Recognized standard
HA60601-1-11:2015 [Including AMD1:2021]
FDA recognition 19-47 · ANSI · General II (ES/EMC)
Key facts
| Recognition number | 19-47 |
|---|---|
| Designation | HA60601-1-11:2015 [Including AMD1:2021] |
| Title | Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC… |
| Standards developer | American National Standards Institute |
| Specialty area | General II (ES/EMC) |
| Date of entry | May 30, 2022 |
| Scope (excerpt) | This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME HEALTHCARE ENVIRONMENT, as defined in 3.1, and specified by the MANUFACTURER in the instructions for use. This International Standard… |
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: