Radiological protection - Monitoring and internal dosimetry for staff members exposed to medical radionuclides as unsealed sources (ISO 16637:2016)

ISO 16637:2016 specifies the minimum requirements for the design of professional programmes to monitor workers exposed to the risk of internal contamination via inhalation by the use of radionuclides as unsealed sources in nuclear medicine imaging and therapy departments. It establishes principles for the development of compatible goals and requirements for monitoring programmes and, when adequate, dose assessment. It presents procedures and assumptions for the risk analysis, for the monitoring programmes, and for the standardized interpretation of monitoring data.
ISO 16637:2016 addresses the following items:
a)    purposes of monitoring and monitoring programmes;
b)    description of the different categories of monitoring programmes;
c)    quantitative criteria for conducting monitoring programmes;
d)    suitable methods for monitoring and criteria for their selection;
e)    information that has to be collected for the design of a monitoring programme;
f)     general requirements for monitoring programmes (e.g. detection limits, tolerated uncertainties);
g)    frequencies of measurements;
h)    procedures for dose assessment based on reference levels for routine and special monitoring programmes;
i)     assumptions for the selection of dose-critical parameter values;
j)     criteria for determining the significance of individual monitoring results;
k)    interpretation of workplace monitoring results;
l)     uncertainties arising from dose assessments and interpretation of bioassays data;
m)   reporting/documentation;
n)    quality assurance.
ISO 16637:2016 does not address the following:
-      monitoring and internal dosimetry for the workers exposed to laboratory use of radionuclides such as radioimmunoassay techniques;
-      monitoring and internal dosimetry for the workers involved in the operation, maintenance, and servicing of PET cyclotrons;
-      detailed descriptions of measuring methods and techniques;
-      dosimetry for litigation cases;
-      modelling for the improvement of internal dosimetry;
-      the potential influence of medical treatment of the internal contamination;
-      the investigation of the causes or implications of an exposure;
-      dosimetry for ingestion exposures and for contaminated wounds.

Strahlenschutz - Überwachung und interne Dosimetrie für Beschäftigte, die durch medizinisch genutzte Radionuklide aus offenen Quellen exponiert wurden (ISO 16637:2016)

Radioprotection - Surveillance et dosimétrie interne des travailleurs exposés lors des utilisations médicales des radioéléments en sources non scellées (ISO 16637:2016)

L'ISO 16637:2016 décrit les exigences minimales permettant d'établir des programmes de surveillance professionnelle des travailleurs exposés à un risque de contamination interne par inhalation lors de l'utilisation, à des fins diagnostiques ou thérapeutiques, de radionucléides en sources non scellées dans les services de médecine nucléaire. Elle établit des principes pour l'élaboration d'objectifs et d'exigences compatibles avec les programmes de surveillance et, le cas échéant, l'estimation de la dose. Elle présente les procédures et les hypothèses considérées pour l'analyse du risque, pour la mise en place des programmes de surveillance et pour l'interprétation normalisée des données de surveillance.
L'ISO 16637:2016 traite des points suivants:
a)    objectifs de la surveillance et des programmes de surveillance;
b)    description des différentes catégories de programmes de surveillance;
c)    critères quantitatifs pour la conduite des programmes de surveillance;
d)    méthodes valables pour la surveillance et leurs critères de sélection;
e)    informations à collecter pour l'élaboration d'un programme de surveillance;
f)     exigences générales pour les programmes de surveillance (par exemple? limites de détection, incertitudes tolérées);
g)    fréquence des mesurages;
h)    procédures d'estimation dosimétrique fondées sur des niveaux de référence pour les programmes de surveillance de routine et post-incidentelle;
i)     hypothèses pour le choix des paramètres influençant l'estimation dosimétrique;
j)     critères pour déterminer si les résultats de la surveillance individuelle sont significatifs;
k)    interprétation des résultats de la surveillance aux postes de travail;
l)     incertitudes liées aux estimations de la dose et à l'interprétation des données de mesurage in vivo et d'analyse in vitro;
m)   compte-rendu/documentation;
n)    assurance de la qualité.
L'ISO 16637:2016 ne traite pas des points suivants:
- surveillance et dosimétrie interne pour les travailleurs exposés lors des utilisations en laboratoire de radionucléides, par exemple lors des dosages radio-immunologiques;
- surveillance et dosimétrie interne pour les travailleurs impliqués dans l'exploitation, la maintenance et l'entretien des cyclotrons TEP;
- descriptions détaillées des méthodes et techniques de mesurage;
- dosimétrie dans les cas litigieux;
- modélisation pour l'amélioration de la dosimétrie interne;
- influence potentielle d'un traitement médical de la contamination interne;
- investigation des causes ou des conséquences d'une exposition;
- dosimétrie pour les expositions par ingestion et par plaies contaminées.

Radiološka zaščita - Nadzorovanje in notranja dozimetrija za člane osebja, izpostavljene medicinskim radionuklidom kot odprtemu viru sevanja (ISO 16637:2016)

Standard ISO 16645:2016 se uporablja za medicinske elektronske linearne pospeševalnike, tj. linearne pospeševalnike z nominalnimi energijami žarka od 4 MV do 30 MV, vključno s posebnimi instalacijami, kot so robotska roka, radioterapevtske naprave, ki so modulirane s spiralno intenziteto, in naprave, namenjene za medoperacijsko radioterapijo (IORT) z elektroni.
Ciklotroni in sinhrotroni, ki se uporabljajo pri hadronski terapiji, niso upoštevani v tem dokumentu.
Zahteve in priporočila za radiološko zaščito, ki so podani v standardu ISO 16645:2016, obravnavajo vidike, povezane s predpisi, cilji snovanja zaščitnih zaslonov in drugih kriterijev snovanja, vlogo izdelovalcev, pooblaščenega izvedenca varstva pred sevanji ali usposobljenega strokovnjaka ter interakcijami med deležniki, sevanjem okoli linearnega pospeševalnika, zaščito za konvencionalne in posebne naprave (vključno z zaščitnimi materiali in vrednostmi transmisije, izračuni za različne konfiguracije ambulant, vpliv cevi na radiološko zaščito) ter nadzorom sevanja (meritve).

General Information

Status
Published
Publication Date
11-Jun-2019
Withdrawal Date
30-Dec-2019
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
12-Jun-2019
Due Date
28-Nov-2020
Completion Date
12-Jun-2019

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 16637:2019
01-september-2019
Radiološka zaščita - Nadzorovanje in notranja dozimetrija za člane osebja,
izpostavljene medicinskim radionuklidom kot odprtemu viru sevanja (ISO
16637:2016)
Radiological protection - Monitoring and internal dosimetry for staff members exposed to
medical radionuclides as unsealed sources (ISO 16637:2016)
Strahlenschutz - Überwachung und interne Dosimetrie für Personal, das durch
medizinische Radionuklide aus offenen Quellen exponiert wurde (ISO 16637:2016)
Radioprotection - Surveillance et dosimétrie interne des travailleurs exposés lors des
utilisations médicales des radioéléments en sources non scellées (ISO 16637:2016)
Ta slovenski standard je istoveten z: EN ISO 16637:2019
ICS:
13.280 Varstvo pred sevanjem Radiation protection
SIST EN ISO 16637:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16637:2019

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SIST EN ISO 16637:2019


EN ISO 16637
EUROPEAN STANDARD

NORME EUROPÉENNE

June 2019
EUROPÄISCHE NORM
ICS 13.280
English Version

Radiological protection - Monitoring and internal
dosimetry for staff members exposed to medical
radionuclides as unsealed sources (ISO 16637:2016)
Radioprotection - Surveillance et dosimétrie interne Strahlenschutz - Überwachung und interne Dosimetrie
des travailleurs exposés lors des utilisations médicales für Personal, das durch medizinische Radionuklide aus
des radioéléments en sources non scellées (ISO offenen Quellen exponiert wurde (ISO 16637:2016)
16637:2016)
This European Standard was approved by CEN on 8 March 2019.

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: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16637:2019 E
worldwide for CEN national Members.

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SIST EN ISO 16637:2019
EN ISO 16637:2019 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 16637:2019
EN ISO 16637:2019 (E)
European foreword
The text of ISO 16637:2016 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 16637:2019 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 December 2019, and conflicting national standards
shall be withdrawn at the latest by December 2019.
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 Ki
...

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