Recognized standard
60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION
FDA recognition 6-489 · IEC · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-489 |
|---|---|
| Designation | 60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION |
| Title | Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds |
| Standards developer | International Electrotechnical Commission |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | May 29, 2023 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS as defined in 201.3.212, intended for ADULTS, as defined in 201.3.219. If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to ME SYSTEMS only, the title and… |
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: