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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 063 Date of Entry 12/23/2024 
FR Recognition Number 12-365
Standard
IEC  60627 Edition 3.0 2013-07
Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids
Scope/Abstract
This International Standard is applicable to ANTI-SCATTER GRIDS used in medical diagnostic Xray imaging equipment. ANTI-SCATTER GRIDS are used to reduce the incidence of SCATTERED RADIATION, produced particularly in the body of the PATIENT, upon the IMAGE RECEPTION AREA and thus to improve the contrast of the X-RAY PATTERN. This International Standard specifies the definitions, determination and indication of characteristics of ANTI-SCATTER GRIDS.

In this standard only LINEAR GRIDS are considered.

Since at present only FOCUSED GRIDS are used in mammography, this standard is restricted to FOCUSED GRIDS where MAMMOGRAPHIC ANTI-SCATTER GRIDS are concerned.

This standard is not intended to be applied for ACCEPTANCE TESTS.

This standard does not cover the homogeneity of performance over the area of a grid.

This standard is intended to be applied for the determination of the characteristics of ANTISCATTER GRIDS under test conditions. These conditions are not usually available at the site of the RESPONSIBLE ORGANIZATION.
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
§892.1715 Full Field Digital, System, X-Ray, Mammographic Class 2 MUE
N/A Digital Breast Tomosynthesis Class 3 OTE
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.

Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Full-Field Digital Mammography System, Issued March 2012.
FDA Technical Contacts
 Stephen Glick
  FDA/OC/CDRH/OSEL/DIDSR/
  301-796-6220
  stephen.glick@fda.hhs.gov
 Jabari Calliste
  CDRH/OPEQ/OHTVIIIB/
  301-348-3044
  jabari.calliste@fda.hhs.gov
 Paramita Sengupta
  CDRH/OPEQ/OHTVIIIC
  --
  Paramita.Sengupta@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Radiology
*These are provided as examples and others may be applicable.
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