IEC 61674 Edition 2.0 2012-11

Standard Organization:

IEC 61674 Edition 2.0 2012-11
Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging

Recognition Date2014-01-30
Recognition List034
Recognition Number12-259
Extent Complete standard
Standards Orgs IEC International Electrotechnical Commission http://www.iec.ch/
STG Radiology
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Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

This International Standard specifies the performance and some related constructional requirements of DIAGNOSTIC DOSIMETERS intended for the measurement of AIR KERMA, AIR KERMA LENGTH PRODUCT or AIR KERMA RATE, in photon radiation fields used in RADIOGRAPHY, including mammography, RADIOSCOPY and COMPUTED TOMOGRAPHY (CT), for X-radiation with generating potentials not greater than 150 kV.

This International Standard is applicable to the performance of DOSIMETERS with VENTED IONIZATION CHAMBERS and/or SEMICONDUCTOR DETECTORS as used in X-ray diagnostic imaging.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§892.5930 Assembly, Tube Housing, X-Ray, Therapeutic Class 2 ITZ
§892.5900 System, Therapeutic, X-Ray Class 2 JAD
§892.5840 System, Simulation, Radiation Therapy Class 2 KPQ
§892.5750 Device, Beam Limiting, Teletherapy, Radionuclide Class 2 IWD
§892.5750 System, Radiation Therapy, Radionuclide Class 2 IWB
§892.5700 System, Applicator, Radionuclide, Remote-Controlled Class 2 JAQ
§892.5650 System, Applicator, Radionuclide, Manual Class 1 IWJ
§892.5050 Accessory - Film Dosimetry System Class 2 MWW

FDA Guidance:

There is no relevant guidance developed at this time.

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