| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
057
|
Date of Entry 12/20/2021
|
|
FR Recognition Number
|
7-309
|
| Standard | |
ISO 17099 First edition 2014-11-15
Radiological protection - Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry |
|
Scope/AbstractThis International Standard addresses the following:
a) confidentiality of personal information for the customer and the laboratory;
b) laboratory safety requirements;
c) radiation sources, dose rates, and ranges used for establishing the calibration reference dose-effect curves allowing the dose estimation from CBMN assay yields and the minimum resolvable dose;
d) performance of blood collection, culturing, harvesting, and sample preparation for CBMN assay scoring;
e) scoring criteria;
f) conversion of micronucleus frequency in binucleated cells into an estimate of absorbed dose;
g) reporting of results;
h) quality assurance and quality control;
i) informative annexes containing examples of a questionnaire, instructions for customers, a sheet, a sample report and advice on strengths and limitations of current automated systems for automated micronucleus scoring.
|
|
| Extent of Recognition
|
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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
