ISO/ASTM 51608:2015

Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 keV and 7.5 MeV

ISO/ASTM 51608:2015 outlines the dosimetric procedures to be followed during installation qualification, operational qualification, performance qualification and routine processing at an X-ray (bremsstrahlung) irradiator. Other procedures related to operational qualification, performance qualification and routine processing that may influence absorbed dose in the product are also discussed. ISO/ASTM 51608:2015 is one of a set of standards that provides recommendations for properly implementing and utilizing dosimetry in radiation processing. It is intended to be read in conjunction with ISO/ASTM Practice 52628, "Practice for Dosimetry in Radiation Processing". In contrast to monoenergetic gamma radiation, the X-ray energy spectrum extends from low values (about 35 keV) up to the maximum energy of the electrons incident on the X-ray target.

Practique de la dosimétrie dans une installation de traitement par des rayons X (bremsstrahlung) entre 50 KeV et 7,5 MeV

General Information

• Status: Published
• Publication Date: 16-Mar-2015
• ICS: 17.240 - Radiation measurements
• Technical Committee: ISO/TC 85 - Nuclear energy, nuclear technologies, and radiological protection
• Drafting Committee: ISO/TC 85 - Nuclear energy, nuclear technologies, and radiological protection
• Current Stage: 9599 - Withdrawal of International Standard
• Due Date: 04-Apr-2025
• Completion Date: 04-Apr-2025

Relations

• Revises: ISO/ASTM 51608:2005 - Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing
• Effective Date: 07-Jun-2014

Standards Content (Sample)

INTERNATIONAL ISO/ASTM
STANDARD 51608
Third edition
2015-03-15
Practice for dosimetry in an X-ray
(bremsstrahlung) facility for radiation
processing at energies between 50 KeV
and 7.5 MeV
Pratique de la dosimétrie dans une installation de traitement par
des rayons X (bremsstrahlung) entre 50 KeV et 7,5 MeV
Reference number
© ISO/ASTM International 2015
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe’s licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing.
In downloading this file, parties accept therein the responsibility of not infringing Adobe’s licensing policy. Neither the ISO Central
Secretariat nor ASTM International accepts any liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies
and ASTM members. In the unlikely event that a problem relating to it is found, please inform the ISO Central Secretariat or ASTM
International at the addresses given below.
© ISO/ASTM International 2015
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. In the United States, such requests should be sent to ASTM International.
ISO copyright office ASTM International,100 Barr Harbor Drive, PO Box C700,
Case postale 56 • CH-1211 Geneva 20 West Conshohocken, PA 19428-2959, USA
Tel. [phone] Tel. [phone]
Fax [phone] Fax [phone]
E-mail [e-mail] E-mail [e-mail]
Web www.iso.org Web www.astm.org
Published in Switzerland
ii © ISO/ASTM International 2015 – All rights reserved

Contents Page
1 Scope. 1
2 Referenced documents. 1
3 Terminology. 2
4 Significance and use. 3
5 Radiation source characteristics. 4
6 Types of facilities. 4
7 Selection and calibration of dosimetry system. 4
8 Process parameters. 4
9 Installation qualification. 5
10 Operational qualification. 5
11 Performance qualification. 7
12 Routine product processing. 8
13 Certification . 9
14 Measurement dose uncertainty and process variability . 10
15 Keywords. 10
Annex. 10
Figure A1.1 Beam current density distributions along the scan direction (wide curves) and
perpendiculartothescandirection(narrowcurves)ofNo.1acceleratorofJAERITakasaki(Fig.
2.1 from Ref (61)). 11
Figure A1.2 X-ray intensity per 2 MeV electron incident perpendicularly on a tantalum target
with thickness of one CSDA electron range as a function of emitting angle calculated by the
ETRAN code (Fig. 3.3 from Ref (61)). 11
Figure A1.3 X-ray intensity per 5 MeV electron incident perpendicularly on a tantalum target
withthicknessofoneCSDAelectronrangeasafunctionofemittinganglecalculatedbyETRAN
code (Fig 3.4 from Ref (61)). 11
Figure A1.4 X-ray emission rates from high-Z targets (Fig. E 1 from Ref (76)). 12
Figure A1.5 Spectrum of transmitted photons (Fig 2a from Ref (21)). 12
Figure A1.6 Spectrum of reflected photons (Fig. 2b from Ref (21)). 12
Figure A1.7 Depth dose distributions (Fig. 1 from Ref (9)). 12
Figure A1.8 Dose contour map, moving exposure (Fig. 3 from Ref (62)). 13
FigureA1.9 Measured attenuation curves for 5 MeV X-Rays in absorbers of various densities,
with moving conveyor and scanning beam (Fig. 5 from Ref (3)). 13
Figure A1.10 Measurement of a high-resolution attenuation curve for 5 MeV X-rays in the
heaviest absorber (chipboard) with moving conveyor and scanning (Fig. 6 from Ref (3)). 13
© ISO/ASTM International 2015 – All rights reserved iii

Foreword
ISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies
(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.
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.
ASTM International is one of the world’s largest voluntary standards development organizations with global
participation from affected stakeholders. ASTM technical committees follow rigorous due process balloting
procedures.
A project between ISO and ASTM International has been formed to develop and maintain a group of
ISO/ASTM radiation processing dosimetry standards. Under this project, ASTM Committee E61, Radiation
Processing, is responsible for the development and maintenance of these dosimetry standards with
unrestricted participation and input from appropriate ISO member bodies.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. Neither ISO nor ASTM International shall be held responsible for identifying any or all such patent
rights.
International Standard ISO/ASTM 51608 was developed by ASTM Committee E61, Radiation Processing,
through Subcommittee E61.03, Dosimetry Application, and by Technical Committee ISO/TC 85, Nuclear
energy, nuclear technologies and radiological protection.
This third edition cancels and replaces the second edition (ISO/ASTM 51608:2005), which has been
technically revised.
iv © ISO/ASTM International 2015 – All rights reserved

An American National Standard
Standard Practice for
Dosimetry in an X-Ray (Bremsstrahlung) Facility for
Radiation Processing at Energies between 50 keV and 7.5
MeV
This standard is issued under the fixed designation ISO/ASTM 51608; the number immediately following the designation indicates the
year of original adoption or, in the case of revision, the year of last revision.
1. Scope keV) up to the maximum energy of the electrons incident on
the X-ray target (see Section 5 and Annex A1).
1.1 This practice outlines the dosimetric procedures to be
followed during installation qualification, operational
1.6 Informationabouteffectiveorregulatorydoselimitsand
qualification, performance qualification and routine processing
energy limits for X-ray applications is not within the scope of
at an X-ray (bremsstrahlung) irradiator. Other procedures
this practice.
related to operational qualification, performance qualification
1.7 This standard does not purport to address all of the
androutineprocessingthatmayinfluenceabsorbeddoseinthe
safety concerns, if any, associated with its use. It is the
product are also discussed.
responsibility of the user of this standard to establish appro-
NOTE 1—Dosimetry is only one component of a total quality assurance
priate safety and health practices and determine the applica-
program for adherence to good manufacturing practices used in radiation
processing applications. bility of regulatory limitations prior to use.
NOTE 2—ISO/ASTM Practices 51649, 51818 and 51702 describe
dosimetric procedures for electron beam and gamma facilities for radia-
2. Referenced documents
tion processing.
2.1 ASTM Standards:
1.2 For radiation sterilization of health care products, see
E170Terminology Relating to Radiation Measurements and
ISO 11137-1, Sterilization of health care products – Radiation
Dosimetry
– Part 1: Requirements for development, validation and
E2232Guide for Selection and Use of Mathematical Meth-
routine control of a sterilization process for medical devices.In
ods for CalculatingAbsorbed Dose in Radiation Process-
those areas covered by ISO 11137-1, that standard takes
ing Applications
precedence.
E2303Guide for Absorbed-Dose Mapping in Radiation
1.3 Forirradiationoffood,seeISO14470, Food irradiation
Processing Facilities
– Requirements for development, validation and routine con-
2.2 ISO/ASTM Standards:
trol of the process of irradiation using ionizing radiation for
51261Practice for Calibration of Routine Dosimetry Sys-
the treatment of food. In those areas covered by ISO 14470,
tems for Radiation Processing
that standard takes precedence.
51539Guide for Use of Radiation-Sensitive Indicators
1.4 This document is one of a set of standards that provides
51649Practice for Dosimetry in an Electron Beam Facility
recommendations for properly implementing and utilizing
for Radiation Processing at Energies Between 300 keV
dosimetry in radiation processing. It is intended to be read in
and 25 MeV
conjunction with ISO/ASTM Practice 52628, “Practice for
51702Practice for Dosimetry in a Gamma Facility for
Dosimetry in Radiation Processing”.
Radiation Processing
51707Guide for Estimating Uncertainties in Dosimetry for
1.5 In contrast to monoenergetic gamma radiation, the
Radiation Processing
X-ray energy spectrum extends from low values (about 35
51818Practice for Dosimetry in an Electron Beam Facility
for Radiation Processing at Energies Between 80and 300
keV
This practice is under the jurisdiction of ASTM Committee E61 on Radiation
52628Practice for Dosimetry in Radiation Processing
Processing and is the direct responsibility of Subcommittee E61.03 on Dosimetry
Application, and is also under the jurisdiction of ISO/TC 85/WG 3.
Current edition approved Sept. 8, 2014. Published February 2015. Originally
published asASTM E 1608–94. Last previousASTM edition E 1608–00.ASTM E
1608–94 was adopted by ISO in 1998 with the intermediate designation ISO For referenced ASTM or ISO/ASTM standards, visit the ASTM website,
15567:1998(E). The present International Standard ISO/ASTM 51608:2015(E) is a www.astm.org, or contact ASTM Customer Service at [e-mail]. For
major revision of the last previous edition ISO/ASTM 51608:2005(E), which Annual Book of ASTM Standards volume information, refer to the standard’s
replaced ISO/ASTM 51608:2002(E). Document Summary page on the ASTM website.
© ISO/ASTM International 2015 – All rights reserved
52701Guide for Performance Characterization of Dosim- 3.1.3 beam width—dimension of the irradiation zone per-
etersandDosimetrySystemsforuseinRadiationProcess- pendiculartothedirectionofproductmovement,ataspecified
ing distance from the accelerator window.
3.1.3.1 Discussion—For graphic illustration, see ISO/
2.3 ISO Standards:
ASTM Practice 51649. This term usually applies to electron
ISO 11137-1Sterilization of health care products – Radia-
irradiation.
tion – Part 1: Requirements for development, validation
and routine control of a sterilization process for medical
3.1.4 bremsstrahlung—broad-spectrum electromagnetic ra-
devices
diation emitted when an energetic charged particle is influ-
ISO 14470 Food irradiation – Requirements for the
enced by a strong electric or magnetic field, such as that in the
development,validationandroutinecontroloftheprocess
vicinity of an atomic nucleus.
of irradiation using ionizing radiation for the treatment of
3.1.4.1 Discussion—In radiation processing, bremsstrahl-
food
ung photons with sufficient energy to cause ionization are
2.4 International Commission on Radiation Units and Mea- generated by the deceleration or deflection of energetic elec-
surements (ICRU) Reports: trons in a target material. When an electron passes close to an
ICRU Report 14Radiation Dosimetry: X Rays and Gamma atomicnucleus,thestrongcoulombfieldcausestheelectronto
RayswithMaximumPhotonEnergiesBetween0.6and50 deviate from its original motion. This interaction results in a
MeV loss of kinetic energy by the emission of electromagnetic
ICRU Report 34Dosimetry of Pulsed Radiation radiation.Suchenco
...