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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 057 Date of Entry 12/20/2021 
FR Recognition Number 7-310
Standard
ISO  19238 Second edition 2014-02-01
Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics
Scope/Abstract
This International Standard provides criteria for quality assurance and quality control, evaluation of the performance, and the accreditation of biological dosimetry by cytogenetic service laboratories.
This International Standard addresses
a) the confidentiality of personal information, for the customer and the service laboratory,
b) the laboratory safety requirements,
c) the calibration sources and calibration dose ranges useful for establishing the reference dose-effect curves that contribute to the dose estimation from chromosome aberration frequency and the minimum resolvable doses,
d) the scoring procedure for unstable chromosome aberrations used for biological dosimetry,
e) the criteria for converting a measured aberration frequency into an estimate of absorbed dose,
f) the reporting of results,
g) the quality assurance and quality control,
h) informative annexes containing sample instructions for customer, sample questionnaire, sample of report, fitting of the low dose-response curve by the method of maximum likelihood and calculating the error of dose estimate, odds ratio method for cases of suspected exposure to a low dose, and sample data sheet for recording aberrations.
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)*
809.3(a) In Vitro Diagnostic Products for Human Use. Definitions
Relevant FDA Guidance and/or Supportive Publications*
1) Radiation Biodosimetry Medical Countermeasure Devices: Guidance for Industry and Food and Drug Administration Staff. Issued April 18, 2016.
2) International Atomic Energy Agency. Cytogenetic Dosimetry: Applications in Preparedness for and Response to Radiation Emergencies. Published September 2011.


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 Contact
 Daniela Stricklin
  FDA/CDRH/OPEQ/OIDRH/DMGP/MGB
  301-837-7253
  Daniela.Stricklin@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
*These are provided as examples and others may be applicable.
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