Recognized standard
80001-1 Edition 1.0 2010-10 80001-1:2010
FDA recognition 13-38 · IEC · Software/Informatics
Key facts
| Recognition number | 13-38 |
|---|---|
| Designation | 80001-1 Edition 1.0 2010-10 80001-1:2010 |
| Title | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Software/Informatics |
| Date of entry | Aug 6, 2013 |
| Scope (excerpt) | Recognizing that medical devices are incorporated into IT-networks to achieve desirable benefits (for example, interoperability), this international standard defines the roles, responsibilities and activities that are necessary for risk management of IT-networks incorporating medical devices to… |
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: