Recognized standard
TR 80001-2-8 Edition 1.0 2016-05
FDA recognition 13-102 · IEC · Software/Informatics
Key facts
| Recognition number | 13-102 |
|---|---|
| Designation | TR 80001-2-8 Edition 1.0 2016-05 |
| Title | Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2 |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Software/Informatics |
| Date of entry | Dec 4, 2017 |
| Scope (excerpt) | This part of IEC 80001, which is a Technical Report, provides guidance to Health Delivery Organizations (HDOs) and medical device manufacturers (MDMs) for the application of the framework outlined in IEC TR 80001-2-2. Managing the risk in connecting medical devices to IT-networks requires the… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
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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: