Recognized standard
TIR 80001-2-6:2014
FDA recognition 13-82 · ANSI · Software/Informatics
Key facts
| Recognition number | 13-82 |
|---|---|
| Designation | TIR 80001-2-6:2014 |
| Title | Application of risk management for IT networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements |
| Standards developer | American National Standards Institute |
| Specialty area | Software/Informatics |
| Date of entry | Jun 27, 2016 |
| Scope (excerpt) | ISO/TR 80001-2-6:2014 provides guidance on implementing RESPONSIBILITY AGREEMENTS, which are described in IEC 80001-1 as used to establish the roles and responsibilities among the stakeholders engaged in the incorporation of a MEDICAL DEVICE into an IT-NETWORK in order to support compliance to IEC… |
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: