Recognized standard
TIR97:2019
FDA recognition 13-112 · AAMI · Software/Informatics
Key facts
| Recognition number | 13-112 |
|---|---|
| Designation | TIR97:2019 |
| Title | Principles for medical device security - Postmarket risk management for device manufacturers |
| Standards developer | Association for the Advancement of Medical Instrumentation |
| Specialty area | Software/Informatics |
| Date of entry | Dec 23, 2019 |
| Scope (excerpt) | This TIR provides guidance for addressing postmarket security risk management within the risk management framework defined by ANSI/AAMI/ISO 14971. While it is based on the ANSI/AAMI/ISO 14971 framework for medical device risk management, most concepts are applicable to any healthcare product that… |
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: