Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

053

Date of Entry 12/23/2019

FR Recognition Number

4-262

Standard

(Included in ASCA)

IEC 80601-2-60 Edition 2.0 2019-06
Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment

Scope/Abstract

This part of IEC 80601 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.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.

NOTE See also 4.2 of the general 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.

Public Law, CFR Citation(s) and Procode(s)*

Regulation Number	Device Name	Device Class	Product Code
§872.4120	Handpiece, Rotary Bone Cutting	Class 2	KMW
§872.4200	Controller, Foot, Handpiece And Cord	Class 1	EBW
§872.4200	Handpiece, Belt And/Or Gear Driven, Dental	Class 1	EFA
§872.4200	Handpiece, Air-Powered, Dental	Class 1	EFB
§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
§872.4200	Handpiece, Air-Powered, Root Canal Irrigation	Class 1	NYL
§872.4850	Scaler, Ultrasonic	Class 2	ELC
§872.6070	Activator, Ultraviolet, For Polymerization	Class 2	EBZ
§872.6640	Unit, Operative Dental	Class 1	EIA

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 2007.

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

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

Bobak Shirmohammadi

FDA/OC/CDRH/OPEQ/OHTI/DHTIB/

301-796-3639

Bobak.Shirmohammadi@fda.hhs.gov

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