{"id":198153,"date":"2024-10-19T12:36:51","date_gmt":"2024-10-19T12:36:51","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir75-2019\/"},"modified":"2024-10-25T05:10:04","modified_gmt":"2024-10-25T05:10:04","slug":"aami-tir75-2019","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir75-2019\/","title":{"rendered":"AAMI TIR75 2019"},"content":{"rendered":"
Guidance on factors that manufacturers should consider when designing, testing, and monitoring interoperable medical devices.<\/p>\n
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
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1<\/td>\n | AAMI TIR75:2019; Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples <\/td>\n<\/tr>\n | ||||||
3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
4<\/td>\n | AAMI Technical Information Report Copyright information <\/td>\n<\/tr>\n | ||||||
5<\/td>\n | Contents Page <\/td>\n<\/tr>\n | ||||||
6<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
8<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
9<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
11<\/td>\n | 1 Scope 1.1 General 1.2 Exclusions 2 References 3 Factors to consider <\/td>\n<\/tr>\n | ||||||
12<\/td>\n | 3.1 Context of use <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | 3.1.1 Use environment 3.1.1.1 Communication networks and capabilities 3.1.2 Foreseeable misuse and off label use <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | 3.1.3 Human factors 3.1.4 Labeling 3.2 Device properties <\/td>\n<\/tr>\n | ||||||
15<\/td>\n | 3.2.1 Device configuration 3.2.2 Device state <\/td>\n<\/tr>\n | ||||||
16<\/td>\n | 3.2.3 Device security 3.2.4 Device maintenance and software updates <\/td>\n<\/tr>\n | ||||||
17<\/td>\n | 3.3 Network-Related (technical) properties 3.3.1 Interoperability context of use 3.3.2 Timeliness <\/td>\n<\/tr>\n | ||||||
19<\/td>\n | Annex A Controls\u2014Example analysis A.1 Synchronizing an imaging device and a ventilator A.2 Proximal teleoperation (human-controlled remote control) of a device (core functionality\/safety-critical) <\/td>\n<\/tr>\n | ||||||
20<\/td>\n | A.3 Example: Patient controlled analgesia (PCA) <\/td>\n<\/tr>\n | ||||||
21<\/td>\n | Annex B Alarms\u2014Example analysis B.1 Remote alarm notifications (replacement) to nurses\u2019 station\/mobile platform <\/td>\n<\/tr>\n | ||||||
22<\/td>\n | B.2 Remote alarm notifications (redundant) to nurses\u2019 station\/mobile platform <\/td>\n<\/tr>\n | ||||||
23<\/td>\n | B.3 Smart alarm maintenance (decision tool within the system with rule system for combining alarms to give a specific outcome assessment) <\/td>\n<\/tr>\n | ||||||
25<\/td>\n | Annex C Data transfer\u2014Example analysis C.1 ECG monitor sending data to EMR <\/td>\n<\/tr>\n | ||||||
26<\/td>\n | C.2 Timing and volume of data transfer C.3 Adding a data category to be transmitted (already transmitting some data, this is new type of data) <\/td>\n<\/tr>\n | ||||||
28<\/td>\n | Annex D Remote viewing\u2014Example analysis D.1 Evaluation of static image meant for diagnosis on smartphone or tablet <\/td>\n<\/tr>\n | ||||||
29<\/td>\n | D.2 Anesthesiologist is viewing physiological real-time data from several cases simultaneously (could be on a mobile device) <\/td>\n<\/tr>\n | ||||||
30<\/td>\n | Annex E Maintenance activities\u2014Example analysis E.1 Wireless asset tracking <\/td>\n<\/tr>\n | ||||||
31<\/td>\n | E.2 Remote Software Update <\/td>\n<\/tr>\n | ||||||
32<\/td>\n | Annex F Special considerations: Software only devices, clouds, HIT, Wi-Fi <\/td>\n<\/tr>\n | ||||||
34<\/td>\n | Annex G Special considerations: Mobile devices <\/td>\n<\/tr>\n | ||||||
35<\/td>\n | Annex H Special considerations: Distributed platforms, computation, and information <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" AAMI TIR75:2019 – Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples<\/b><\/p>\n |