.25 \u2014 CRCM.1 BP2 <\/td>\n<\/tr>\n
31<\/td>\nTable A.26 \u2014 CRCM.1 BP3
Table A.27 \u2014 CRCM.1 BP4
Table A.28 \u2014 CRCM.1 BP5 <\/td>\n<\/tr>\n
32<\/td>\nCRCM.2 Decision on how to apply Risk Management Process
Table A.29 \u2014 CRCM.2 BP1
Table A.30 \u2014 CRCM.2 BP2
Table A.31 \u2014 CRCM.2 BP3
Table A.32 \u2014 CRCM.2 BP4 <\/td>\n<\/tr>\n
33<\/td>\nTable A.33 \u2014 CRCM.2 BP5
Table A.34 \u2014 CRCM.2 BP6 <\/td>\n<\/tr>\n
34<\/td>\nTable A.35 \u2014 CRCM.2 BP7 <\/td>\n<\/tr>\n
35<\/td>\nTable A.36 \u2014 CRCM.2 BP8
Table A.37 \u2014 CRCM.2 BP9
A.1.6 CRCM.3 Go Live Process
Table A.38 \u2014 CRCM.3 BP1
Table A.39 \u2014 CRCM.3 BP2
Table A.40 \u2014 CRCM.3 BP3 <\/td>\n<\/tr>\n
36<\/td>\nA.1.7 LNRM.1 Monitoring Process
Table A.41 \u2014 LNRM.1 BP1
Table A.42 \u2014 LNRM.1 BP2
Table A.43 \u2014 LNRM.1 BP3 <\/td>\n<\/tr>\n
37<\/td>\nA.1.8 LNRM.2 Event Management Process
Table A.44 \u2014 LNRM.2 BP.1
Table A.45 \u2014 LNRM.2 BP.2
Table A.46 \u2014 LNRM.2 BP.3
Table A.47 \u2014 LNRM.2 BP.4
Table A.48 \u2014 LNRM.2 BP.5 <\/td>\n<\/tr>\n
38<\/td>\nA.1.9 MDP.1 Medical IT-Network Planning Process
Table A.49 \u2014 MDP.1 BP.1
Table A.50 \u2014 MDP.1 BP.2 <\/td>\n<\/tr>\n
39<\/td>\nTable A.51 \u2014 MDP.1 BP.3
Table A.52 \u2014 MDP.1 BP.4
Table A.53 \u2014 MDP.1 BP.5
Table A.54 \u2014 MDP.1 BP.6 <\/td>\n<\/tr>\n
40<\/td>\nTable A.55 \u2014 MDP.1 BP.7
A.1.10 MDP.2 Medical IT-Network Documentation Process
Table A.56 (1 of 2) \u2014 MDP.2 BP.1 <\/td>\n<\/tr>\n
41<\/td>\nTable A.56 (2 of 2) \u2013 MDP.2 BP.1
Table A.57 \u2014 MDP.2 BP.2 <\/td>\n<\/tr>\n
42<\/td>\nTable A.58 \u2014 MDP.2 BP.3 <\/td>\n<\/tr>\n
43<\/td>\nA.1.11 MDP.3 Responsibility Agreements Process
Table A.59 \u2014 MDP.3 BP.1 <\/td>\n<\/tr>\n
44<\/td>\nTable A.60 \u2014 MDP.3 BP.2 <\/td>\n<\/tr>\n
45<\/td>\nTable A.61 \u2014 MDP.3 BP.3
A.1.12 MDP.4 Risk Management Policy Process
Table A.62 \u2014 MDP.4 BP.1
Table A.63 \u2014 MDP.4 BP.2 <\/td>\n<\/tr>\n
46<\/td>\nTable A.64 \u2014 MDP.4 BP.2
Table A.65 \u2014 MDP.4 BP.4 <\/td>\n<\/tr>\n
47<\/td>\nA.1.13 MDP.5 Organisational Risk Management Process
Table A.66 \u2014 MDP.5 BP.1
Table A.67 \u2014 MDP.5 BP.2 <\/td>\n<\/tr>\n
48<\/td>\nTable A.68 \u2014 MDP.5 BP.3
Table A.69 \u2014 MDP.5 BP.4 <\/td>\n<\/tr>\n
49<\/td>\nA.2 Exemplar Assessment Documentation:
A.2.1 Introduction
A.2.2 Assessment Details
Table A.70 \u2014 Assessment Details Template <\/td>\n<\/tr>\n
50<\/td>\nA.2.3 Assessment Interview Template
Table A.71 \u2014 Assessment Interview Template
A.2.4 Findings Report
Table A.72 \u2014 Findings Report Template <\/td>\n<\/tr>\n
51<\/td>\nAnnex B: Process Reference Model
B.1 Introduction
B.2 Overview of the Process Reference Model
B.2.1 General <\/td>\n<\/tr>\n
52<\/td>\nFigure B.1 \u2014 Processes in the Process Reference Model
B.2.2 Process Descriptions <\/td>\n<\/tr>\n
53<\/td>\nB.3 Process Descriptions
B.3.1 MRM.1 Medical IT-Network Risk Management Process <\/td>\n<\/tr>\n
54<\/td>\nB.3.2 MRM.1.1 Risk Analysis & Evaluation Process <\/td>\n<\/tr>\n
55<\/td>\nB.3.3 MRM.1.2 Risk Control Process <\/td>\n<\/tr>\n
56<\/td>\nB.3.4 MRM.1.3 Residual Risk Process <\/td>\n<\/tr>\n
57<\/td>\nB.3.5 CRCM.1 Change Release & Configuration Management Process
B.3.6 CRCM.2 Decision on how to apply Risk Management Process <\/td>\n<\/tr>\n
58<\/td>\nB.3.7 CRCM.3 Go Live Process
B.3.8 LNRM.1 Monitoring Process <\/td>\n<\/tr>\n
59<\/td>\nB.3.9 LNRM.2 Event Management Process
B.3.10 MDP.1 Medical IT-Network Planning Process <\/td>\n<\/tr>\n
60<\/td>\nB.3.11 MDP.2 Medical IT-Network Documentation Process <\/td>\n<\/tr>\n
61<\/td>\nB.3.12 MDP.3 Responsibility Agreements Process
B.3.13 MDP.4 Risk Management Policy Process <\/td>\n<\/tr>\n
62<\/td>\nB.3.14 MDP.5 Organisational Risk Management Process <\/td>\n<\/tr>\n
63<\/td>\nB.4 PRM Conformity to ISO\/IEC 15504-2
B.4.1 General
B.4.2 Requirements for Process Reference Models <\/td>\n<\/tr>\n
64<\/td>\nB.4.3 Process descriptions <\/td>\n<\/tr>\n
65<\/td>\nAnnex C: Process Assessment Model
C.1 Introduction
Figure C.1 \u2014 Relationship to IEC 80001-1, IEC 80001-1(PRM) and ISO\/IEC 15504-2 <\/td>\n<\/tr>\n
66<\/td>\nC.2 Overview of the exemplar Process Assessment Model
C.2.1 Introduction to Overview
Figure C.2 \u2014 Relationship between the Process Assessment Model and its inputs <\/td>\n<\/tr>\n
67<\/td>\nC.2.2 Structure of the exemplar Process Assessment Model
C.2.2.1 Processes
Figure C.3 \u2014 Processes in the Process Reference Model
C.2.2.2 Process dimension
C.2.2.3 Capability dimension <\/td>\n<\/tr>\n
68<\/td>\nTable C.1 \u2014 Capability levels and process attributes
C.3 Assessment Indicators
C.3.1 Overview <\/td>\n<\/tr>\n
69<\/td>\nFigure C.4 \u2014 Assessment Indicators <\/td>\n<\/tr>\n
70<\/td>\nC.3.2 Process Capability Indicators
Figure C.5 \u2014 Process capability indicators <\/td>\n<\/tr>\n
71<\/td>\nC.3.3 Process Performance Indicators
C.4 Measuring process capability <\/td>\n<\/tr>\n
72<\/td>\nFigure C.6 \u2014 Relationship between assessment indicators and process capability
C.5 The process dimension and process performance indicators (Level 1)
C.5.1 General <\/td>\n<\/tr>\n
73<\/td>\nC.5.2 Medical IT-Network Risk Management Process
C.5.3 Risk Analysis & Evaluation Process <\/td>\n<\/tr>\n
74<\/td>\nC.5.4 Risk Control Process <\/td>\n<\/tr>\n
75<\/td>\nC.5.5 Residual Risk Process <\/td>\n<\/tr>\n
76<\/td>\nC.5.6 Change Release & Configuration Management Process <\/td>\n<\/tr>\n
77<\/td>\nC.5.7 Decision on how to apply Risk Management Process <\/td>\n<\/tr>\n
78<\/td>\nC.5.8 Go Live Process
C.5.9 Monitoring Process <\/td>\n<\/tr>\n
79<\/td>\nC.5.10 Event Management Process
C.5.11 Medical IT-Network Planning Process <\/td>\n<\/tr>\n
80<\/td>\nC.5.12 Medical IT-Network Documentation Process <\/td>\n<\/tr>\n
81<\/td>\nC.5.13 Responsibility Agreements Process <\/td>\n<\/tr>\n
82<\/td>\nC.5.14 Risk Management Policy Process
C.5.15 Organisational Risk Management Process <\/td>\n<\/tr>\n
83<\/td>\nC.6 Process capability indicators (Level 1 to 5) <\/td>\n<\/tr>\n
99<\/td>\nC.7 Conformity of the exemplar Process Assessment Model
C.7.1 General
C.7.2 Introduction <\/td>\n<\/tr>\n
100<\/td>\nC.7.3 Process Assessment Model Scope
C.7.4 Process Assessment Model elements and indicators
C.7.5 Mapping Process Assessment Models to Process Reference Models <\/td>\n<\/tr>\n
102<\/td>\nC.7.6 Expression of assessment results
C.8 Work Product characteristics
C.8.1 General <\/td>\n<\/tr>\n
103<\/td>\nTable C.3 \u2014 Input\/Output identificatioTable C.3 \u2014 Input\/Output identificatio
C.8.2 Generic Work Products
C.8.3 Specific inputs and outputs <\/td>\n<\/tr>\n
115<\/td>\nAnnex D: Abbreviations and Process Identifiers
D.1 Abbreviations:
D.2 Process Group
D.3 Process IDs <\/td>\n<\/tr>\n
116<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI\/IEC TIR80001-2-7:2014 – Application of risk management for IT-networks incorporating medical devices-Part 2-7: Application guidance-Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2014<\/td>\n116<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198344,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198343","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\/198343","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\/198344"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198343"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198343"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198343"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}