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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 046 Date of Entry 12/23/2016 
FR Recognition Number 4-229
Standard
IEC 80601-2-60 Edition 1.0 2012-02 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
Scope/Abstract
This International Standard applies to the basic safety and essential performance of dental units, dental patient chairs, dental handpieces and dental operating lights, hereafter referred to as dental equipment.

Excluded are amalgamators, sterilizers and dental X-ray equipment.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized
Sub-clause 201.4.3, the Sentence, "DENTAL EQUIPMENT does not have ESSENTIAL PERFORMANCE."
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.

This standard is recognized in part because:
Sub-clause 201.4.3 is in conflict with another recognized standard, see ANSI/AAMI ES60601-1 listed below.
Transition Period
FDA recognition of IEC 80601-2-60 Edition 1.0 2012-02 [Rec# 4-229] will be superseded by recognition of IEC 80601-2-60 Edition 2.0 2019-06 [Rec# 4-262]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-229] until December 27, 2020. After this transition period, declarations of conformity to [Rec# 4-229] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.6070 Activator, Ultraviolet, For Polymerization Class 2 EBZ
§872.6640 Unit, Operative Dental Class 1 EIA
§872.4850 Scaler, Ultrasonic Class 2 ELC
§872.4120 Handpiece, Rotary Bone Cutting Class 2 KMW
§872.4200 Controller, Foot, Handpiece And Cord Class 1 EBW
§872.4200 Handpiece, Air-Powered, Dental Class 1 EFB
§872.4200 Handpiece, Air-Powered, Root Canal Irrigation Class 1 NYL
§872.4200 Handpiece, Belt And/Or Gear Driven, Dental Class 1 EFA
§872.4200 Handpiece, Contra- And Right-Angle Attachment, Dental Class 1 EGS
§872.4200 Handpiece, Direct Drive, Ac-Powered Class 1 EKX
§872.4200 Handpiece, Water-Powered Class 1 EKY
Relevant FDA Guidance and/or Supportive Publications*
1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

2. Guidance for Industry and FDA Staff: Dental Handpieces - Premarket Notification [510(k)] Submissions, Issued May 2, 2007.

3. ANSI/AAMI ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

FDA Technical Contacts
 Lauren Giles
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-9552
  lauren.giles@fda.hhs.gov
 Joel Anderson
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6520
  joel.anderson@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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