Recognized standard
81001-5-1 Edition 1.0 2021-12
FDA recognition 13-122 · IEC · Software/Informatics
Key facts
| Recognition number | 13-122 |
|---|---|
| Designation | 81001-5-1 Edition 1.0 2021-12 |
| Title | Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Software/Informatics |
| Date of entry | Dec 19, 2022 |
| Scope (excerpt) | This document defines the LIFE CYCLE requirements for development and maintenance of HEALTH SOFTWARE needed to support conformance to IEC 62443-4-1 - taking the specific needs for HEALTH SOFTWARE into account. The set of PROCESSES, ACTIVITIES, and TASKS described in this document establishes a… |
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: