Radiological protection - Sealed radioactive sources - General requirements and classification (ISO 2919:2012)

ISO 2919:2012 establishes a classification system for sealed radioactive sources that is based on test performance and specifies general requirements, performance tests, production tests, marking and certification. It provides a set of tests by which manufacturers of sealed radioactive sources can evaluate the safety of their products in use and users of such sources can select types which are suitable for the required application, especially where protection against the release of radioactive material, with consequent exposure to ionizing radiation, is concerned. ISO 2919:2012 can also serve as guidance to regulating authorities.
The tests fall into several groups, including, for example, exposure to abnormally high and low temperatures and a variety of mechanical tests. Each test can be applied in several degrees of severity. The criterion of pass or fail depends on leakage of the contents of the sealed radioactive source.
Although ISO 2919:2012 classifies sealed sources by a variety of tests, it does not imply that a sealed source will maintain its integrity if used continuously at the rated classification. For example, a sealed source tested for 1 h at 600 °C might, or might not, maintain its integrity if used continuously at 600 °C.
A list of the main typical applications of sealed radioactive sources, with a suggested test schedule for each application, is given in Table 3. The tests constitute minimum requirements corresponding to the applications in the broadest sense. Factors to be considered for applications in especially severe conditions are listed in 4.2.
ISO 2919:2012 makes no attempt to classify the design of sources, their method of construction or their calibration in terms of the radiation emitted. Radioactive materials inside a nuclear reactor, including sealed sources and fuel elements, are not covered by ISO 2919:2012.

Strahlenschutz - Umschlossene radioaktive Stoffe - Allgemeine Anforderungen und Klassifikation (ISO 2919:2012)

Diese Internationale Norm legt für umschlossene radioaktive Stoffe (im Folgenden kurz als "Strahler" be-zeichnet) auf der Grundlage ihres Prüfverhaltens ein Klassifikationssystem fest und spezifiziert allgemeine Anforderungen, Belastbarkeitsprüfungen, Produktionsprüfungen, Kennzeichnung und Zertifizierung. Be-schrieben werden eine Reihe von Prüfungen, anhand derer der Hersteller von Strahlern die Sicherheit seiner Produkte im Gebrauch beurteilen kann und der Anwender der Strahler Typen auswählen kann, die für den jeweiligen Einsatz geeignet sind, insbesondere bezüglich des Schutzes vor einer möglichen Freisetzung ra-dioaktiven Materials und den daraus resultierenden Auswirkungen ionisierender Strahlung. Diese Internatio¬nale Norm kann auch als Leitlinie für Aufsichtsbehörden dienen.
Die Prüfungen sind in verschiedene Gruppen unterteilt, zu denen z. B. die Überprüfung der Auswirkungen ungewöhnlich hoher oder niedriger Temperaturen sowie eine Reihe mechanischer Prüfungen gehören. Jede Prüfung kann unter verschiedenen Graden der Beanspruchung ausgeführt werden. Die Erfüllung oder Nicht-erfüllung der Kriterien hängt von der Leckage von Inhaltsstoffen der Strahler ab.
ANMERKUNG   Dichtheitsprüfungen sind in ISO 9978 beschrieben.
Obgleich diese Norm Strahler nach verschiedenen Prüfungen klassifiziert, bedeutet dieses nicht, dass ein Strahler unversehrt bleibt, wenn er ständig den der angegebenen Klassifizierung entsprechenden Bedingun-gen ausgesetzt ist. Zum Beispiel kann ein für 1 h bei 600 °C geprüfter Strahler unversehrt bleiben oder auch nicht, wenn er ständig 600 °C ausgesetzt wird.
Eine Liste der typischen Hauptanwendungen von Strahlern mit einem empfohlenen Prüfplan für jede Anwen-dung ist in Tabelle 3 enthalten. Die Prüfungen entsprechen im weitesten Sinne den Minimalforderungen für die jeweiligen Anwendungen. Die für den Einsatz unter besonders schwierigen Bedingungen zu beachtenden Faktoren sind in 4.2 aufgeführt.
Mit dieser Internationalen Norm wird nicht beabsichtigt, die Gestaltung bzw. das Herstellungsverfahren sol¬cher Strahler oder deren Kalibrierung in Bezug auf die emittierte Strahlung festzulegen. Diese Internationale Norm gilt nicht für radioaktive Materialien im Innern von Kernreaktoren einschließlich dortiger umschlossener radioaktiver Stoffe und Brennelemente.

Radioprotection - Sources radioactives scellées - Exigences générales et classification (ISO 2919:2012)

Radiološka zaščita - Zaprti radioaktivni viri - Splošne zahteve in razvrstitev (ISO 2919:2012)

Ta mednarodni standard določa sistem razvrstitve za zaprte radioaktivne vire, ki temelji na preskusni učinkovitosti, ter določa splošne zahteve, preskuse učinkovitosti, proizvodne preskuse, označevanje in certificiranje. Zagotavlja sklop preskusov, s katerimi lahko proizvajalci zaprtih radioaktivnih virov ocenijo varnost svojih proizvodov med uporabo, uporabniki teh virov pa lahko izberejo tipe, ki so primerni za potrebno uporabo, zlasti pri zaščiti pred sproščanjem radioaktivnega materiala s posledično izpostavljenostjo ionizirajočemu sevanju. Ta mednarodni standard lahko služi tudi kot navodila za upravne organe. Preskusi spadajo v več skupin, kot so na primer izpostavljenost izredno visokim in nizkim temperaturam ter različni mehanski preskusi. Vsak preskus se lahko izvede različno strogo. Merila za uspešno/neuspešno opravljen preskus so odvisna od puščanja vsebine zaprtega radioaktivnega vira. OPOMBA: Preskusne metode za puščanje so navedene v standardu ISO 9978. Čeprav ta mednarodni standard razvršča zaprte vire z različnimi preskusi, ne zagotavlja, da bo zaprt vir ohranil svojo celovitost, če se trajno uporablja pri naznačeni razvrstitvi. Na primer, zaprt vir, ki se eno uro preskuša pri temperaturi 600 °C, lahko ohrani svojo celovitost, če se trajno uporablja pri 600 °C, ali pa tudi ne. Seznam glavnih običajnih uporab zaprtih radioaktivnih virov s predlaganim preskusnim razporedom za vsako uporabo je podan v preglednici 3. Preskusi predstavljajo minimalne zahteve, ki ustrezajo uporabam v najširšem smislu. Dejavniki, ki jih je treba upoštevati za uporabe v zlasti strogih pogojih, so navedene v točki 4.2. Ta mednarodni standard ne poskuša razvrstiti zasnove virov, njihove metode izdelave ali njihovega umerjanja v zvezi z oddanim sevanjem. Radioaktivni materiali v jedrskem reaktorju, vključno z zaprtimi viri in gorivnimi elementi, niso obravnavani v tem mednarodnem standardu.

General Information

Status
Published
Publication Date
04-Nov-2014
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
05-Nov-2014
Completion Date
05-Nov-2014

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SLOVENSKI STANDARD
SIST EN ISO 2919:2015
01-februar-2015

5DGLRORãND]DãþLWD=DSUWLUDGLRDNWLYQLYLUL6SORãQH]DKWHYHLQUD]YUVWLWHY ,62


Radiological protection - Sealed radioactive sources - General requirements and
classification (ISO 2919:2012)
Strahlenschutz - Umschlossene radioaktive Stoffe - Allgemeine Anforderungen und
Klassifikation (ISO 2919:2012) (ISO 2919:2012)

Radioprotection - Sources radioactives scellées - Exigences générales et classification

(ISO 2919:2012)
Ta slovenski standard je istoveten z: EN ISO 2919:2014
ICS:
13.280 Varstvo pred sevanjem Radiation protection
SIST EN ISO 2919:2015 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 2919:2015
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SIST EN ISO 2919:2015
EUROPEAN STANDARD
EN ISO 2919
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2014
ICS 13.280
English Version
Radiological protection - Sealed radioactive sources - General
requirements and classification (ISO 2919:2012)

Radioprotection - Sources radioactives scellées - Exigences Strahlenschutz - Umschlossene radioaktive Stoffe -

générales et classification (ISO 2919:2012) Allgemeine Anforderungen und Klassifikation (ISO

2919:2012)
This European Standard was approved by CEN on 25 October 2014.

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, 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

© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 2919:2014 E

worldwide for CEN national Members.
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SIST EN ISO 2919:2015
EN ISO 2919:2014 (E)
Contents Page

Foreword ..............................................................................................................................................................3

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SIST EN ISO 2919:2015
EN ISO 2919:2014 (E)
Foreword

The text of ISO 2919:2012 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 2919:2014 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 May 2015, and conflicting national standards shall be withdrawn at the

latest by May 2015.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent

rights. CEN [and/or CENELEC] 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Endorsement notice

The text of ISO 2919:2012 has been approved by CEN as EN ISO 2919:2014 without any modification.

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SIST EN ISO 2919:2015
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SIST EN ISO 2919:2015
INTERNATIONAL ISO
STANDARD 2919
Third edition
2012-02-15
Radiological protection — Sealed
radioactive sources — General
requirements and classification
Radioprotection — Sources radioactives scellées — Exigences
générales et classification
Reference number
ISO 2919:2012(E)
ISO 2012
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SIST EN ISO 2919:2015
ISO 2919:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,

electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s

member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved
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SIST EN ISO 2919:2015
ISO 2919:2012(E)
Contents Page

Foreword ............................................................................................................................................................................iv

Introduction ........................................................................................................................................................................ v

1 Scope ...................................................................................................................................................................... 1

2 Normative references ......................................................................................................................................... 1

3 Terms and definitions ......................................................................................................................................... 1

4 Designation and classification ........................................................................................................................ 3

4.1 Designation ........................................................................................................................................................... 3

4.2 Classification ........................................................................................................................................................ 3

4.3 Determination of classification ........................................................................................................................ 4

5 Activity level requirements ............................................................................................................................... 4

6 Performance requirements ............................................................................................................................... 5

6.1 General requirements ......................................................................................................................................... 5

6.2 Requirements for typical usage ...................................................................................................................... 5

6.3 Procedure for establishing classification and performance requirements ......................................... 6

6.4 Recommended working life (RWL) ................................................................................................................. 6

7 Test methods ........................................................................................................................................................ 7

7.1 General ................................................................................................................................................................... 7

7.2 Temperature test .................................................................................................................................................. 8

7.3 External pressure test ........................................................................................................................................ 9

7.4 Impact test ............................................................................................................................................................. 9

7.5 Vibration test ........................................................................................................................................................ 9

7.6 Puncture test ......................................................................................................................................................10

7.7 Bending tests .....................................................................................................................................................10

8 Source marking ..................................................................................................................................................12

9 Source certificate ..............................................................................................................................................12

10 Quality assurance .............................................................................................................................................13

Annex A (informative) Classification of radionuclides ...........................................................................................14

Annex B (informative) Example of certificate for sealed radioactive source ...................................................16

Annex C (informative) General information on adverse environmental conditions .......................................17

Annex D (informative) Additional tests .......................................................................................................................18

Bibliography .....................................................................................................................................................................19

© ISO 2012 – All rights reserved iii
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SIST EN ISO 2919:2015
ISO 2919:2012(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies

(ISO member bodies). The work of preparing International Standards is normally carried out through ISO

technical committees. Each member body interested in a subject for which a technical committee has been

established has the right to be represented on that committee. International organizations, governmental and

non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International

Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards

adopted by the technical committees are circulated to the member bodies for voting. Publication as an

International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent

rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 2919 was prepared by Technical Committee ISO/TC 85, Nuclear energy, nuclear technologies, and

radiological protection, Subcommittee SC 2, Radiological protection.

This third edition cancels and replaces the second edition (ISO 2919:1999), which has been technically revised.

iv © ISO 2012 – All rights reserved
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SIST EN ISO 2919:2015
ISO 2919:2012(E)
Introduction

Safety is the prime consideration when establishing standards about the use of sealed radioactive sources.

Sealed-source users have established an enviable record of safe usage as a result of careful scrutiny of the

conditions of application of the sealed radioactive source by the regulating authority, the supplier and the

user. However, as the application of sealed radioactive sources becomes more diversified and as regulating

agencies become more numerous, an International Standard is needed to specify the characteristics of a

sealed radioactive source and the essential performance and safety testing methods for a particular application

and, thus, maintain the record of safe usage.
© ISO 2012 – All rights reserved v
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SIST EN ISO 2919:2015
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SIST EN ISO 2919:2015
INTERNATIONAL STANDARD ISO 2919:2012(E)
Radiological protection — Sealed radioactive sources —
General requirements and classification
1 Scope

This International Standard establishes a classification system for sealed radioactive sources that is based

on test performance and specifies general requirements, performance tests, production tests, marking and

certification. It provides a set of tests by which manufacturers of sealed radioactive sources can evaluate the

safety of their products in use and users of such sources can select types which are suitable for the required

application, especially where protection against the release of radioactive material, with consequent exposure to

ionizing radiation, is concerned. This International Standard can also serve as guidance to regulating authorities.

The tests fall into several groups, including, for example, exposure to abnormally high and low temperatures

and a variety of mechanical tests. Each test can be applied in several degrees of severity. The criterion of pass

or fail depends on leakage of the contents of the sealed radioactive source.
NOTE Leakage test methods are given in ISO 9978.

Although this International Standard classifies sealed sources by a variety of tests, it does not imply that a

sealed source will maintain its integrity if used continuously at the rated classification. For example, a sealed

source tested for 1 h at 600 °C might, or might not, maintain its integrity if used continuously at 600 °C.

A list of the main typical applications of sealed radioactive sources, with a suggested test schedule for each

application, is given in Table 3. The tests constitute minimum requirements corresponding to the applications in

the broadest sense. Factors to be considered for applications in especially severe conditions are listed in 4.2.

This International Standard makes no attempt to classify the design of sources, their method of construction

or their calibration in terms of the radiation emitted. Radioactive materials inside a nuclear reactor, including

sealed sources and fuel elements, are not covered by this International Standard.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated

references, only the edition cited applies. For undated references, the latest edition of the referenced document

(including any amendments) applies.
ISO 361, Basic ionizing radiation symbol

ISO 9978:1992, Radiation protection — Sealed radioactive sources — Leakage test methods

3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
capsule
protective envelope used to prevent leakage of radioactive material
3.2
device
any piece of equipment designated to utilize one or several sealed sources
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SIST EN ISO 2919:2015
ISO 2919:2012(E)
3.3
dummy sealed source

facsimile of a sealed source, the capsule of which has the same construction and is made of exactly the same

materials as those of the sealed source it represents, but containing, in place of the radioactive material, a

substance resembling it as closely as is practical in physical and chemical properties

3.4
leachable

soluble in water, yielding quantities greater than 0,1 mg/g in 100 ml of still water maintained at 50 °C for 4 h

3.5
leakage

transfer of contained radioactive material from the sealed source to the environment

3.6
leaktight

having met the limiting values given in Table 1 of ISO 9978:1992 after leakage testing

3.7
model designation

manufacturer’s unique term (number, code or a combination of these) which is used to identify a specific design

of sealed source
3.8
non-leachable

insoluble in water, yielding quantities less than 0,1 mg/g in 100 ml of still water maintained at 50 °C for 4 h

3.9
prototype sealed source

original of a sealed source which serves as a pattern for the manufacture of all sealed sources identified by the

same model designation
3.10
sealed source

radioactive material sealed in a capsule or associated with a material to which it is closely bonded, this capsule

or bonding material being strong enough to maintain leaktightness of the sealed source under the conditions

of use and wear for which it was designed
3.11
test source

sample used in the performance tests described in this International Standard, having the same material and

construction as sealed sources of the model for which classification is being established

NOTE A test source may be a dummy sealed source, prototype or production source.
3.12
source assembly
sealed source contained within or attached to a source holder
3.13
source holder
mechanical device capable of retaining the sealed source
3.14
source in device

sealed source which remains within the shielded equipment during exposure, thus providing some mechanical

protection during use
3.15
unprotected source
sealed source which, for use, is removed from the shielding
2 © ISO 2012 – All rights reserved
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SIST EN ISO 2919:2015
ISO 2919:2012(E)
4 Designation and classification
4.1 Designation

The classification of the sealed source type shall be designated by the code ISO/, followed by two digits to

indicate the year of approval of the standard used to determine the classification, followed by a solidus (/),

followed by a letter, followed by five digits and a set of parentheses containing one or more digits.

The letter shall be either C or E:

— C indicates that the activity of the sealed source does not exceed the level specified in Table 2;

— E indicates that the activity of the sealed source exceeds the level specified in Table 2.

The five digits shall be the class numbers which describe the performances for temperature, external pressure,

impact, vibration and puncture respectively, in the order shown in Table 1.

If required, a number is inserted between the parentheses describing the type of bending test the source has

passed. Bending tests required for sources that have a particular shape (long slender sources, brachytherapy

needles) are listed in Table 1 and specific requirements are given in 7.7. Multiple tests may be performed and

described to satisfy the test criteria.
The parentheses may be omitted if no bending test is required.
EXAMPLES

— a typical industrial radiography source design for unprotected use would be designated “ISO/11/C43515(1)” or

“ISO/11/C43515”;
— a typical brachytherapy source design would be designated “ISO/11/C53211(8)”;
— a typical irradiator source design would be designated “ISO/11/E53424(4,7)”.
4.2 Classification

The classification levels are given in Table 1. Table 1 provides a list of environmental test conditions with class

numbers arranged in increasing order of severity. The performance requirements given in Table 3 do not

consider the effects of fire, explosion and corrosion.

In their evaluation of sealed sources, the manufacturer and user shall consider the probability of fire, explosion,

corrosion, etc. and the possible results from such events. Factors which should be considered when determining

the need for special testing are as follows:
a) consequences of loss of activity;
b) quantity of radioactive material contained in the sealed source;
c) radionuclide group;
d) chemical and physical form of the radioactive material;
e) environment in which the source is stored, moved and used;
f) protection afforded to the sealed source or source-device combination.

Annex C contains some general information on adverse environmental conditions. The user and manufacturer

should decide jointly on the additional tests, if any, to which the sealed source shall be subjected.

Annex D contains examples of special tests.
© ISO 2012 – All rights reserved 3
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SIST EN ISO 2919:2015
ISO 2919:2012(E)
Table 1 — Classification of sealed-source performance
Class
Test
1 2 3 4 5 6 7 8 X
Temperature No test -40 °C -40 °C -40 °C -40 °C -40 °C Not used Not used Special
(20 min) (20 min) (20 min) (20 min) (20 min) test
+80 °C +180 °C +400 °C +600 °C +800 °C
(1 h) (1 h) (1 h) and (1 h) and (1 h) and
thermal thermal thermal
shock to shock to shock to
20 °C 20 °C 20 °C
External No test 25 kPa 25 kPa 25 kPa 25 kPa 25 kPa Not used Not used Special
pressure absolute to absolute absolute absolute absolute test
atmos- to 2 MPa to 7 MPa to 70 MPa to 170 MPa
pheric absolute absolute absolute absolute

Impact No test 50 g from 200 g from 2 kg from 5 kg from 20 kg from Not used Not used Special

1 m or 1 m or 1 m or 1 m or 1 m or test
equivalent equivalent equivalent equivalent equivalent
imparted imparted imparted imparted imparted
energy energy energy energy energy

Vibration No test 3 times 3 times 3 times Not used Not used Not used Not used Special

10 min 10 min 30 min test
25 Hz to 25 Hz to 25 Hz to
500 Hz at 50 Hz at 80 Hz at
2 2
49 m/s 49 m/s 1,5 mm
a a
(5 g) (5 g) and peak to
50 Hz to peak and
90 Hz at 80 Hz to
0,635 mm 2 000 Hz
peak to at 196 m/s
peak and (20 g)
90 Hz to
500 Hz at
98 m/s
(10 g)

Puncture No test 1 g from 10 g from 50 g from 300 g from 1 kg from Not used Not used Special

1 m or 1 m or 1 m or 1 m or 1 m or test
equivalent equivalent equivalent equivalent equivalent
imparted imparted imparted imparted imparted
energy energy energy energy energy

Bending No test Test 7.7.1 Test 7.7.1 Test 7.7.1 Test 7.7.1 Test 7.7.1 Test 7.7.2 for Test 7.7.3 Special

100 N 500 N 1 000 N 2 000 N 4 000 N L > 100 mm for brachy- test
(10,2 kg) (51 kg) for (102 kg) for (204 kg) for (408 kg) for and for therapy
for L/D > 15 L/D > 15 L/D > 15 L/D > 15 L/D > 15 L/D > 10 needle
with
L > 30 mm
a 2
1 g = 9,8 m/s .
4.3 Determination of classification

The classification of each sealed source type shall be determined by one of the following methods:

— subjecting two test sources of that model to each test in Table 1, as described in Clause 7;

— engineering analysis which demonstrates that the sealed-source model would pass the tests of Clause 7

if these tests were performed.
5 Activity level requirements

The specified activity of sealed sources, below which a separate evaluation of the specific usage and design is

not required, is given in Table 2 for each of the four radionuclide groups defined in Annex A.

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SIST EN ISO 2919:2015
ISO 2919:2012(E)

Sealed sources containing more than the specified activity shall be subject to further evaluation of the specific

usage and design. For classification purposes, the activity level of a sealed source according to Table 2 shall

be considered at its time of manufacture.

Except if required, evaluation of the specific usage and design of the sealed source shall be considered only

when the activity of the principal radionuclide exceeds the value shown in Table 2. If the activity exceeds this

value, the specifications of the sealed sources shall be considered on an individual basis.

Table 2 — Specified activity according to radionuclide group
Radionuclide group Specified activity
(from Annex A) TBq (Ci)
Leachable Non-leachable
A 0,01 (0,3) 0,1 (3)
B1 1,11 (30) 11,1 (300)
B2 11,1 (300) 111 (3 000)
C 18,5 (500) 185 (5 000)
6 Performance requirements
6.1 General requirements

All sealed sources shall be tested after manufacture to ensure freedom from surface contamination. This shall

be done in accordance with one of the tests specified in 5.3 of ISO 9978:1992.

All sealed sources shall be tested after manufacture to ensure freedom from leakage. This shall be done in

accordance with one or more of the methods specified in ISO 9978.

Where feasible, the radiation output shall be established after manufacture. For some sources, this may not

be possible and a relative measurement against an agreed reference standard, or a statement of radioactive

content, may be substituted (e.g. beta emitters may be measured by ion current output or other methods).

The content activity of all sealed sources shall be estimated. This can be done from the result of the radiation

output measurement or from radioactive assay of the batch of material used in manufacture.

Test sealed sources shall be subjected, as specified herein, to the tests described in Clause 7. A classification

for the sealed-source model shall be given in accordance with Clause 4.

A certificate containing the results of tests on each sealed source shall be provided in accordance with

Clause 9.
Each sealed source shall be marked in accordance with Clause 8.

The sealed-source capsule shall be physically and chemically compatible with its contents. In the case of a

sealed source produced by direct irradiation, the capsule shall not contain significant quantities of radioactive

material unless that material is adequately bonded into the capsule material and radioactive test methods in

accordance with ISO 9978 show that the sealed source is leak-free.

The tracer in a test source shall be soluble in a solvent which does not attack the capsule and shall be safe to

137
use at maximum activity in a test environment (e.g. approximately 1 MBq Cs).
6.2 Requirements for typical usage

A list of some typical applications in which a sealed source, source assembly or source in device is used,

together with minimum performance requirements, is defined in Table 3.
One or more of the bending tests specified in 7.7 may also be required.
© ISO 2012 – All rights reserved 5
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SIST EN ISO 2919:2015
ISO 2919:2012(E)

For test sources where the ratio of active length (L) to minimum outer capsule diameter (D) is equal to or greater

than 15 (i.e. L/D ≥ 15), the bending tests required are those described in 7.7.1. For example, for sealed sources used

in category I irradiators, class 4 is required; for those used in categories II, III and IV irradiators, class 5 is required.

For test sources where the ratio of active length (L) to minimum outer capsule diameter (D) is 10 or greater (i.e.

L/D ≥ 10) and an active length equal to or greater than 100 mm (i.e. L ≥ 100 mm), the bending test required is

that described in 7.7.2 and is class 7.

For sealed sources in the form of brachytherapy needles having an active length (L) of equal to or greater than

30 mm (i.e. L ≥ 30 mm), the bending test required is that described in 7.7.3 and is class 8.

These requirements take into account normal usage and reasonable accidental risks, but do not include

exposure to fire, explosion or corrosion. For sealed sources normally mounted in devices, consideration is

given to the additional protection afforded to the sealed source by the device when the class number for a

particular usage was assigned. Thus, for all usages shown in Table 3, the class numbers specify the tests to

which the sealed source shall be subjected, except that for the ion generator category. For these, the complete

source assembly or source in device may be tested.

The tests specified herein do not cover all sealed-source usage situations. If the conditions of a particular

usage or the conditions relating to potential accidents do not match the classification specified in Table 3, the

manufacturer and user shall consider making appropriate tests on an individual basis.

The numbers shown in Table 3 refer to the class numbers used in Table 1.
6.3 Procedure for establishing classification and performance requirements
6.3.1 Establish the relevant radionuclide group from Annex A.
6.3.2 Determine the specified-activity value in accordance with Table 2.

6.3.3 An evaluation of hazards due to fire, explosion, corrosion, etc. shall be made for all sealed sources.

a) If the sealed-source activity exceeds the allowable level given in Table 2, or if there is a significant

probability of the source being exposed to fire, explosion and corrosion, a separate evaluation of the tests

required shall be made, which shall include source design and specific usage.
b) If the sealed-source activity does not exceed the allowable level given in
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