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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 052 Date of Entry 07/15/2019 
FR Recognition Number 6-423
Standard(Included in ASCA pilot)
IEC 60601-2-6 Edition 2.1 2016-04
CONSOLIDATED VERSION Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
Scope/Abstract
IEC 60601-2-6:2012+A1:2016 specifies the minimum requirements considered to provide for a practical degree of safety in the operation of microwave therapy equipment. This particular standard amends and supplements IEC 60601-1 (third edition, 2005 and amendment 1, 2012). This second edition cancels and replaces the first edition of IEC 60601-2-6, published in 1984. This edition constitutes a technical revision and has been aligned to the third edition of IEC 60601-1:2005+A1:2012. This consolidated version consists of the second edition (2012) and its amendment 1 (2016).
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
§878.4400 System, Ablation, Microwave And Accessories Class 2 NEY
Relevant FDA Guidance and/or Supportive Publications*
1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

2. Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff, Issued August 2016.
FDA Technical Contact
 David Talley
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVA/
  301-796-4861
  David.Talley@fda.hhs.gov
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.
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