ISO 19238:2023-08

Strahlenschutz - Durchführungskriterien für Dienstleistungslaboratorien zur Anwendung der biologischen Dosimetrie mittels zytogenetischer Verfahren - Dizentrische Chromosomenanalyse

Englischer Titel: Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics - Dicentric assay
Ausgabedatum: 2023-08
Originalsprachen: Englisch
Seiten: 39

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Ausgabedatum: 2023-08
Originalsprachen: Englisch
Seiten: 39

Produktinformationen auf dieser Seite:

Inhaltsverzeichnis
ICS
Ersatzvermerk
Normen mitgestalten

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Inhaltsverzeichnis

Inhalt (en)

Foreword
Introduction
Scope
Normative references
Terms and definitions
Abbreviated terms
Dicentric assay
Responsibility of the requestor
Responsibility of the service laboratory
- Setup and sustainment of the QA program
- Responsibility during service
Confidentiality of personal information
- Overview
- Applications of the principle of confidentiality
  - Delegation of responsibilities within the laboratory
  - Requests for analysis
  - Transmission of confidential information
  - Anonymity of samples
  - Reporting of results
  - Storage
  - Data security plan
Laboratory safety requirements
- Overview
- Microbiological safety requirements
- Chemical safety
- Optical safety requirements
Sample processing
- Culturing
- Scoring
  - Coding of samples and slides
  - Scoring techniques
  - Procedure for scoring first-division metaphases
  - Laboratory scoring expertise
Calibration curves
- Calibration source(s)
- Establishment of calibration curve(s)
Criteria for converting a measured aberration frequency into an estimate of absorbed dose
- General
- Testing the distribution of aberrations per cell
- Comparison with the background level: Characterisation of the minimum detectable dose
- Confidence limits on the number of dicentrics
- Calculation of absorbed dose for whole-body exposures
- Calculation of uncertainty on absorbed dose
- Acute and non-acute exposure cases
- Partial body and prior exposure cases
- Other exposure scenarios
Reporting of results
- General
- Content of the report (see Annex C for a standard form)
- Interpretation of the results
Quality assurance and quality control
- Overview
- Specific requirements
  - General
  - Performance checks by laboratory inter-comparisons
  - Periodical performance check of scorer qualification
  - Performance checks of sample transport integrity
  - Performance checks of sample integrity by service laboratory
  - Performance checks for instrumentation
  - Performance checks of sample protocol
  - Performance checks of sample scoring
  - Performance checks of dose and confidence limits estimation
  - Performance checks for result report generation
Sample instructions for requestor (informative)
Sample questionnaire (informative)
Sample of report (informative)
Fitting of the low-LET dose-response curve by the method of maximum likelihood and calculating the error of dose estimate (informative)
- Fitting procedure
- Calculating the error of dose estimate
Odds ratio method for cases of suspected exposure to a low dose (informative)
Decision threshold and detection limit (informative)
- General
- R script for calculating the decision threshold
Sample data sheet for recording aberrations (informative)
Bibliography

ICS

13.280, 17.240

Ersatzvermerk

Dieses Dokument ersetzt ISO 19238:2014-02 .

Normen mitgestalten

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