AAMI TIR69 2017

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AAMI TIR69:2017 – Risk management of radio-frequency wireless coexistence for medical devices and systems

Published By	Publication Date	Number of Pages
AAMI	2017	61

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This Technical Information Report (TIR) provides a process and guidance on performing a radiofrequency (RF) wireless coexistence evaluation of a medical device as part of an overall medical device risk management approach. The process includes pre-testing activities to gather information needed to determine the tier at which to perform testing, the testing and report, and post-test analysis. The TIR also provides sample reports and additional information to aid in documenting the medical device wireless coexistence evaluation and integration into risk assessment and management.

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PDF Pages	PDF Title
1	AAMI TIR69:2017; Risk management of radio-frequency wireless coexistence for medical devices and systems
3	Title page
4	AAMI Technical Information Report
5	Copyright information Contents
6	Glossary of equivalent standards
7	Committee representation
9	Foreword
10	Introduction
11	1. General 1.1 Purpose and intent 1.2 Scope
12	1.3 Intended audience
13	2. Reference standards and documents
14	3. Definitions
16	4. Risk management 4.1 Overview 4.2 Risk management of medical device wireless functions 4.2.1 Overview
17	4.2.2 Alignment with relevant standards 4.2.3 Quality of Service
18	4.3 Risk categories
20	5. Overview of process
21	Figure 2 – Process flowchart for this TIR
22	6. Pre-test preparation 6.1 Overview 6.2 Functional description of the medical device under test 6.3 RF wireless technology specifications 6.3.1 Overview 6.3.2 Wireless network connections
23	6.3.3 Wireless medical device density 6.3.4 Wireless security 6.4 Wireless function description 6.5 Wireless function performance threshold and metric
24	6.6 Wireless function performance monitoring 6.7 Testing tiers 6.8 Intended signal 6.9 Test setup 6.10 Test configurations
25	6.11 Electromagnetic intended use environment and other RF wireless technology 6.12 Unintended signals
27	7. Wireless coexistence test methodology 7.1 Overview 7.2 Test environment and setup 7.2.1 Overview Figure 3 – Conducted test setup with 20dB attenuation
28	Figure 4 – Setup for the radiated method 7.2.2 Ambient noise level 7.2.3 RF propagation channel 7.3 Baseline the wireless functions of the DUT in the test environment
29	7.4 Baseline the performance of the unintended signals 7.5 Test the wireless functions of the DUT
30	8. Post-test analysis 8.1 Overview 8.2 Review test results 8.2.1 Overview 8.2.2 Test result assessment prior to product approval by manufacturer 8.2.3 Post-market testing and assessment
32	9. Summary report and documentation
33	Annex A: Glossary of additional terms
35	Annex B: Report template
37	Executive Summary Overview Experimental Results
38	Section 1: Medical Device Overview
39	Section 2: Test Procedures and Experimental Results
40	Table B2 – Test summary table (with example information)
41	Section 3: Post-Test Analysis Table B3 – Example Risk Analysis Table
42	Annex C: Example of wireless test report for a minor risk device Executive Summary Overview Experimental Results
43	Section 1: Medical Device Overview
45	Section 2: Test Procedures and Experimental Results Figure C2: Smart Phone under test.
46	Table C2 – Test Summary Table
47	Annex D: Example of wireless test report for a major risk device Executive Summary Overview Experimental Results
48	Section 1: Medical Device Overview
51	Section 2: Test Procedures and Experimental Results Figure D1: System Rx #2 under test
52	Figure D2: System tx under test
53	Table D2 – Test Summary Table
54	Annex E: Wireless functions and risk categories Table E1 – Clinical Priority Table E2 – Wireless Function Example, Clinical Priority, and Risk Category
56	Annex F: Intended use environments
57	Annex G: Bibliography


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Standard Title	AAMI TIR69:2017 – Risk management of radio-frequency wireless coexistence for medical devices and systems
Published Code	AAMI
Publication Date	2017
Pages Count	61

AAMI TIR69 2017

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