Recognized standard
2700-1:2019
FDA recognition 13-120 · ANSI · Software/Informatics
Key facts
| Recognition number | 13-120 |
|---|---|
| Designation | 2700-1:2019 |
| Title | Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model |
| Standards developer | American National Standards Institute |
| Specialty area | Software/Informatics |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard specifies general requirements, a model and framework for integrating equipment to create a INTEGRATED CLINICAL ENVIRONMENT (ICE), as defined in 3.6. This standard specifies the characteristics necessary for the safe integration of MEDICAL DEVICES and other equipment, via an electronic… |
At a glance
- 1–9 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: