Recognized Consensus Standards: Medical Devices

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.

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

Regulation Number	Device Name	Device Class	Product Code
§872.1800	Unit, X-Ray, Extraoral With Timer	Class 2	EHD
§872.1800	System, X-Ray, Extraoral Source, Digital	Class 2	MUH

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