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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 6-321
Standard(Included in ASCA)
IEC  60601-2-52 Edition 1.0 2009-12
Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: Technical Corrigendum 1 (2010)]
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 title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MEDICAL BED and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of MEDICAL BED or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of IEC 60601-2-52 Edition 1.0 2009-12 [Rec# 6-321] will be superseded by recognition of IEC 60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION [Rec# 6-489]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-321] until July 5, 2026. After this transition period, declarations of conformity to [Rec# 6-321] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5100 Bed, Ac-Powered Adjustable Hospital Class 2 FNL
§880.5100 Bed, Therapeutic, Ac-Powered, Adjustable Home-Use Class 2 LLI
§880.5110 Bed, Hydraulic, Adjustable Hospital Class 1 FNK
§880.5120 Bed, Manual Class 1 FNJ
Relevant FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

For additional information and guidance, please visit the CDRH Web Page on Hospital Beds.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Matthew Schwerin
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.