Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

026

Date of Entry 03/14/2011

FR Recognition Number

12-221

Standard

IEC 61223-3-4 First edition 2000-03
Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray

Scope/Abstract

This part of IEC 61223 applies to those components of dental X-RAY EQUIPMENT using radiographic imaging systems which influence the image quality and PATIENT dose.

This standard applies to the performance of the ACCEPTANCE TEST on dental X-RAY EQUIPMENT with intra-oral X-RAY IMAGE RECEPTOR and dental X-RAY EQUIPMENT with extra-oral X-RAY IMAGE RECEPTOR (for example, dental panoramic X-RAY EQUIPMENT or cephalometric X-RAY).

This standard applies to dental film and digital image acquisition and processing.

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
§872.1810	Unit, X-Ray, Intraoral	Class 2	EAP

Relevant FDA Guidance and/or Supportive Publications*

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

Michael Mendelson

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

301-796-6280

michael.mendelson@fda.hhs.gov

William Jung

FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/

301-796-6228

william.jung@fda.hhs.gov

Standards Development Organization

IEC

International Electrotechnical Commission