Recognized standard
TR 80001-2-9 Edition 1.0 2017-01
FDA recognition 13-103 · IEC · Software/Informatics
Key facts
| Recognition number | 13-103 |
|---|---|
| Designation | TR 80001-2-9 Edition 1.0 2017-01 |
| Title | Application of risk management for it-networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Software/Informatics |
| Date of entry | Dec 4, 2017 |
| Scope (excerpt) | IEC TR 80001-2-9:2017(E) establishes a security case framework and provides guidance to health care delivery organizations (HDO) and medical device manufacturers (MDM) for identifying, developing, interpreting, updating and maintaining security cases for networked medical devices. Use of this part… |
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: