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AAMI TIR80001 2 7 2014

AAMI TIR80001 2 7 2014

$162.84

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

Published By Publication Date Number of Pages
AAMI 2014 116
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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

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PDF Pages PDF Title
1 ANSI/AAMI/IEC TIR80001-2-7:2014, Application of risk management for IT-networks incorporating medical โ€” Application guidance โ€” Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
3 Title page
4 Copyright information
5 AAMI Technical Information Report
ANSI Technical Report
6 Contents
7 Glossary of equivalent standards
8 Committee representation
9 Background of AAMI adoption of ISO TR 80001-2-7 Ed.1
10 Foreword
11 Introduction
13 1 Scope
2 Normative References
3 Terms and Definitions
14 4 Assessment Method
4.1 Prerequisites
4.2 Assessment Method Overview
Figure 1 โ€” PAM Processes โ€“ Assessment Method
4.3 Assessment Stages
15 4.3.1 Stage 1 โ€“ Defining Assessment Scope
4.3.2 Stage 2 โ€“ Stakeholder Involvement
4.3.3 Stage 3 โ€“ Information Collection and Evaluation
4.3.4 Stage 4 โ€“ Findings Report
4.3.5 Stage 5 โ€“ Presentation of Findings
16 4.3.6 Stage 6 โ€“ Improvement Plan (optional)
4.3.7 Stage 7- Follow-up Assessment (optional)
4.4 Process Attribute Rating Scale
17 4.5 Capability Levels
4.6 Tailoring the Assessment Method
18 Annex A: Assessment Method
A.1 Exemplar assessment questions
A.1.1 Introduction
19 A.1.2 MRM.1 Medical IT-Network Risk Management Process
Table A.1 โ€” MRM.1 BP1
20 Table A.2 โ€” MRM.1 BP2
Table A.3 โ€” MRM.1 BP3
21 Table A.4 โ€” MRM.1 BP4
Table A.5 โ€” MRM.1 BP5
22 Table A.6 โ€” MRM.1 BP6
23 A.1.3 MRM 1.1 Risk Analysis & Evaluation Process
Table A.7 โ€” MRM1.1 BP1
24 Table A.8 โ€” MRM1.1 BP2
Table A.9 โ€” MRM1.1 BP3
Table A.10 โ€” MRM1.1 BP4
25 A.1.4 MRM 1.2 Risk Control Process
Table A.11 โ€” MRM1.2 BP1
Table A.12 โ€” MRM1.2 BP2
26 Table A.13 โ€” MRM1.2 BP3
Table A.14 โ€” MRM1.2 BP4
27 Table A.15 โ€” MRM1.2 BP5
Table A.16 โ€” MRM1.2 BP6
28 Table A.17 โ€” MRM1.2 BP7
A.1.5 MRM 1.3 Residual Risk Process
Table A.18 โ€” MRM1.3 BP1
29 Table A.19 โ€” MRM1.3 BP2
Table A.20 โ€” MRM1.3 BP3
Table A.21 โ€” MRM1.3 BP4
Table A.22 โ€” MRM1.3 BP5
30 Table A.23 โ€” MRM1.3 BP6
A.1.6 CRCM.1 Change Release & Configuration Management Process
Table A.24 โ€” CRCM.1 BP1
Table A.25 โ€” CRCM.1 BP2
31 Table A.26 โ€” CRCM.1 BP3
Table A.27 โ€” CRCM.1 BP4
Table A.28 โ€” CRCM.1 BP5
32 CRCM.2 Decision on how to apply Risk Management Process
Table A.29 โ€” CRCM.2 BP1
Table A.30 โ€” CRCM.2 BP2
Table A.31 โ€” CRCM.2 BP3
Table A.32 โ€” CRCM.2 BP4
33 Table A.33 โ€” CRCM.2 BP5
Table A.34 โ€” CRCM.2 BP6
34 Table A.35 โ€” CRCM.2 BP7
35 Table A.36 โ€” CRCM.2 BP8
Table A.37 โ€” CRCM.2 BP9
A.1.6 CRCM.3 Go Live Process
Table A.38 โ€” CRCM.3 BP1
Table A.39 โ€” CRCM.3 BP2
Table A.40 โ€” CRCM.3 BP3
36 A.1.7 LNRM.1 Monitoring Process
Table A.41 โ€” LNRM.1 BP1
Table A.42 โ€” LNRM.1 BP2
Table A.43 โ€” LNRM.1 BP3
37 A.1.8 LNRM.2 Event Management Process
Table A.44 โ€” LNRM.2 BP.1
Table A.45 โ€” LNRM.2 BP.2
Table A.46 โ€” LNRM.2 BP.3
Table A.47 โ€” LNRM.2 BP.4
Table A.48 โ€” LNRM.2 BP.5
38 A.1.9 MDP.1 Medical IT-Network Planning Process
Table A.49 โ€” MDP.1 BP.1
Table A.50 โ€” MDP.1 BP.2
39 Table A.51 โ€” MDP.1 BP.3
Table A.52 โ€” MDP.1 BP.4
Table A.53 โ€” MDP.1 BP.5
Table A.54 โ€” MDP.1 BP.6
40 Table A.55 โ€” MDP.1 BP.7
A.1.10 MDP.2 Medical IT-Network Documentation Process
Table A.56 (1 of 2) โ€” MDP.2 BP.1
41 Table A.56 (2 of 2) โ€“ MDP.2 BP.1
Table A.57 โ€” MDP.2 BP.2
42 Table A.58 โ€” MDP.2 BP.3
43 A.1.11 MDP.3 Responsibility Agreements Process
Table A.59 โ€” MDP.3 BP.1
44 Table A.60 โ€” MDP.3 BP.2
45 Table A.61 โ€” MDP.3 BP.3
A.1.12 MDP.4 Risk Management Policy Process
Table A.62 โ€” MDP.4 BP.1
Table A.63 โ€” MDP.4 BP.2
46 Table A.64 โ€” MDP.4 BP.2
Table A.65 โ€” MDP.4 BP.4
47 A.1.13 MDP.5 Organisational Risk Management Process
Table A.66 โ€” MDP.5 BP.1
Table A.67 โ€” MDP.5 BP.2
48 Table A.68 โ€” MDP.5 BP.3
Table A.69 โ€” MDP.5 BP.4
49 A.2 Exemplar Assessment Documentation:
A.2.1 Introduction
A.2.2 Assessment Details
Table A.70 โ€” Assessment Details Template
50 A.2.3 Assessment Interview Template
Table A.71 โ€” Assessment Interview Template
A.2.4 Findings Report
Table A.72 โ€” Findings Report Template
51 Annex B: Process Reference Model
B.1 Introduction
B.2 Overview of the Process Reference Model
B.2.1 General
52 Figure B.1 โ€” Processes in the Process Reference Model
B.2.2 Process Descriptions
53 B.3 Process Descriptions
B.3.1 MRM.1 Medical IT-Network Risk Management Process
54 B.3.2 MRM.1.1 Risk Analysis & Evaluation Process
55 B.3.3 MRM.1.2 Risk Control Process
56 B.3.4 MRM.1.3 Residual Risk Process
57 B.3.5 CRCM.1 Change Release & Configuration Management Process
B.3.6 CRCM.2 Decision on how to apply Risk Management Process
58 B.3.7 CRCM.3 Go Live Process
B.3.8 LNRM.1 Monitoring Process
59 B.3.9 LNRM.2 Event Management Process
B.3.10 MDP.1 Medical IT-Network Planning Process
60 B.3.11 MDP.2 Medical IT-Network Documentation Process
61 B.3.12 MDP.3 Responsibility Agreements Process
B.3.13 MDP.4 Risk Management Policy Process
62 B.3.14 MDP.5 Organisational Risk Management Process
63 B.4 PRM Conformity to ISO/IEC 15504-2
B.4.1 General
B.4.2 Requirements for Process Reference Models
64 B.4.3 Process descriptions
65 Annex C: Process Assessment Model
C.1 Introduction
Figure C.1 โ€” Relationship to IEC 80001-1, IEC 80001-1(PRM) and ISO/IEC 15504-2
66 C.2 Overview of the exemplar Process Assessment Model
C.2.1 Introduction to Overview
Figure C.2 โ€” Relationship between the Process Assessment Model and its inputs
67 C.2.2 Structure of the exemplar Process Assessment Model
C.2.2.1 Processes
Figure C.3 โ€” Processes in the Process Reference Model
C.2.2.2 Process dimension
C.2.2.3 Capability dimension
68 Table C.1 โ€” Capability levels and process attributes
C.3 Assessment Indicators
C.3.1 Overview
69 Figure C.4 โ€” Assessment Indicators
70 C.3.2 Process Capability Indicators
Figure C.5 โ€” Process capability indicators
71 C.3.3 Process Performance Indicators
C.4 Measuring process capability
72 Figure C.6 โ€” Relationship between assessment indicators and process capability
C.5 The process dimension and process performance indicators (Level 1)
C.5.1 General
73 C.5.2 Medical IT-Network Risk Management Process
C.5.3 Risk Analysis & Evaluation Process
74 C.5.4 Risk Control Process
75 C.5.5 Residual Risk Process
76 C.5.6 Change Release & Configuration Management Process
77 C.5.7 Decision on how to apply Risk Management Process
78 C.5.8 Go Live Process
C.5.9 Monitoring Process
79 C.5.10 Event Management Process
C.5.11 Medical IT-Network Planning Process
80 C.5.12 Medical IT-Network Documentation Process
81 C.5.13 Responsibility Agreements Process
82 C.5.14 Risk Management Policy Process
C.5.15 Organisational Risk Management Process
83 C.6 Process capability indicators (Level 1 to 5)
99 C.7 Conformity of the exemplar Process Assessment Model
C.7.1 General
C.7.2 Introduction
100 C.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
102 C.7.6 Expression of assessment results
C.8 Work Product characteristics
C.8.1 General
103 Table C.3 โ€” Input/Output identificatioTable C.3 โ€” Input/Output identificatio
C.8.2 Generic Work Products
C.8.3 Specific inputs and outputs
115 Annex D: Abbreviations and Process Identifiers
D.1 Abbreviations:
D.2 Process Group
D.3 Process IDs
116 Bibliography

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$162.84