Recognized standard
TIR 49:2013/(R)2020
FDA recognition 5-84 · AAMI · General I (QS/RM)
Key facts
| Recognition number | 5-84 |
|---|---|
| Designation | TIR 49:2013/(R)2020 |
| Title | Technical Information Report Design of training and instructional materials for medical devices used in non-clinical environments |
| Standards developer | Association for the Advancement of Medical Instrumentation |
| Specialty area | General I (QS/RM) |
| Date of entry | Jan 30, 2014 |
| Scope (excerpt) | The purpose of this technical information report (TIR) is to provide a relevant source of information, design criteria, and guidelines for the instructional and training materials and processes intended to accompany medical devices used in a non-clinical environment, which for the purpose of this… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: