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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Recognition 08/21/2017 
FR Recognition Number 6-390
Standard
IEC 80601-2-35 Edition 2.1 2016-04
CONSOLIDATED VERSION Medical electrical equipment-Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use [Including: Amendment 1 (2016)]
Scope/Abstract
IEC 80601-2-35:2009 establishes particular basic safety and essential performance requirements, which minimize hazards to patients, and operators for heating devices using blankets, pads or mattresses and intended for heating in medical use and specifies tests for demonstrating compliance with these requirements. This second edition cancels and replaces the first edition published in 1996. This edition constitutes a technical revision. This new edition provides consistency with the third edition of IEC 60601-1, as well as with the four other particular standards related to paediatric equipment for which the committee is responsible.
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
Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment. Issued March 2006
FDA Technical Contacts
 Crystal Lewis
  FDA/OMPT/CDRH/OC/DMQ/R/ENT/GH-ODB/
  301-796-6116
  Crystal.Lewis@fda.hhs.gov
 Carolyn Dorgan
  FDA/OMPT/CDRH/ODE
  240-402-1656
  Carolyn.Dorgan@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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