{"id":198273,"date":"2024-10-19T12:37:19","date_gmt":"2024-10-19T12:37:19","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir69-2017\/"},"modified":"2024-10-25T05:10:26","modified_gmt":"2024-10-25T05:10:26","slug":"aami-tir69-2017","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir69-2017\/","title":{"rendered":"AAMI TIR69 2017"},"content":{"rendered":"

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.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nAAMI TIR69:2017; Risk management of radio-frequency wireless coexistence for medical devices and systems <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Technical Information Report <\/td>\n<\/tr>\n
5<\/td>\nCopyright information
Contents <\/td>\n<\/tr>\n
6<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
7<\/td>\nCommittee representation <\/td>\n<\/tr>\n
9<\/td>\nForeword <\/td>\n<\/tr>\n
10<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\n1. General
1.1 Purpose and intent
1.2 Scope <\/td>\n<\/tr>\n
12<\/td>\n1.3 Intended audience <\/td>\n<\/tr>\n
13<\/td>\n2. Reference standards and documents <\/td>\n<\/tr>\n
14<\/td>\n3. Definitions <\/td>\n<\/tr>\n
16<\/td>\n4. Risk management
4.1 Overview
4.2 Risk management of medical device wireless functions
4.2.1 Overview <\/td>\n<\/tr>\n
17<\/td>\n4.2.2 Alignment with relevant standards
4.2.3 Quality of Service <\/td>\n<\/tr>\n
18<\/td>\n4.3 Risk categories <\/td>\n<\/tr>\n
20<\/td>\n5. Overview of process <\/td>\n<\/tr>\n
21<\/td>\nFigure 2 – Process flowchart for this TIR <\/td>\n<\/tr>\n
22<\/td>\n6. 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 <\/td>\n<\/tr>\n
23<\/td>\n6.3.3 Wireless medical device density
6.3.4 Wireless security
6.4 Wireless function description
6.5 Wireless function performance threshold and metric <\/td>\n<\/tr>\n
24<\/td>\n6.6 Wireless function performance monitoring
6.7 Testing tiers
6.8 Intended signal
6.9 Test setup
6.10 Test configurations <\/td>\n<\/tr>\n
25<\/td>\n6.11 Electromagnetic intended use environment and other RF wireless technology
6.12 Unintended signals <\/td>\n<\/tr>\n
27<\/td>\n7. 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 <\/td>\n<\/tr>\n
28<\/td>\nFigure 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 <\/td>\n<\/tr>\n
29<\/td>\n7.4 Baseline the performance of the unintended signals
7.5 Test the wireless functions of the DUT <\/td>\n<\/tr>\n
30<\/td>\n8. 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 <\/td>\n<\/tr>\n
32<\/td>\n9. Summary report and documentation <\/td>\n<\/tr>\n
33<\/td>\nAnnex A: Glossary of additional terms <\/td>\n<\/tr>\n
35<\/td>\nAnnex B: Report template <\/td>\n<\/tr>\n
37<\/td>\nExecutive Summary
Overview
Experimental Results <\/td>\n<\/tr>\n
38<\/td>\nSection 1: Medical Device Overview <\/td>\n<\/tr>\n
39<\/td>\nSection 2: Test Procedures and Experimental Results <\/td>\n<\/tr>\n
40<\/td>\nTable B2 – Test summary table (with example information) <\/td>\n<\/tr>\n
41<\/td>\nSection 3: Post-Test Analysis
Table B3 – Example Risk Analysis Table <\/td>\n<\/tr>\n
42<\/td>\nAnnex C: Example of wireless test report for a minor risk device
Executive Summary
Overview
Experimental Results <\/td>\n<\/tr>\n
43<\/td>\nSection 1: Medical Device Overview <\/td>\n<\/tr>\n
45<\/td>\nSection 2: Test Procedures and Experimental Results
Figure C2: Smart Phone under test. <\/td>\n<\/tr>\n
46<\/td>\nTable C2 – Test Summary Table <\/td>\n<\/tr>\n
47<\/td>\nAnnex D: Example of wireless test report for a major risk device
Executive Summary
Overview
Experimental Results <\/td>\n<\/tr>\n
48<\/td>\nSection 1: Medical Device Overview <\/td>\n<\/tr>\n
51<\/td>\nSection 2: Test Procedures and Experimental Results
Figure D1: System Rx #2 under test <\/td>\n<\/tr>\n
52<\/td>\nFigure D2: System tx under test <\/td>\n<\/tr>\n
53<\/td>\nTable D2 – Test Summary Table <\/td>\n<\/tr>\n
54<\/td>\nAnnex E: Wireless functions and risk categories
Table E1 \u2013 Clinical Priority
Table E2 – Wireless Function Example, Clinical Priority, and Risk Category <\/td>\n<\/tr>\n
56<\/td>\nAnnex F: Intended use environments <\/td>\n<\/tr>\n
57<\/td>\nAnnex G: Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI TIR69:2017 – Risk management of radio-frequency wireless coexistence for medical devices and systems<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2017<\/td>\n61<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198277,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198273","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\/198273","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\/198277"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198273"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198273"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198273"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}