1 Scope
This document gives guidance on
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a) confidentiality of personal information for the customer and the laboratory,
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b) laboratory safety requirements,
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c) calibration sources and calibration dose ranges useful for establishing the reference dose-response curves that contribute to the dose estimation from CBMN assay yields and the detection limit,
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d) performance of blood collection, culturing, harvesting, and sample preparation for CBMN assay scoring,
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e) scoring criteria,
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f) conversion of micronucleus frequency in BNCs into an estimate of absorbed dose,
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g) reporting of results,
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h) quality assurance and quality control, and
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i) informative annexes containing sample instructions for customers, sample questionnaire, a microscope scoring data sheet, and a sample report.
This document excludes methods for automated scoring of CBMN.