Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 06/07/2021 
FR Recognition Number 12-340
Standard(Included in ASCA)
IEC  60601-2-65 Edition 1.2 2021-05 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
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FDA recognition of IEC 60601-2-65 Edition 1.1 2017-05 CONSOLIDATED VERSION [Rec# 12-311] will be superseded by recognition of IEC 60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION [Rec# 12-340].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
 David Spelic
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/DXRS/
  301-796-5893
  DAVID.SPELIC@FDA.HHS.GOV
 Cosmin Hilohi
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/DXRS/
  301-796-5882
  MIKE.HILOHI@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.
-
-