EN ISO 16645:2019
(Main)Radiological protection - Medical electron accelerators - Requirements and recommendations for shielding design and evaluation (ISO 16645:2016)
Radiological protection - Medical electron accelerators - Requirements and recommendations for shielding design and evaluation (ISO 16645:2016)
ISO 16645:2016 is applicable to medical electron linear accelerators i.e. linear accelerators with nominal energies of the beam ranging from 4 MV to 30 MV, including particular installations such as robotic arm, helical intensity modulated radiotherapy devices and dedicated devices for intra operative radiotherapy (IORT) with electrons.
The cyclotrons and the synchrotrons used for hadrontherapy are not considered.
The radiation protection requirements and recommendations given in ISO 16645:2016 cover the aspects relating to regulations, shielding design goals and other design criteria, role of the manufacturers, of the radiation protection officer or qualified expert and interactions between stakeholders, radiations around a linear accelerator, shielding for conventional and special devices (including shielding materials and transmission values, calculations for various treatment room configurations, duct impact on radiation protection) and the radiological monitoring (measurements).
Strahlenschutz - Medizinische Elektronenbeschleuniger-Anlagen - Anforderungen und Empfehlungen an die Ausführung der Abschirmung und deren Bewertung (ISO 16645:2016, korrigierte Fassung 2016 11)
Diese Internationale Norm gilt für medizinische lineare Elektronenbeschleuniger, d. h. lineare Beschleuniger mit Nennstrahlenergien von 4 MV bis 30 MV einschließlich spezieller Installationen wie robotergestützter Geräte, helikaler fluenzmodulierter Strahlentherapiegeräte und spezieller Geräte für die intraoperative Strahlentherapie (IORT) mit Elektronen.
Für die Hadrontherapie eingesetzte Zyklotrone und Synchrotrone werden nicht berücksichtigt.
Die Strahlenschutzanforderungen und -empfehlungen in dieser Internationalen Norm behandeln die Aspekte in Bezug auf Verordnungen, die Ziele der Abschirmungsgestaltung und anderer Gestaltungskriterien, die Rolle der Hersteller, des Strahlungsschutzbeauftragten oder qualifizierten Experten und die Interaktionen zwischen Stakeholdern, Strahlungen im Umfeld eines linearen Beschleunigers, die Abschirmungen für konventionelle und spezielle Geräte (einschließlich Abschirmungsmaterialien und Übertragungswerte, Berechnungen für verschiedene Behandlungsraumkonfigurationen, die Auswirkung von Kanälen auf den Strahlenschutz) und die radiologische Überwachung (Messungen).
ANMERKUNG 1 Anhang A enthält Übertragungswerte für die häufigsten Abschirmungsmaterialien.
ANMERKUNG 2 Anhang B enthält unterstützende Daten für die Berechnung der Abschirmung.
ANMERKUNG 3 Anhang C enthält ein Beispiel für die Berechnung konventioneller Geräte und eines Standard-Labyrinths.
Radioprotection - Accélérateurs médicaux d'électrons - Exigences et recommandations pour la conception et l'évaluation du blindage (ISO 16645:2016)
L'ISO 16645:2016 s'applique aux accélérateurs linéaires d'électrons médicaux, c'est-à-dire aux accélérateurs linéaires avec des énergies nominales de faisceau dans la gamme de 4 MV à 30 MV, y compris les installations particulières telles que le bras robotisé, les appareils de radiothérapie hélicoïdale avec modulation d'intensité et les appareils dédiés à la radiothérapie peropératoire (IORT) avec électrons.
Les cyclotrons et les synchrotrons utilisés pour l'hadronthérapie ne sont pas considérés.
Les exigences et recommandations en matière de radioprotection données dans l'ISO 16645:2016 couvrent les aspects liés aux réglementations, aux objectifs de conception de la protection radiologique et autres critères de conception, au rôle des fabricants, de la personne compétente en radioprotection ou de l'expert qualifié et aux interactions entre les parties prenantes, aux rayonnements autour d'un accélérateur linéaire, à la protection pour les appareils conventionnels et spéciaux (y compris les matériaux de protection et les valeurs de transmission, les calculs pour différentes configurations de salle de traitement, l'impact des conduits sur la radioprotection) et à la surveillance radiologique (mesurages).
NOTE 1 L'Annexe A procure des valeurs de transmission pour les matériaux de protection les plus courants.
NOTE 2 L'Annexe B fournit des données servant au calcul de la protection radiologique.
NOTE 3 L'Annexe C donne un exemple de calcul pour un appareil conventionnel et une chicane standard.
Radiološka zaščita - Medicinski elektronski pospeševalniki - Zahteve in priporočila za snovanje in ocenjevanje zaščitnih zaslonov (ISO 16645:2016)
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
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2019
Radiološka zaščita - Medicinski elektronski pospeševalniki - Zahteve in priporočila
za snovanje in ocenjevanje zaščitnih zaslonov (ISO 16645:2016)
Radiological protection - Medical electron accelerators - Requirements and
recommendations for shielding design and evaluation (ISO 16645:2016)
Strahlenschutz - Medizinische Elektronenbeschleuniger-Anlagen - Anforderungen und
Empfehlungen an die Ausführung der Abschirmung und deren Bewertung (ISO
16645:2016)
Radioprotection - Accélérateurs médicaux d'électrons - Exigences et recommandations
pour la conception et l'évaluation du blindage (ISO 16645:2016)
Ta slovenski standard je istoveten z: EN ISO 16645:2019
ICS:
11.040.99 Druga medicinska oprema Other medical equipment
13.280 Varstvo pred sevanjem Radiation protection
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 16645
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2019
EUROPÄISCHE NORM
ICS 13.280
English Version
Radiological protection - Medical electron accelerators -
Requirements and recommendations for shielding design
and evaluation (ISO 16645:2016)
Radioprotection - Accélérateurs médicaux d'électrons - Strahlenschutz - Medizinische
Exigences et recommandations pour la conception et Elektronenbeschleuniger-Anlagen - Anforderungen
l'évaluation du blindage (ISO 16645:2016) und Empfehlungen an die Ausführung der
Abschirmung und deren Bewertung (ISO 16645:2016)
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 16645:2019 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
The text of ISO 16645:2016 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 16645:2019 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 Kingdom.
Endorsement notice
The text of ISO 16645:2016 has been approved by CEN as EN ISO 16645:2019 without any modification.
INTERNATIONAL ISO
STANDARD 16645
First edition
2016-10-01
Corrected version
2016-11-15
Radiological protection — Medical
electron accelerators — Requirements
and recommendations for shielding
design and evaluation
Radioprotection — Accélérateurs médicaux d’électrons — Exigences
et recommandations pour la conception et l’évaluation du blindage
Reference number
ISO 16645:2016(E)
©
ISO 2016
ISO 16645:2016(E)
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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ii © ISO 2016 – All rights reserved
ISO 16645:2016(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 Quantities . 1
3.2 Definitions . 4
4 Shielding design goals and other design criteria . 6
4.1 Shielding design goals. 6
4.2 Shielding design assumptions . 7
5 Role of the manufacturers, of the radiation protection officer or qualified expert
and interactions between stakeholders . 8
5.1 General . 8
5.2 Linear accelerator manufacturer . 8
5.3 Shielding material vendor . 9
5.4 Architectural firm/general contractor .10
5.5 Radiation protection officer or qualified expert .10
5.6 The licensee .11
6 Radiation fields around a linear electron accelerator .11
6.1 General .11
6.2 X-ray radiation .11
6.2.1 Primary X-ray beam .11
6.2.2 Primary electron beam bremsstrahlung .12
6.2.3 Secondary X-ray radiation .12
6.2.4 Tertiary X-ray radiation.13
6.3 Neutron radiation .13
6.3.1 General.13
6.3.2 Direct neutron radiation .14
6.3.3 Scattered and thermal neutron radiation.14
6.3.4 Primary barrier neutron radiation .15
6.4 γ radiation .15
6.4.1 General.15
6.4.2 Maze γ radiation . .15
6.4.3 Door γ radiation.15
6.4.4 Primary barrier γ radiation .15
6.4.5 Air γ radiation .16
7 Shielding materials and transmission values .16
8 General formalism for shielding calculation .18
9 Shielding calculation for conventional devices .20
9.1 General .20
9.2 Primary barriers .20
9.2.1 Radiation components .20
9.2.2 Barrier with a unique material .21
9.2.3 Barrier with multiple layers . .21
9.3 Secondary barriers .22
9.3.1 Radiation components .
...
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