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Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 6-308: IEC 80601-2-35 Edition 2.0 2009-10, 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: technical corrigendum 1 (2012)]. (General Plastic Surgery/General Hospital)

Date of Standard: 2009. 
Address of Standards Development Organization:
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
  SWITZERLAND
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF COMPLIANCE (OC)
(3)OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB)
Devices Affected:
All mattresses, heating blankets or pads for use with standard hospital beds for medical use
Processes Affected:
510(k), PMA, IDE, PreIDE, HDE, GMP, Design Controls
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
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 Guidance:
FDA Guidance to Reduce Patient Entrapment would be replaced when this standard's transition period ends. (Note: Test methods for entrapment are not written for the layperson in the IEC standard)
FDA Technical Contact:
 Gail Gantt
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2524
  Silver Spring MD 20993
  301/796-6288
  email: gail.gantt@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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