Recognized standard
2700-2-1:2022
FDA recognition 13-130 · ANSI · Software/Informatics
Key facts
| Recognition number | 13-130 |
|---|---|
| Designation | 2700-2-1:2022 |
| Title | Medical devices and medical systems - Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging |
| Standards developer | American National Standards Institute |
| Specialty area | Software/Informatics |
| Date of entry | Oct 9, 2023 |
| Scope (excerpt) | This document provides general functional, performance, security, and interoperability requirements of ICE data logging systems including the recording and storage of data in support of forensic analysis of ICE systems. DATA LOGs, data logging, and data loggers can play an important role in… |
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: