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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 049 Date of Entry 06/07/2018 
FR Recognition Number 12-311
Standard(Included in ASCA)
IEC  60601-2-65 Edition 1.1 2017-05 CONSOLIDATED VERSION
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment
Scope/Abstract
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of DENTAL INTRA-ORAL X-RAY EQUIPMENT and its main components, hereafter also called ME EQUIPMENT.

The scope of this standard is restricted to X-RAY EQUIPMENT where the X-RAY TUBE ASSEMBLY contains the HIGH-VOLTAGE TRANSFORMER ASSEMBLY.

DENTAL EXTRA-ORAL X-RAY EQUIPMENT is excluded from the scope of this standard

ME EQUIPMENT and ME SYSTEMS in the scope of IEC 60601-2-63, IEC 60601-2-44, IEC 60601-2-54, IEC 60601-2-45 or IEC 60601-2-43 are excluded from the scope of this particular standard. The scope of this International Standard also excludes RADIOTHERAPY SIMULATORS and equipment for bone or tissue absorption densitometry. Excluded from the scope is also ME EQUIPMENT intended to be used for DENTAL RADIOSCOPY.
Within its specific scope, the clauses of this particular standard supersede and replace those of IEC 60601-2-7, Medical electrical equipment - Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators and of IEC 60601-2-32, Medical electrical equipment - Particular requirements for the safety of associated equipment of X-ray equipment.

All requirements addressing integrated X-RAY TUBE ASSEMBLIES are covered by this particular standard. Therefore IEC 60601-2-28 does not apply to ME EQUIPMENT in the scope of this International Standard.
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.
Transition Period
FDA recognition of IEC 60601-2-65 Edition 1.1 2017-05 CONSOLIDATED VERSION [Rec# 12-311] will be superseded by recognition of IEC 60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION [Rec# 12-340]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-311] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 12-311] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.1800 System, X-Ray, Extraoral Source, Digital Class 2 MUH
§872.1800 Unit, X-Ray, Extraoral With Timer Class 2 EHD
Relevant FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Cosmin Hilohi
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/DXRS/
  301-796-5882
  MIKE.HILOHI@FDA.HHS.GOV
 David Spelic
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/DXRS/
  301-796-5893
  DAVID.SPELIC@FDA.HHS.GOV
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Radiology
*These are provided as examples and others may be applicable.
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