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BS EN ISO 20046:2021

BS EN ISO 20046:2021

$189.07

Radiological protection. Performance criteria for laboratories using Fluorescence In Situ Hybridization (FISH) translocation assay for assessment of exposure to ionizing radiation

Published By Publication Date Number of Pages
BSI 2021 50
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The purpose of this document is to provide criteria for quality assurance (QA), quality control (QC) and evaluation of the performance of biological dosimetry by cytogenetic service laboratories.

This document addresses:

  1. the responsibilities of both the customer and the laboratory;

  2. the confidentiality of personal information, for the customer and the laboratory;

  3. the laboratory safety requirements;

  4. sample processing; culturing, staining and scoring, including the criteria for scoring for translocation analysis by FISH;

  5. the calibration sources and calibration dose ranges useful for establishing the reference doseā€‘response curves that contribute to the dose estimation from chromosome aberration frequency and the detection limit;

  6. the scoring procedure for translocations stained by FISH used for evaluation of exposure;

  7. the criteria for converting a measured aberration frequency into an estimate of absorbed dose (also appears as ā€œdoseā€);

  8. the reporting of results;

  9. the QA and QC;

  10. Annexes A to F containing sample instructions for the customer, sample questionnaire, sample datasheet for recording aberrations, sample of report and fitting of the low dose-response curve by the method of maximum likelihood and calculating the uncertainty of dose estimate.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
13 4 Translocation assay by FISH
4.1 General
4.2 Culturing and fixation
4.3 Types of staining
14 4.4 Scoring
4.5 General requirement of the laboratory
5 Responsibility of the customer
15 6 Responsibility of the laboratory
6.1 Setup and sustainment of the QA program
6.2 Responsibility during service
16 7 Confidentiality of personal information
7.1 Overview
7.2 Applications of the principle of confidentiality
7.2.1 Delegation of responsibilities within the laboratory
17 7.2.2 Requests for analysis
7.2.3 Transmission of confidential information
7.2.4 Anonymity of samples
7.2.5 Reporting of results
7.2.6 Storage of data and results
8 Laboratory safety requirements
8.1 Overview
18 8.2 Microbiological safety requirements
8.3 Chemical safety requirements
19 8.4 Optical safety requirements
8.5 Safety plan
9 Sample processing
9.1 Culturing and staining
20 9.2 Scoring
9.2.1 Criteria for scoring
9.2.2 Conversion of translocation frequencies to genome equivalence
21 10 Background levels of translocations
22 11 Calibration curves
11.1 Calibration source(s)
11.2 Establishment of calibration curve(s)
24 12 Criteria for converting a measured aberration frequency into an estimate of absorbed dose
12.1 Determination of estimated whole-body absorbed dose and confidence limits
12.1.1 General
12.1.2 Comparison with the background level: Characterisation of the minimum detectable dose
27 12.1.3 Confidence limits on the number of translocations
28 12.1.4 Adjustment for background yield
29 12.1.5 Calculation of absorbed dose
30 12.1.6 Calculation of uncertainty on absorbed dose
12.1.7 Acute and non-acute exposure cases
31 12.1.8 Other exposure scenarios
13 Reporting of results
13.1 General
13.2 Content of the report (see Annex C for an example of a standard form)
32 13.3 Interpretation of the results
14 Quality assurance and quality control
14.1 Overview
14.2 Specific requirements
14.2.1 General
14.2.2 Performance checks by inter-laboratory comparisons
33 14.2.3 Performance check of scorer qualification
14.2.4 Performance checks of sample transport integrity
34 14.2.5 Performance checks of sample integrity by service laboratory
14.2.6 Performance checks of instrumentation
14.2.7 Performance checks of sample protocol
14.2.8 Performance checks of sample scoring
14.2.9 Performance checks of result report generation
35 Annex A (informative) Sample instructions for customer
37 Annex B (informative) Sample questionnaire
39 Annex C (informative) Sample of report
40 Annex D (informative) Sample data sheets for recording painted aberrations
42 Annex E (informative) Fitting of the dose response-curve by the method of maximum likelihood and calculating the uncertainty of the absorbed dose estimate
43 Annex F (informative) Process for dose estimation
48 Bibliography

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BS EN ISO 20046:2021
$189.07