| Standard | Title | Recognised by |
|---|
| AAMI RT2 | Radiation therapy readiness check | FDA |
| AAMI RT3 | Radiation therapy machine characterization | FDA |
| AAMI TIR12 | Designing, testing, and labeling medical devices intended for processing by health care faciliti | FDA |
| AAMI TIR17 | Compatibility of materials subjected to sterilization | FDA |
| AAMI TIR28 | Product adoption and process equivalence for ethylene oxide sterilization | FDA |
| AAMI NS28 | Intracranial pressure monitoring devices | FDA |
| AAMI TIR 36 | Validation of software for regulated processes | FDA |
| AAMI TIR38 | Medical device safety assurance case guidance | FDA |
| AAMI TIR41 | Active implantable medical devices - Guidance for designation of left ventricle and implantable | FDA |
| AAMI TIR42 | Evaluation of Particulates Associated with Vascular Medical Devices | FDA |
| AAMI TIR 45 | Guidance on the use of AGILE practices in the development of medical device software | FDA |
| AAMI TIR45 | Guidance on the use of AGILE practices in the development of medical device software | FDA |
| AAMI TIR 49 | Technical Information Report Design of training and instructional materials for medical devices | FDA |
| AAMI TIR57 | Principles for medical device security - Risk management. | FDA |
| AAMI TIR66 | Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable a | FDA |
| AAMI TIR69 | Technical Information Report Risk management of radio-frequency wireless coexistence for medical | FDA |
| AAMI TIR97 | Principles for medical device security - Postmarket risk management for device manufacturers | FDA |
| AAMI TIR101 | Fluid delivery performance testing for infusion pumps | FDA |
| AAMI TIR104 | Guidance on transferring health care products between radiation sterilization sources | FDA |
| AAMI TIR106 | Microbiological methods - Understanding and use of product bioburden data | FDA |
| AAMI CR515 | Cybersecurity Consideration Unique to Machine-Learning Enabled Medical Devices | FDA |
| AAMI CR34971 | Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning | FDA |