Recognized standard
TIR 80001-2-1 2012 TR 80001-2-1 Edition 1.0 2012-07
FDA recognition 13-40 · IEC · Software/Informatics
Key facts
| Recognition number | 13-40 |
|---|---|
| Designation | TIR 80001-2-1 2012 TR 80001-2-1 Edition 1.0 2012-07 |
| Title | Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks; Practical applications and examples Application of risk management for IT- networks incorporating medical devices - Part 2-1: Step-by-step risk management of… |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Software/Informatics |
| Date of entry | Aug 6, 2013 |
| Scope (excerpt) | This technical report provides step-by-step information to aid responsible organizations in implementation of the risk management process required by IEC 80001-1. Specifically, it details the steps involved in executing subclause 4.4 of IEC 80001-1:2010 and provides guidance in the form of a study… |
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: