ISO/ASTM 51261:2013

Practice for calibration of routine dosimetry systems for radiation processing

ISO/ASTM 51261:2013 specifies the requirements for calibrating routine dosimetry systems for use in radiation processing, including establishing measurement traceability and estimating uncertainty in the measured dose using the calibrated dosimetry system. NOTE 1 — Regulations or other directives exist in many countries that govern certain radiation processing applications such as sterilization of healthcare products and radiation processing of food requiring that absorbed-dose measurements be traceable to national or international standards (ISO 11137-1, Refs (1-3)2).

Pratique d'étalonnage des appareils de mesure dosimétrique routinier pour le traitement par irradiation

General Information

• Status: Published
• Publication Date: 21-Mar-2013
• 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: 9560 - Close of voting
• Start Date: 02-Jan-2025
• Due Date: 03-Jan-2025
• Completion Date: 03-Jan-2025

Relations

• Consolidated By: ISO 2417:2016 - Leather — Physical and mechanical tests — Determination of the static absorption of water
• Effective Date: 06-Jun-2022
• Revises: ISO/ASTM 51261:2002 - Guide for selection and calibration of dosimetry systems for radiation processing
• Effective Date: 06-Aug-2011

Standards Content (Sample)

INTERNATIONAL ISO/ASTM
STANDARD 51261
Second edition
2013-04-15
Practice for calibration of routine
dosimetry systems for radiation
processing
Practique d’étalonnage des appareils de mesure dosimétrique
routinier pour le traitement par irradiation
Reference number
© ISO/ASTM International 2013
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ii © ISO/ASTM International 2013 – All rights reserved

Contents Page
1 Scope . 1
2 Referenced documents . 1
3 Terminology . 1
4 Significance and use . 2
5 Dosimeter system calibration overview . 3
6 Requirements for a routine dosimetry system calibration . 3
7 Requirements for measurement instruments calibration and performance verification . 3
8 Requirements for the sampling of calibration dosimeters . 4
9 Calibration of dosimetry systems . 4
10 Minimum documentation requirements . 6
11 Keywords . 6
Annexes . 7
Bibliography . 18
© ISO/ASTM International 2013 – 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 pilot project between ISO and ASTM International has been formed to develop and maintain a group of
ISO/ASTM radiation processing dosimetry standards. Under this pilot project, ASTM Committee E61,
RadiationProcessing,isresponsibleforthedevelopmentandmaintenanceofthesedosimetrystandardswith
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 51261 was developed by ASTM Committee E61, Radiation Processing,
through Subcommittee E61.01, Dosimetry, and by Technical Committee ISO/TC 85, Nuclear energy, nuclear
technologies and radiological protection.
iv © ISO/ASTM International 2013 – All rights reserved

An American National Standard
Standard Practice for
Calibration of Routine Dosimetry Systems for Radiation
Processing
This standard is issued under the fixed designation ISO/ASTM 51261; 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 E178 Practice for Dealing With Outlying Observations
E2628 Practice for Dosimetry in Radiation Processing
1.1 This practice specifies the requirements for calibrating
E2701 Guide for Performance Characterization of Dosim-
routine dosimetry systems for use in radiation processing,
etersandDosimetrySystemsforUseinRadiationProcess-
includingestablishingmeasurementtraceabilityandestimating
ing
uncertainty in the measured dose using the calibrated dosim-
2.2 ISO/ASTM Standards:
etry system.
51607 Practice for Use of an Alanine-EPR Dosimetry Sys-
NOTE 1—Regulations or other directives exist in many countries that
tem
govern certain radiation processing applications such as sterilization of
51707 Guide for Estimating Uncertainties in Dosimetry for
healthcare products and radiation processing of food requiring that
Radiation Processing
absorbed-dose measurements be traceable to national or international
2.3 International Commission on Radiation Units and
standards (ISO11137-1, Refs (1-3) ).
Measurements Reports:
1.2 The absorbed-dose range covered is up to 1 MGy.
ICRU Report 85a Fundamental Quantities and Units for
1.3 The radiation types covered are photons and electrons
Ionizing Radiation
with energies from 80 keV to 25 MeV.
2.4 ISO Standards:
1.4 This document is one of a set of standards that provides
ISO 11137-1 Sterilization of health care products—
recommendations for properly implementing dosimetry in
Radiation—Requirements for the development, validation
radiation processing, and describes a means of achieving
and routine control of a sterilization process for medical
compliance with the requirements of ASTM E2628 “Practice
devices
for Dosimetry in Radiation Processing” for the calibration of
2.5 ISO/IEC Standards:
routinedosimetrysystems.Itisintendedtobereadinconjunc-
17025 GeneralRequirementsfortheCompetenceofTesting
tion withASTM E2628 and the relevantASTM or ISO/ASTM
and Calibration Laboratories
standard practice for the dosimetry system being calibrated
2.6 Joint Committee for Guides in Metrology (JCGM)
referenced in Section 2.
Reports:
1.5 This standard does not purport to address all of the
JCGM 100:2008, GUM 1995, with minor corrections,
safety concerns, if any, associated with its use. It is the
Evaluation of measurement data – Guide to the Expres-
responsibility of the user of this standard to establish appro-
sion of Uncertainty in Measurement
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
3. Terminology
3.1 Definitions:
2. Referenced documents
3.1.1 approved laboratory—laboratory that is a recognized
2.1 ASTM Standards:
nationalmetrologyinstitute;orhasbeenformallyaccreditedto
E170 TerminologyRelatingtoRadiationMeasurementsand
ISO/IEC 17025; or has a quality system consistent with the
Dosimetry
requirements of ISO/IEC 17025.
3.1.1.1 Discussion—Arecognized national metrology insti-
tute or other calibration laboratory accredited to ISO/IEC
This guide is under the jurisdiction of ASTM Committee E61 on Radiation
Processing and is the direct responsibility of Subcommittee E61.01 on Dosimetry,
17025 should be used in order to ensure traceability to a
and is also under the jurisdiction of ISO/TC 85/WG 3.
national or international standard. A calibration certificate
Current edition approved Aug. 16, 2012. Published April 2013. Originally
published asASTM E1261–88. Last previousASTM edition E1261–00.ASTM
ϵ1
E 1261–94 was adopted by ISO in 1998 with the intermediate designation ISO
15556:1998(E). The present International Standard ISO/ASTM 51261:2013(E) is a Available from International Commission on Radiation Units and Measure-
major revision of ISO/ASTM 51261:2002(E), which replaced ISO 15556. ments, 7910 Woodmont Avenue, Suite 800, Bethesda, MD 20814, USA.
2 5
The boldface numbers given in parentheses refer to the bibliography at the end Available from International Organization for Standardization (ISO), 1, ch. de
of this guide. la Voie-Creuse, Case postale 56, CH-1211, Geneva 20, Switzerland, http://
For referenced ASTM and ISO/ASTM standards, visit the ASTM website, www.iso.ch.
www.astm.org, or contact ASTM Customer Service at [e-mail]. For DocumentproducedbyWorkingGroup1oftheJointCommitteeforGuidesin
Annual Book of ASTM Standards volume information, refer to the standard’s Metrology (JCGM/WG 1). Available free of charge at the BIPM website (http://
Document Summary page on the ASTM website. www.bipm.org).
© ISO/ASTM International 2013 – All rights reserved
provided by a laboratory not having formal recognition or for routine absorbed dose measurements, including dose map-
accreditation will not necessarily be proof of traceability to a ping and process monitoring.
national or international standard. 3.1.16 traceability—propertyoftheresultofameasurement
or the value of a standard whereby it can be related to stated
3.1.2 calibration—set of operations that establish, under
references, usually national or international standards, through
specified conditions, the relationship between values of quan-
an unbroken chain of comparisons all having stated uncertain-
tities indicated by a measuring instrument or measuring sys-
ties.
tem,orvaluesrepresentedbyamaterialmeasureorareference
3.1.16.1 Discussion—Measurementtraceabilityisarequire-
material, and the corresponding values realized by standards.
ment of any measurement management system (see Annex
3.1.3 calibration curve—expression of the relation between
A4).
indication and the corresponding measured quantity value.
3.1.17 transfer standard dosimetry system—dosimetry sys-
3.1.4 charged-particle equilibrium (referred to as electron
tem used as an intermediary to calibrate other dosimetry
equilibrium in the case of electrons set in motion by photon
systems.
beamirradiationofamaterial)—conditioninwhichthekinetic
3.1.18 type I dosimeter—dosimeter of high metrological
energy of charged particles (or electrons), excluding rest mass,
quality, the response of which is affected by individual influ-
entering an infinitesimal volume of the irradiated material
ence quantities in a well-defined way that can be expressed in
equals the kinetic energy of charged particles (or electrons)
terms of independent correction factors.
emerging from it.
3.1.19 type II dosimeter—dosimeter, the response of which
3.1.5 dosimeter batch—quantity of dosimeters made from a
isaffectedbyinfluencequantitiesinacomplexwaythatcannot
specific mass of material with uniform composition, fabricated
practically be expressed in terms of independent correction
in a single production run under controlled, consistent condi-
factors.
tions, and having a unique identification code.
3.1.20 uncertainty (of measurement)—parameter associated
3.1.6 dosimeter stock—partofadosimeterbatchheldbythe
with the result of a measurement that characterizes the disper-
user.
sion of the values that could reasonably be attributed to the
3.1.7 dosimetry system—system used for measuring ab-
measurand or derived quantity.
sorbed dose, consisting of dosimeters, measurement instru-
3.1.21 uncertainty budget—quantitative analysis of the
ments and their associated reference standards, and procedures
component terms contributing to the uncertainty of a measure-
for the system’s use.
ment, including their statistical distribution, mathematical
3.1.8 electron equilibrium—charged particle equilibrium
manipulation and summation.
for electrons. (See charged-particle equilibrium.)
3.2 validation (of a process)—establishmentofdocumented
3.1.9 influence quantity—quantity that is not the measurand
evidence, which provides a high degree of assurance that a
but that affects the result of the measurement. specified process will consistently produce a product meeting
its predetermined specifications and quality attributes.
3.1.10 in-situ/in-plant calibration—calibration where the
3.3 verification—confirmation by examination of objective
dosimeter irradiation is performed in the place of use of the
routine dosimeters. evidence that specified requirements have been met.
3.3.1 Discussion—In the case of measuring equipment, the
3.1.10.1 Discussion—In-situ/in-plant calibration of dosim-
result of verification leads to a decision either to restore to
etry systems refers to irradiation of dosimeters along with
service or to perform adjustments, repair, downgrade, or
reference or transfer standard dosimeters, under operating
declare obsolete. In all cases it is req
...