Recognized standard
60601-2-52 Edition 1.0 2009-12
FDA recognition 6-321 · IEC · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-321 |
|---|---|
| Designation | 60601-2-52 Edition 1.0 2009-12 |
| Title | Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: Technical Corrigendum 1 (2010)] |
| Standards developer | International Electrotechnical Commission |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Jan 30, 2014 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS intended for adults, hereafter referred to as MEDICAL BED as defined in 201.3.212. If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to ME SYSTEMS only, the… |
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: