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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Recognition 01/30/2014 
FR Recognition Number 6-321
Standard
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)]
Scope/Abstract
IEC 60601-2-52:2009+A1:2015 applies to the basic safety and essential performance of medical beds intended for adults. IEC 60601-2-52:2009 is the realization of much work in alignment, and scope adjustment between IEC 60601-2-38, EN 1970, and the third edition of IEC 60601-1. This consolidated version consists of the first edition (2009) and its amendment 1 (2015). Therefore, no need to order amendment in addition to this publication.
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.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§880.5120 Bed, Manual Class 1 FNJ
§880.5110 Bed, Hydraulic, Adjustable Hospital Class 1 FNK
§880.5100 Bed, Ac-Powered Adjustable Hospital Class 2 FNL
§880.5100 Bed, Therapeutic, Ac-Powered, Adjustable Home-Use Class 2 LLI
Relevant FDA Guidance and/or Supportive Publications
FDA Guidance to Reduce Patient Entrapment would be replaced when this standard's transition period ends.
FDA Technical Contacts
 Joan Todd
  FDA/OMPT/CDER/OND/OHOP/
  301-796-6079
  joan.todd@fda.hhs.gov
 Matthew Schwerin
  FDA/OMPT/CDRH/OSEL/DAM/
  301-563-9114
  matthew.schwerin@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
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