AAMI TIR75 2019
$115.49
AAMI TIR75:2019 – Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
| Published By | Publication Date | Number of Pages |
| AAMI | 2019 | 37 |
Guidance on factors that manufacturers should consider when designing, testing, and monitoring interoperable medical devices.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI TIR75:2019; Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples |
| 3 | Title page |
| 4 | AAMI Technical Information Report Copyright information |
| 5 | Contents Page |
| 6 | Committee representation |
| 8 | Foreword |
| 9 | Introduction |
| 11 | 1 Scope 1.1 General 1.2 Exclusions 2 References 3 Factors to consider |
| 12 | 3.1 Context of use |
| 13 | 3.1.1 Use environment 3.1.1.1 Communication networks and capabilities 3.1.2 Foreseeable misuse and off label use |
| 14 | 3.1.3 Human factors 3.1.4 Labeling 3.2 Device properties |
| 15 | 3.2.1 Device configuration 3.2.2 Device state |
| 16 | 3.2.3 Device security 3.2.4 Device maintenance and software updates |
| 17 | 3.3 Network-Related (technical) properties 3.3.1 Interoperability context of use 3.3.2 Timeliness |
| 19 | Annex A Controls—Example 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) |
| 20 | A.3 Example: Patient controlled analgesia (PCA) |
| 21 | Annex B Alarms—Example analysis B.1 Remote alarm notifications (replacement) to nurses’ station/mobile platform |
| 22 | B.2 Remote alarm notifications (redundant) to nurses’ station/mobile platform |
| 23 | B.3 Smart alarm maintenance (decision tool within the system with rule system for combining alarms to give a specific outcome assessment) |
| 25 | Annex C Data transfer—Example analysis C.1 ECG monitor sending data to EMR |
| 26 | 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) |
| 28 | Annex D Remote viewing—Example analysis D.1 Evaluation of static image meant for diagnosis on smartphone or tablet |
| 29 | D.2 Anesthesiologist is viewing physiological real-time data from several cases simultaneously (could be on a mobile device) |
| 30 | Annex E Maintenance activities—Example analysis E.1 Wireless asset tracking |
| 31 | E.2 Remote Software Update |
| 32 | Annex F Special considerations: Software only devices, clouds, HIT, Wi-Fi |
| 34 | Annex G Special considerations: Mobile devices |
| 35 | Annex H Special considerations: Distributed platforms, computation, and information |
