Recognized standard
TIR80001-2-5:2014 TR 80001-2-5 Edition 1.0 2014-12
FDA recognition 13-70 · IEC · Software/Informatics
Key facts
| Recognition number | 13-70 |
|---|---|
| Designation | TIR80001-2-5:2014 TR 80001-2-5 Edition 1.0 2014-12 |
| Title | Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Software/Informatics |
| Date of entry | Jan 27, 2015 |
| Scope (excerpt) | IEC TR 80001-2-5:2014(E) which is a technical report, gives guidance and practical techniques for responsible organizations, medical device manufacturers and providers of other information technology in the application of IEC 80001-1:2010 for the risk management of distributed alarm systems. 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: