EN ISO 19238:2017
(Main)Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics (ISO 19238:2014)
Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics (ISO 19238:2014)
ISO 19238:2014 provides criteria for quality assurance and quality control, evaluation of the performance, and the accreditation of biological dosimetry by cytogenetic service laboratories.
ISO 19238:2014 addresses
a) the confidentiality of personal information, for the customer and the service laboratory,
b) the laboratory safety requirements,
c) the calibration sources and calibration dose ranges useful for establishing the reference dose-effect curves that contribute to the dose estimation from chromosome aberration frequency and the minimum resolvable doses,
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,
h) informative annexes containing sample instructions for customer, sample questionnaire, sample of report, fitting of the low dose-response curve by the method of maximum likelihood and calculating the error of dose estimate, odds ratio method for cases of suspected exposure to a low dose, and sample data sheet for recording aberrations.
Strahlenschutz - Durchführungskriterien für Dienstleistungslaboratorien zur Anwendung der biologischen Dosimetrie mittels zytogenetischer Verfahren (ISO 19238:2014)
Diese Internationale Norm stellt Kriterien für die Qualitätssicherung und Qualitätskontrolle, Validierung der Durchführung und Akkreditierung der biologischen Dosimetrie durch zytogenetische Dienstleistungslaboratorien bereit.
Diese Internationale Norm behandelt
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 Chromosomenaberrationen beitragen, und die niedrigsten nachweisbaren Dosen,
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 ein Musterdatenblatt für die Erfassung der Aberrationen.
Radioprotection - Critères de performance pour les laboratoires de service pratiquant la dosimétrie biologique par cytogénétique (ISO 19238:2014)
L'ISO 19238:2014 fournit des critères pour l'assurance de la qualité et le contrôle de la qualité, l'évaluation des performances et l'accréditation des laboratoires de service pratiquant la dosimétrie biologique par cytogénétique.
L'ISO 19238:2014 porte sur
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-effet de référence qui contribuent à l'estimation de dose à partir de la fréquence des aberrations chromosomiques, et les doses minimum détectables,
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 de la qualité et le contrôle de la qualité,
h) les annexes informatives contenant des exemples: d'instructions pour le client, de questionnaire, de rapport, 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, de méthode du rapport des odds pour les cas d'exposition suspectée à une faible dose, et de tableau type pour le dénombrement des aberrations chromosomiques.
Radiološka zaščita - Merila za delovanje laboratorijev, ki izvajajo biološko dozimetrijo s citogenetiko (ISO 19238:2014)
Standard ISO 19238:2014 določa merila za zagotavljanje in nadzor kakovosti, vrednotenje delovanja in akreditacijo biološke dozimetrije s pomočjo laboratorijev za storitve s področja citogenetike.
ISO 19238:2014 obravnava:
a) zaupnost osebnih podatkov naročnika in laboratorija, ki ponuja storitve;
b) zahteve za varnost laboratorija;
c) vire umerjanja in razpone odmerkov umerjanja, ki so koristni za določanje referenčnih krivulj učinkov odmerka za umerjanje, ki omogočajo ocenjevanje odmerka na podlagi frekvence kromosomskih aberacij in minimalnega razločljivega odmerka;
d) postopek ocenjevanja nestabilnih kromosomskih aberacij, ki se uporabljajo za biološko dozimetrijo;
e) merila za pretvorbo izmerjene frekvence aberacije v oceno absorbiranega odmerka;
f) poročanje o rezultatih;
h) zagotavljanje in nadzor kakovosti;
h) informativne dodatke, ki vsebujejo vzorčna navodila za kupca, vzorčni vprašalnik, vzorčno poročilo, primernost krivulje odziva na majhen odmerek z metodo največje verjetnosti ter izračun napake pri oceni razmerja obetov v primerih domnevne izpostavljenosti nizkemu odmerku in vzorec podatkovnega lista za beleženje aberacij.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2018
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Radiological protection - Performance criteria for service laboratories performing
biological dosimetry by cytogenetics (ISO 19238:2014)
Radioprotection - Critères de performance pour les laboratoires de service pratiquant la
dosimétrie biologique par cytogénétique (ISO 19238:2014)
Ta slovenski standard je istoveten z: EN ISO 19238:2017
ICS:
13.280 Varstvo pred sevanjem Radiation protection
17.240 Merjenje sevanja Radiation measurements
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 19238
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2017
EUROPÄISCHE NORM
ICS 13.280; 17.240
English Version
Radiological protection - Performance criteria for service
laboratories performing biological dosimetry by
cytogenetics (ISO 19238:2014)
Radioprotection - Critères de performance pour les
laboratoires de service pratiquant la dosimétrie
biologique par cytogénétique (ISO 19238:2014)
This European Standard was approved by CEN on 13 September 2017.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 19238:2017 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
The text of ISO 19238:2014 has been prepared by Technical Committee ISO/TC 85 “Nuclear energy,
nuclear technologies, and radiological protection” of the International Organization for Standardization
(ISO) and has been taken over as EN ISO 19238:2017 by 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 April 2018, and conflicting national standards shall be
withdrawn at the latest by April 2018.
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.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 19238:2014 has been approved by CEN as EN ISO 19238:2017 without any modification.
INTERNATIONAL ISO
STANDARD 19238
Second edition
2014-02-01
Radiological protection —
Performance criteria for service
laboratories performing biological
dosimetry by cytogenetics
Radioprotection — Critères de performance pour les laboratoires de
service pratiquant la dosimétrie biologique par cytogénétique
Reference number
ISO 19238:2014(E)
©
ISO 2014
ISO 19238:2014(E)
© ISO 2014
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ii © ISO 2014 – All rights reserved
ISO 19238:2014(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Terms and definitions . 1
3 Dicentric assay . 3
4 Responsibility of the customer . 3
5 Responsibility of the service laboratory. 4
5.1 Setup and sustainment of the QA program . 4
5.2 Responsibility during service . 4
6 Confidentiality of personal information . 5
6.1 Overview . 5
6.2 Applications of the principle of confidentiality . 5
7 Laboratory safety requirements . 6
7.1 Overview . 6
7.2 Microbiological safety requirements . 6
7.3 Chemical safety . 6
7.4 Optical safety requirements . 8
7.5 Safety plan . 8
8 Calibration curve(s) . 9
8.1 Culturing . 9
8.2 Calibration source(s) .10
8.3 Establishment of calibration curve(s) .10
8.4 Minimum resolvable dose measurement .11
9 Scoring unstable chromosome aberrations .11
9.1 Procedure for scoring first-division metaphases .11
9.2 Criteria for scoring .11
10 Criteria for converting a measured aberration frequency into an estimate of
absorbed dose .12
10.1 Overview .12
10.2 Comparison with controls .12
10.3 Testing the distribution of aberrations per cell .12
10.4 Determination of estimated whole-body dose and confidence limits .12
10.5 Acute and non-acute exposure cases .13
10.6 Partial-body and prior-exposure cases .13
11 Reporting of results .15
11.1 General .15
11.2 Content of the report (see Annex C for a standard form) .15
11.3 Interpretation of the results .16
12 Quality assurance and quality control .16
12.1 Overview .16
12.2 Specific requirements .17
Annex A (informative) Sample instructions for customer .19
Annex B (informative) Sample questionnaire .20
Annex C (informative) Sample of report .22
Annex D (informative) Fitting of the low-LET dose-response curve by the method of maximum
likelihood and calculating the error of dose estimate .23
Annex E (informative) Odds ratio method for cases of suspected exposure to a low dose .26
ISO 19238:2014(E)
Annex F (informative) Sample data sheet for recording aberration
...
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