Recognized standard
TIR 80001-2-2:2012 TR 80001-2-2 Edition 1.0 2012-07
FDA recognition 13-42 · IEC · Software/Informatics
Key facts
| Recognition number | 13-42 |
|---|---|
| Designation | TIR 80001-2-2:2012 TR 80001-2-2 Edition 1.0 2012-07 |
| Title | Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Software/Informatics |
| Date of entry | Aug 6, 2013 |
| Scope (excerpt) | This part of IEC 80001 creates a framework for the disclosure of security-related capabilities and risks necessary for managing the risk in connecting medical devices to IT-networks and for the security dialog that surrounds the IEC 80001-1 risk management of IT-network connection. This security… |
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: