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eLibrary > BS ISO 20046:2019 Radiological protection. Performance criteria for laboratories using Fluorescence In Situ Hybridization (FISH) translocation assay for assessment of exposure to ionizing radiation >

BS ISO 20046:2019 Radiological protection. Performance criteria for laboratories using Fluorescence In Situ Hybridization (FISH) translocation assay for assessment of exposure to ionizing radiation, 2019

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BS ISO 20046:2019 Radiological protection. Performance criteria for laboratories using Fluorescence In Situ Hybridization (FISH) translocation assay for assessment of exposure to ionizing radiation, 2019

National foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Translocation assay by FISH [Go to Page]
4.1 General
4.2 Culturing and fixation
4.3 Types of staining
4.4 Scoring
4.5 General requirement of the laboratory
5 Responsibility of the customer
6 Responsibility of the laboratory [Go to Page]
6.1 Setup and sustainment of the QA program
6.2 Responsibility during service
7 Confidentiality of personal information [Go to Page]
7.1 Overview
7.2 Applications of the principle of confidentiality [Go to Page]
7.2.1 Delegation of responsibilities within the laboratory
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 [Go to Page]
8.1 Overview
8.2 Microbiological safety requirements
8.3 Chemical safety requirements
8.4 Optical safety requirements
8.5 Safety plan
9 Sample processing [Go to Page]
9.1 Culturing and staining
9.2 Scoring [Go to Page]
9.2.1 Criteria for scoring
9.2.2 Conversion of translocation frequencies to genome equivalence
10 Background levels of translocations
11 Calibration curves [Go to Page]
11.1 Calibration source(s)
11.2 Establishment of calibration curve(s)
12 Criteria for converting a measured aberration frequency into an estimate of absorbed dose [Go to Page]
12.1 Determination of estimated whole-body absorbed dose and confidence limits [Go to Page]
12.1.1 General
12.1.2 Comparison with the background level: Characterisation of the minimum detectable dose
12.1.3 Confidence limits on the number of translocations
12.1.4 Adjustment for background yield
12.1.5 Calculation of absorbed dose
12.1.6 Calculation of uncertainty on absorbed dose
12.1.7 Acute and non-acute exposure cases
12.1.8 Other exposure scenarios
13 Reporting of results [Go to Page]
13.1 General
13.2 Content of the report (see Annex C for an example of a standard form)
13.3 Interpretation of the results
14 Quality assurance and quality control [Go to Page]
14.1 Overview
14.2 Specific requirements [Go to Page]
14.2.1 General
14.2.2 Performance checks by inter-laboratory comparisons
14.2.3 Performance check of scorer qualification
14.2.4 Performance checks of sample transport integrity
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
Annex A (informative) Sample instructions for customer
Annex B (informative) Sample questionnaire
Annex C (informative) Sample of report
Annex D (informative) Sample data sheets for recording painted aberrations
Annex E (informative) Fitting of the dose response-curve by the method of maximum likelihood and calculating the uncertainty of the absorbed dose estimate
Annex F (informative) Process for dose estimation
Bibliography [Go to Page]

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BS ISO 20046:2019 Radiological protection. Performance criteria for laboratories using Fluorescence In Situ Hybridization (FISH) translocation assay for assessment of exposure to ionizing radiation, 2019

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