Recognized standard
TIR 80001-2-3:2012 TR 80001-2-3 Edition 1.0 2012-07
FDA recognition 13-44 · IEC · Software/Informatics
Key facts
| Recognition number | 13-44 |
|---|---|
| Designation | TIR 80001-2-3:2012 TR 80001-2-3 Edition 1.0 2012-07 |
| Title | Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Software/Informatics |
| Date of entry | Aug 6, 2013 |
| Scope (excerpt) | IEC/TR 80001-2-3:2012(E), which is a technical report, supports the Healthcare Delivery Organizations (HDO) in the risk management of medical IT-networks that incorporate one or more wireless links. The report, as part of IEC 80001, considers the use of wirelessly networked medical devices on a… |
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: