| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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060
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Date of Entry 05/29/2023
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FR Recognition Number
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6-489
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| Standard | (Included in ASCA) |
IEC 60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION
Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
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Scope/AbstractThis 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 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.
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| Extent of Recognition
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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. |
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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| FDA recognition of IEC 60601-2-52 Edition 1.0 2009-12 [Rec# 6-321] will be superseded by recognition of IEC 60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION [Rec# 6-489].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. |
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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
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| §880.5100 |
Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
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Class 2
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LLI
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| §880.5110 |
Bed, Hydraulic, Adjustable Hospital
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Class 1
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FNK
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| §880.5120 |
Bed, Manual
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Class 1
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FNJ
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Relevant FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.
CDRH Web Page on Hospital Beds: https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/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. |
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| FDA Technical Contacts
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| Standards Development Organization
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FDA Specialty Task Group (STG)
| General Plastic Surgery/General Hospital |
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| *These are provided as examples and others may be applicable. |
