ISO/ASTM 51702:2013

Practice for dosimetry in a gamma facility for radiation processing

ISO/ASTM 51702:2013 outlines the installation qualification program for an irradiator and the dosimetric procedures to be followed during operational qualification, performance qualification, and routine processing in facilities that process products with ionizing radiation from radionuclide gamma sources to ensure that product has been treated within a predetermined range of absorbed dose. Other procedures related to operational qualification, performance qualification, and routine processing that may influence absorbed dose in the product are also discussed. NOTE 1 — Dosimetry is only one component of a total quality assurance program for adherence to good manufacturing practices used in radiation processing applications. NOTE 2 — ISO/ASTM Practices 51818 and 51649 describe dosimetric procedures for low and high enery electron beam facilities for radiation processing and ISO/ASTM Practice 51608 describes procedures for X-ray (bremsstrahlung) facilities for radiation processing.

Pratique de la dosimétrie dans les installations pour l'irradiation gamma

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: 9599 - Withdrawal of International Standard
• Due Date: 04-Apr-2025
• Completion Date: 04-Apr-2025

Relations

• Revises: ISO/ASTM 51702:2004 - Practice for dosimetry in a gamma irradiation facility for radiation processing
• Effective Date: 03-Dec-2011

Standards Content (Sample)

INTERNATIONAL ISO/ASTM
STANDARD 51702
Third edition
2013-04-15
Practice for dosimetry in a gamma
facility for radiation processing
Practique pour la dosimétrie dans les installations pour
l’irradiation gamma
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 Radiation source characteristics . 3
6 Types of facilities . 3
7 Dosimetry system calibration . 3
8 Installation qualification . 3
9 Operational qualification . 4
10 Performance qualification . 5
11 Routine product processing . 7
12 Certification . 7
13 Measurement uncertainty . 8
14 Keywords . 8
Bibliography . 8
© 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,
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 51702 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.
iv © ISO/ASTM International 2013 – All rights reserved

An American National Standard
Standard Practice for
Dosimetry in a Gamma Facility for Radiation Processing
This standard is issued under the fixed designation ISO/ASTM 51702; 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 E2303 Guide for Absorbed-Dose Mapping in Radiation
Processing Facilities
1.1 This practice outlines the installation qualification pro-
E2628 Practice for Dosimetry in Radiation Processing
gram for an irradiator and the dosimetric procedures to be
E2701 Guide for Performance Characterization of Dosim-
followed during operational qualification, performance quali-
eters and Dosimetry Systems for Use in Radiation Process-
fication, and routine processing in facilities that process prod-
ing
ucts with ionizing radiation from radionuclide gamma sources
2.2 ISO/ASTM Standards:
to ensure that product has been treated within a predetermined
51261 Practice for Calibration of Routine Dosimetry Sys-
rangeofabsorbeddose.Otherproceduresrelatedtooperational
tems for Radiation Processing
qualification, performance qualification, and routine process-
51539 Guide for Use of Radiation-Sensitive Indicators
ing that may influence absorbed dose in the product are also
51608 Practice for Dosimetry in an X-Ray (Bremsstrahl-
discussed.
ung) Facility for Radiation Processing
NOTE 1—Dosimetry is only one component of a total quality assurance
51649 Practice for Dosimetry in an Electron Beam Facility
program for adherence to good manufacturing practices used in radiation
for Radiation Processing at Energies Between 300 KeV
processing applications.
and 25 KeV
NOTE 2—ISO/ASTM Practices 51818 and 51649 describe dosimetric
51707 Guide for Estimating Uncertainties in Dosimetry for
procedures for low and high enery electron beam facilities for radiation
processing and ISO/ASTM Practice 51608 describes procedures for X-ray Radiation Processing
(bremsstrahlung) facilities for radiation processing.
51818 Practice for Dosimetry in an Electron Beam Facility
for Radiation Processing at Energies Between 80 and 300
1.2 For the radiation sterilization of health care products,
keV
see ISO 11137-1. In those areas covered by ISO 11137-1, that
2.3 International Commission on Radiation Units and
standard takes precedence.
Measurements (ICRU) Reports:
1.3 This document is one of a set of standards that provides
ICRU Report 85a Fundamental Quantities and Units for
recommendations for properly implementing and utilizing
Ionizing Radiation
dosimetry in radiation processing. It is intended to be read in
2.4 ISO Standards:
conjunction with ASTM Practice E2628.
ISO 11137-1 Sterilization of health care products – Radia-
1.4 This standard does not purport to address all of the
tion – Part 1: Requirements for development, validation,
safety concerns, if any, associated with its use. It is the
and routine control of a sterilization process for medical
responsibility of the user of this standard to establish appro-
devices
priate safety and health practices and determine the applica-
2.5 Joint Committee for Guides in Metrology (JCGM)
bility of regulatory limitations prior to use.
Reports:
2. Referenced documents
JCGM 100:2008, GUM 1995, with minor corrections,
Evaluation of measurement data – Guide to the Expres-
2.1 ASTM Standards:
sion of Uncertainty in Measurement
E170 TerminologyRelatingtoRadiationMeasurementsand
Dosimetry
3. Terminology
E2232 Guide for Selection and Use of Mathematical Meth-
3.1 Definitions:
odsforCalculatingAbsorbedDoseinRadiationProcessing
3.1.1 absorbed dose, D—quantity of ionizing radiation
Applications
energy imparted per unit mass of a specified material. The SI
unit of absorbed dose is the gray (Gy), where 1 gray is
This practice is under the jurisdiction of ASTM Committee E61 on Radiation
equivalent to the absorption of 1 joule per kilogram of the
Processing and is the direct responsibility of Subcommittee E61.03 on Dosimetry
specified material (1 Gy = 1 J/kg). The mathematical relation-
Application, and is also under the jurisdiction of ISO/TC 85/WG 3.
ship is the quotient of d´¯ by dm, where d´¯ is the mean
Current edition approved Dec. 26, 2012. Published April 2013. Originally
published as E 1702-95. Last previous ASTM edition E 1702–00. ASTM
ϵ1
E 1702–95 was adopted by ISO in 1998 with the intermediate designation ISO
15571:1998(E). The present International Standard ISO/ASTM 51702:2013(E) Available from the International Commission on Radiation Units and Measure-
replaces ISO 15571 and is a major revision of the last previous edition ISO/ASTM ments, 7910 Woodmont Ave., Suite 800, Bethesda, MD 20814, USA.
51702–2004(E). Available from International Organization for Standardization (ISO), 1 rue de
For referenced ASTM and ISO/ASTM standards, visit the ASTM website, Varembé, Case postale 56, CH-1211, Geneva 20, Switzerland, http://www.iso.ch.
www.astm.org, or contact ASTM Customer Service at [e-mail]. For Document produced by Working Group 1 of the Joint Committee for Guides in
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
incremental energy imparted by ionizing radiation to matter of 3.1.14.1 Discussion—For a shuffle-dwell irradiator the
incremental mass dm (see ICRU Report 85a). timer setting is the time interval from the start of one
shuffle-dwell cycle to the start of the next shuffle-dwell cycle.
D 5 d´¯/dm (1)
For a stationary irradiator, the timer setting is the total
3.1.2 absorbed-dose mapping—measurement of absorbed
irradiation time.
dose within an irradiation product to produce a one-, two- or
3.2 Definitions of other terms used in this standard that
three-dimensionaldistributionofabsorbeddose,thusrendering
pertain to radiation measurement and dosimetry may be found
a map of absorbed-dose values.
in ASTM Terminology E170. Definitions in E170 are compat-
3.1.3 calibration curve—expression of the relation between
ible with ICRU Report 85a; ICRU Report 85a, therefore, may
indication and corresponding measured quantity value.
be used as an alternative reference.
3.1.3.1 Discussion—In radiation processing standards, the
term “dosimeter response” is generally used for “indication.”
4. Significance and use
3.1.4 compensating dummy—See simulated product.
4.1 Various products and materials routinely are irradiated
3.1.5 dosimeter response—reproducible, quantifiable radia-
at predetermined doses in gamma irradiation facilities to
tion effect produced in the dosimeter by ionizing radiation.
reduce their microbial population or to modify their character-
3.1.6 dosimeter set—one or more dosimeters used to mea-
istics. Dosimetry requirements may vary depending upon the
suretheabsorbeddoseatalocationandwhoseaveragereading
irradiation application and end use of the product. Some
is used as the absorbed-dose measurement at that location.
examples of irradiation applications where dosimetry may be
3.1.7 dosimetry system—system used for absorbed dose,
used are:
consisting of dosimeters, measurement instruments and their
4.1.1 Sterilization of medical devices,
associatedreferencestandards,andproceduresforthesystem’s
4.1.2 Treatment of food for the purpose of parasite and
use.
pathogen control, insect disinfestation, and shelf life extension,
3.1.8 installation qualification (IQ)—process of obtaining
4.1.3 Disinfection of consumer products,
and documenting evidence that equipment has been provided
4.1.4 Cross-linking or degradation of polymers and elasto-
and installed in accordance with specifications.
mers,
3.1.9 irradiation container—holder in which product is
4.1.5 Polymerization of monomers and grafting of mono-
placed during the irradiation process.
mers onto polymers,
3.1.9.1 Discussion—“Irradiationcontainer”isoftenreferred
4.1.6 Enhancement of color in gemstones and other mate-
tosimplyas“container”andcanbeacarrier,cart,tray,product
rials,
carton, pallet, product package or other holder.
4.1.7 Modification of characteristics of semiconductor de-
3.1.10 operational qualification (OQ)—process of obtain-
vices, and
ing and documenting evidence that installed equipment oper-
4.1.8 Research on materials effects.
ates within predetermined limits when used in accordance with
its operati
...