SIST EN ISO 19238:2023
(Main)Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics - Dicentric assay (ISO 19238:2023)
Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics - Dicentric assay (ISO 19238:2023)
This document provides criteria for quality assurance and quality control, evaluation of the performance and the accreditation of biological dosimetry by cytogenetic service laboratories using the dicentric assay performed with manual scoring.
This document is applicable to
a) the confidentiality of personal information, for the requestor and the service laboratory,
b) the laboratory safety requirements,
c) the calibration sources and calibration dose ranges useful for establishing the reference dose-response curves that contribute to the dose estimation from unstable chromosome aberration frequency and the detection limit,
d) the scoring procedure for unstable chromosome aberrations used for biological dosimetry,
e) the criteria for converting a measured aberration frequency into an estimate of absorbed dose,
f) the reporting of results,
g) the quality assurance and quality control, and
h) informative annexes containing sample instructions for requestor (see Annex A), sample questionnaire (see Annex B), sample report (see Annex C), fitting of the low dose-response curve by the method of maximum likelihood and calculating the error of the dose estimate (see Annex D), odds ratio method for cases of suspected exposure to a low dose (see Annex E), a method for determining the decision threshold and detection limit (see Annex F) and sample data sheet for recording aberrations (see Annex G).
Strahlenschutz - Durchführungskriterien für Dienstleistungslaboratorien zur Anwendung der biologischen Dosimetrie mittels zytogenetischer Verfahren - Dizentrische Chromosomenanalyse (ISO 19238:2023)
Dieses Dokument stellt Kriterien für die Qualitätssicherung und Qualitätskontrolle, Validierung der Durchführung und Akkreditierung der biologischen Dosimetrie durch zytogenetische Dienstleistungslaboratorien, die die dizentrische Chromosomenanalyse mit manueller Auswertung verwenden, bereit.
Dieses Dokument behandelt Folgendes
a) die Vertraulichkeit von persönlichen Angaben, in Bezug auf den Auftraggeber und das Dienstleistungslaboratorium,
b) die Laboratorium-Sicherheitsanforderungen,
c) die sinnvollen Kalibrierquellen (Kalibrierstrahler) und Kalibrierdosisbereiche zur Erstellung der Referenz-Dosis-Wirkungs-Kurven, die zur Dosisabschätzung anhand der Häufigkeit von instabilen Chromosomenaberrationen beitragen, und der Nachweisgrenzen,
d) das Auswerteverfahren für instabile Chromosomenaberrationen, die für die biologische Dosimetrie verwendet werden,
e) die Kriterien für die Abschätzung der absorbierten Dosis, anhand der Häufigkeit von beobachteten Aberrationen,
f) die Berichterstattung der Ergebnisse,
g) die Qualitätssicherung und Qualitätskontrolle,
h) informative Anhänge mit Musteranweisungen für Auftraggeber, Musterfragebogen, Musterbericht, Anpassung der Niedrigdosis-Wirkungs-Kurve nach dem Maximum-Likelihood-Verfahren und Berechnung des Fehlers der Dosisschätzung, Odds Ratio-Verfahren für Fälle einer vermuteten Exposition mit geringer Dosis, sowie eine Beispielberechnung und ein Musterdatenblatt für die Erfassung der Aberrationen.
Radioprotection - Critères de performance pour les laboratoires de service pratiquant la dosimétrie biologique par cytogénétique - Dénombrement des dicentriques (ISO 19238:2023)
Le présent document fournit des critères pour l’assurance qualité et le contrôle qualité, l’évaluation des performances et l’accréditation des laboratoires de service pratiquant la dosimétrie biologique par cytogénétique via un dénombrement manuel des dicentriques.
Le présent document s'applique à
a) la confidentialité des informations personnelles pour le demandeur et le laboratoire de service,
b) les exigences de sécurité du laboratoire,
c) les sources d’étalonnage et les gammes de doses d’étalonnage utiles pour établir les courbes dose-réponse de référence qui contribuent à l’estimation de dose à partir de la fréquence des aberrations chromosomiques instables, et la limite de détection,
d) la procédure de dénombrement des aberrations chromosomiques instables utilisées pour la dosimétrie biologique,
e) les critères pour convertir une fréquence mesurée d’aberrations en une estimation de dose absorbée,
f) la présentation des résultats,
g) l’assurance qualité et le contrôle qualité, et
h) les annexes informatives contenant des exemples: d’instructions pour le demandeur (voir Annexe A), de questionnaire (voir Annexe B), de rapport (voir Annexe C), d’ajustement de la courbe dose-réponse aux faibles doses par la méthode du maximum de vraisemblance et en tenant compte de l’erreur de l’estimation de dose (voir Annexe D), de méthode de rapport de chances pour les cas d’exposition suspectée à une faible dose(voir Annexe E), de méthode de détermination du seuil de décision et de la limite de détection (voir Annexe F) et de tableau type pour le dénombrement des aberrations chromosomiques (voir Annexe G).
Radiološka zaščita - Merila za delovanje laboratorijev, ki izvajajo biološko dozimetrijo s citogenetiko - Diecentrična analiza (ISO 19238:2023)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 19238:2023
01-november-2023
Radiološka zaščita - Merila za delovanje laboratorijev, ki izvajajo biološko
dozimetrijo s citogenetiko - Diecentrična analiza (ISO 19238:2023)
Radiological protection - Performance criteria for service laboratories performing
biological dosimetry by cytogenetics - Dicentric assay (ISO 19238:2023)
Strahlenschutz - Durchführungskriterien für Dienstleistungslaboratorien zur Anwendung
der biologischen Dosimetrie mittels zytogenetischer Verfahren - Dizentrische
Chromosomenanalyse (ISO 19238:2023)
Radioprotection - Critères de performance pour les laboratoires de service pratiquant la
dosimétrie biologique par cytogénétique - Dénombrement des dicentriques (ISO
19238:2023)
Ta slovenski standard je istoveten z: EN ISO 19238:2023
ICS:
13.280 Varstvo pred sevanjem Radiation protection
17.240 Merjenje sevanja Radiation measurements
SIST EN ISO 19238:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 19238:2023
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SIST EN ISO 19238:2023
EN ISO 19238
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2023
EUROPÄISCHE NORM
ICS 13.280; 17.240 Supersedes EN ISO 19238:2017
English Version
Radiological protection - Performance criteria for service
laboratories performing biological dosimetry by
cytogenetics - Dicentric assay (ISO 19238:2023)
Radioprotection - Critères de performance pour les Strahlenschutz - Durchführungskriterien für
laboratoires de service pratiquant la dosimétrie Dienstleistungslaboratorien zur Anwendung der
biologique par cytogénétique - Dénombrement des biologischen Dosimetrie mittels zytogenetischer
dicentriques (ISO 19238:2023) Verfahren - Dizentrische Chromosomenanalyse (ISO
19238:2023)
This European Standard was approved by CEN on 12 August 2023.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 19238:2023 E
worldwide for CEN national Members.
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SIST EN ISO 19238:2023
EN ISO 19238:2023 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 19238:2023
EN ISO 19238:2023 (E)
European foreword
This document (EN ISO 19238:2023) has been prepared by Technical Committee ISO/TC 85 "Nuclear
energy, nuclear technologies, and radiological protection" in collaboration with Technical Committee
CEN/TC 430 “Nuclear energy, nuclear technologies, and radiological protection” the secretariat of
which is held by AFNOR.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by March 2024, and conflicting national standards shall
be withdrawn at the latest by March 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 19238:2017.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bul
...
SLOVENSKI STANDARD
oSIST prEN ISO 19238:2022
01-november-2022
Radiološka zaščita - Merila za delovanje laboratorijev, ki izvajajo biološko
dozimetrijo s citogenetiko - Diecentrična analiza (ISO/DIS 19238:2022)
Radiological protection - Performance criteria for service laboratories performing
biological dosimetry by cytogenetics - The dicentric assay (ISO/DIS 19238:2022)
Strahlenschutz - Durchführungskriterien für Dienstleistungslaboratorien zur Anwendung
der biologischen Dosimetrie mittels zytogenetischer Verfahren - Dizentrischer Test
(ISO/DIS 19238:2022)
Radioprotection - Critères de performance pour les laboratoires de service pratiquant la
dosimétrie biologique par cytogénétique (ISO/DIS 19238:2022)
Ta slovenski standard je istoveten z: prEN ISO 19238
ICS:
13.280 Varstvo pred sevanjem Radiation protection
17.240 Merjenje sevanja Radiation measurements
oSIST prEN ISO 19238:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 19238:2022
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oSIST prEN ISO 19238:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 19238
ISO/TC 85/SC 2 Secretariat: AFNOR
Voting begins on: Voting terminates on:
2022-08-31 2022-11-23
Radiological protection — Performance criteria for
service laboratories performing biological dosimetry by
cytogenetics - The dicentric assay
ICS: 17.240; 13.280
THIS DOCUMENT IS A DRAFT CIRCULATED
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oSIST prEN ISO 19238:2022
ISO/DIS 19238:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 19238
ISO/TC 85/SC 2 Secretariat: AFNOR
Voting begins on: Voting terminates on:
Radiological protection — Performance criteria for
service laboratories performing biological dosimetry by
cytogenetics - The dicentric assay
ICS: 17.240; 13.280
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oSIST prEN ISO 19238:2022
ISO/DIS 19238:2022(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative referen
...
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