Recognized Consensus Standards

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

043

Date of Entry 06/27/2016

FR Recognition Number

12-302

Standard

(Included in ASCA pilot)

IEC 60601-2-44 Edition 3.2: 2016
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography

Extent of Recognition

Partial recognition. The following part(s) of the standard is (are) not recognized:

Sub-clause 203.108 Dosimetry PHANTOM

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

Regulation Number	Device Name	Device Class	Product Code
§892.1750	System, X-Ray, Tomography, Computed	Class 2	JAK
§892.1750	X-Ray, Tomography, Computed, Dental	Class 2	OAS

Relevant FDA Guidance and/or Supportive Publications*

AAMI CR500:2019 Basic Introduction to the IEC 60601 Series

Guidance for Industry, FDA Staff and Third Parties - Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography. Document issued on October 20, 2006

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

Laurel Burk

FDA/OC/CDRH/OPEQ/OIDRH/DRH/DXRS/

301-796-5933

laurel.burk@fda.hhs.gov

Rongping Zeng

FDA/OC/CDRH/OSEL/DIDSR/

301-796-2546

Rongping.Zeng@fda.hhs.gov

Standards Development Organization

IEC

International Electrotechnical Commission