ISO/ASTM 51400:2002

Practice for characterization and performance of a high-dose radiation dosimetry calibration laboratory

ISO/ASTM 15400 describes the characterization and performance criteria to be met by a high-dose radiation dosimetry calibration laboratory. By meeting these criteria, the laboratory may be accredited by a recognized accreditation organization. Adherence to these criteria will ensure high standards of performance and instill confidence that the accredited laboratory is competent to provide reliable, accurate services.

Pratique de caractérisation et d'exploitation d'un laboratoire d'étalonnage de dosimétrie d'irradiations à hautes doses

General Information

• Status: Withdrawn
• Publication Date: 17-Apr-2002
• Withdrawal Date: 17-Apr-2002
• 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
• Completion Date: 18-Aug-2003

Relations

• Revised: ISO/ASTM 51400:2003 - Practice for characterization and performance of a high-dose radiation dosimetry calibration laboratory
• Effective Date: 15-Apr-2008
• Revises: ISO 15560:1998 - Practice for characterization and performance of a high-dose radiation dosimetry calibration laboratory
• Effective Date: 15-Apr-2008

Standards Content (Sample)

INTERNATIONAL ISO/ASTM
STANDARD 51400
First edition
2002-03-15
Practice for characterization and
performance of a high-dose radiation
dosimetry calibration laboratory
Pratique de caractérisation et d’exploitation d’un laboratoire
d’étalonnage de dosimétrie d’irradiations à hautes doses
Reference number
ISO/ASTM 51400:2002(E)
© ISO/ASTM International 2002

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ISO/ASTM 51400:2002(E)
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ISO/ASTM 51400:2002(E)
Contents Page
1 Scope . 1
2 Referenced documents . 1
3 Terminology . 1
4 Significance and use . 2
5 General criteria . 2
6 Specific criteria for ionizing radiation . 6
7 Specific criteria for calibrations using photons and electrons . 8
8 Measurement uncertainty . 9
9 Keywords . 9
ANNEX . 9
Bibliography . 10
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ISO/ASTM 51400:2002(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.
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 Subcommittee E10.01,
Dosimetry for 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 International Standard 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 51400 was developed by ASTM Committee E10, Nuclear Technology and
Applications, through Subcommittee E10.01, and by Technical Committee ISO/TC 85, Nuclear Energy.
Annex A1 of this International Standard is for information only.
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ISO/ASTM 51400:2002(E)
Standard Practice for
Characterization and Performance of a High-Dose Radiation
1
Dosimetry Calibration Laboratory
This standard is issued under the fixed designation ISO/ASTM 51400; 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 3. Terminology
1.1 This practice contains the characterization and perfor- 3.1 Descriptions of Terms Specific to This Standard:
mance criteria to be met by a high-dose radiation dosimetry 3.1.1 accuracy goals—the maximum acceptable deviation
calibration laboratory. By meeting these criteria, the laboratory from the accepted reference value of a measured quantity,
may be accredited by a recognized accreditation organization. where the accepted reference value is defined by the appropri-
Adherence to these criteria will ensure high standards of ate national standard.
performance and instill confidence that the accredited labora- 3.1.2 calibration—the process whereby the response of a
tory is competent to provide reliable, accurate services. dosimeter or measuring instrument is characterized through
comparison with an appropriate standard that is traceable to,
2. Referenced Documents
and consistent with, a national standard.
2.1 ASTM Standards: 3.1.2.1 Discussion—The types of dosimeters include refer-
E 170 Terminology Relating to Radiation Measurements
ence–standard dosimeters, transfer–standard dosimeters, and
2
and Dosimetry routine dosimeters. See ISO/ASTM Guide 51261 for guidance
E 177 Practice for Use of the Terms Precision and Bias in
on the selection and calibration of the various dosimetry
3
ASTM Test Methods systems.
3
E 456 Terminology Relating to Quality and Statistics
3.1.3 dosimetry system—a system used for determining
E 1249 Practice for Minimizing Dosimetry Errors in Radia-
absorbed dose, consisting of dosimeters, measurement instru-
tion Hardness Testing of Silicon Electronic Devices Using ments and their associated reference standards, and procedures
2
Co-60 Sources
for the system’s use.
E 1250 Test Method for Application of Ionization Cham- 3.1.4 laboratory—high-dose calibration laboratory that in-
bers to Assess the Low Energy Gamma Component of
cludes pertinent radiation calibration facilities, services, per-
Cobalt-60 Irradiators Used in Radiation-Hardness Testing sonnel, and equipment.
2
of Silicon Electronic Devices
3.1.5 laboratory accreditation—formal recognition that a
2.2 ISO/ASTM Standards: laboratory is competent to carry out specific calibrations in
51261 Guide for Selection and Calibration of Dosimetry
accordance with documented requirements of a recognized
2
Systems for Radiation Processing accrediting organization.
51707 Guide for Estimating Uncertainties in Dosimetry for
3.1.6 measurement quality assurance plan—a documented
2
Radiation Processing program for the measurement process that quantifies, on a
2.3 International Organization for Standardization Docu-
continuing basis, the overall uncertainty of the measurements.
ments: This plan requires traceability to and consistency with national
ISO/IEC Guide 25 (1990) General Requirements for the
or international standards, and shall ensure that the overall
4
Competence of Calibration and Testing Laboratories uncertainty meets the requirements of the specific application.
ISO 9002 Quality Systems— Model for Quality Assurance
3.1.7 measurement traceability—the ability to demonstrate
4
in Production, Installation, and Servicing and document periodically that the measurement results from a
particular measurement system are in agreement with compa-
rable measurement results obtained with a national standard (or
1
This practice is under the jurisdiction of ASTM Committee E10 on Nuclear
some identifiable and accepted standard) to a specified uncer-
Technology and Applications and is the direct responsibility of Subcommittee
E10.01 on Dosimetry for Radiation Processing, and is also under the jurisdiction of tainty.
ISO/TC 85/WG 3.
3.1.8 primary–standard dosimeter—a dosimeter of the
Current edition approved Jan. 22, 2002. Published March 15, 2002. Originally
highest metrological quality, established and maintained as an
e1
published as ASTM E 1400 – 91. Last previous ASTM edition E 1400 – 95a .
e1
absorbed dose standard by a national or international standards
ASTM E 1400 – 95a was adopted by ISO in 1998 with the intermediate designa-
tion ISO 15560:1998(E). The present International Standard ISO/ASTM
organization.
51400:2002(E) is a revision of ISO 15560.
3.1.9 proficiency testing—evaluation of the measurement
2
Annual Book of ASTM Standards, Vol 12.02.
3 capability of a calibration laboratory and demonstration of
Annual Book of ASTM Standards, Vol 14.02.
4
consistency with appropriate national standards.
Available from International Organization for Standardization, 1 Rue de
Varembé, Case Postale 56, CH–1211 Geneva 20, Switzerland.
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ISO/ASTM 51400:2002(E)
3.1.10 quality assurance—all systematic actions necessary operational requirements of this practice; (2) documented
to provide adequate confidence that a calibration or measure- procedures and in-house quality assurance (QA) program
ment is performed to a predefined level of quality. specific to the calibration services provided; and (3) periodic
3.1.11 quality control—the operational techniques and pro- performance evaluations, including proficiency tests and on-
5
cedures that are employed routinely to achieve and sustain a site expert assessments. (1,2)
predefined level of quality. 4.3 When a potential calibration laboratory applies for
3.1.12 quality manual—document stating the quality policy, accreditation, the accrediting organization (see Annex A1)
quality system, and quality practices of an organization. determines whether the laboratory’s quality documentation is
3.1.13 quality system—organizational structure, responsi- satisfactory, performs proficiency tests for each calibration
bilities, procedures, processes, and resources for implementing category for which accreditation is requested, and provides
quality management. technical experts for on-site assessments to determine whether
3.1.14 radiation processing—the intentional irradiation of the laboratory meets the criteria of this practice.
products or materials to preserve, modify, or improve their 4.4 Section 5 sets forth general criteria that shall be satisfied
characteristics. by each laboratory seeking accreditation. These general criteria
3.1.15 recognized accreditation organization— organiza- are completely consistent with ISO/IEC Guide 25. Laborato-
tion, operating in conformance with national regulations or ries that meet these general requirements comply, for calibra-
requirements, that conducts and administers a laboratory ac- tion activities, with Guide 25 and the relevant requirements of
creditation program and grants accreditation to calibration the ISO 9000 series of standards, including those of the model
laboratories. described in ISO 9002 when they are acting as suppliers
3.1.16 reference–standard dosimeter—a dosimeter of high producing calibration results.
metrological quality used as a standard to provide measure- 4.5 For laboratories engaged in specific fields of calibration,
ments traceable to, and consistent with, measurements made the general requirements of ISO/IEC Guide 25 need amplifi-
using primary–standard dosimeters. cation and interpretation. Section 6 of this practice contains
3.1.17 routine dosimeter—a dosimeter calibrated against a specific criteria which provide that amplification and interpre-
primary-, reference-, or transfer-standard dosimeter and used tation for ionizing radiation. Section 7 contains specific criteria
for routine absorbed dose measurement. for particular types of ionizing radiation, that is, gamma rays,
3.1.18 transfer–standard dosimeter—a dosimeter, often a electron beams and X-ray (bremsstrahlung) beams.
reference–standard dosimeter, suitable for transport between 4.6 For ease of use, all sections of this document after
different locations for use as an intermediary to compare Section 5 employ the format established in Section 5. It is
absorbed dose measurements. therefore readily apparent how the subsequent sections amplify
3.1.19 verification—confirmation by examination of objec- and interpret the general requirements contained in Section 5.
tive evidence that specified requirements have been met.
5. General Criteria
3.1.19.1 Discussion—In the case of measuring equipment,
the result of verification leads to a decision either to restore to
5.1 This section sets forth the general requirements that
service or to perform adjustments, or to repair, or to down- shall be satisfied by each laboratory seeking accreditation. In
grade, or to declare obsolete. In all cases it is required that a
addition to satisfying the general criteria of this section, a
written trace of the verification performed be kept on the laboratory shall also satisfy the specific criteria contained in
instrument’s individual record.
Section 6 and in those parts of Section 7 relevant to each
3.1.20 working standard—a standard, usually calibrated calibration service for which accreditation is sought (see 4.4
against a reference standard, used routinely to calibrate or
and 4.5).
check measuring instruments or devices. 5.2 This section may also be used by calibration laboratories
3.2 Also see ASTM Terminology E 170.
in the development and implementation of their quality sys-
tems, and by others concerned with evaluating the competence
4. Significance and Use
of laboratories.
4.1 The radiation industry needs a source of reliable, prompt
5.3 Organization and Management:
dosimeter calibration services to support accurate measure-
5.3.1 The laboratory shall be organized and shall operate in
ments of absorbed dose during radiation processing. Those
such a way that its facilities meet the requirements of this
measurements, made routinely in industrial facilities, should be
section.
consistent with and traceable to the physical measurement
5.3.2 The laboratory shall:
standards maintained by an appropriate national or interna-
5.3.2.1 Have managerial staff with the authority and re-
tional standards laboratory. Organizations that might provide
sources needed to discharge their duties,
calibration services and thereby serve as a link to national
5.3.2.2 Have arrangements to ensure that its personnel are
standards include universities, government-owned laborato-
free from any commercial, financial, and other conflicts which
ries, and private companies.
might adversely affect the quality of their work,
4.2 To ensure the provision of adequate services, a calibra-
tion laboratory should be operating with a full measurement
5
quality assurance (MQA) program. The fundamental require-
The boldface numbers in parentheses refer to the bibliography at the end of this
practice.
ments for such a program include: (1) compliance with
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ISO/ASTM 51400:2002(E)
5.3.2.3 Be organized in such a way that confidence in its 5.4.2.7 The laboratory’s procedures for achieving traceabil-
independence of judgement and integrity is maintained at all ity of measurements,
times,
5.4.2.8 The laboratory’s scope of calibrations,
5.3.2.4 Specify and document the responsibility, authority,
5.4.2.9 Arrangements for ensuring that the laboratory re-
and interrelation of all personnel who manage, perform, or
views all new work to ensure that it has the appropriate
verify work affecting the quality of calibrations,
facilities and resources before commencing such work,
5.3.2.5 Provide adequate supervision by persons familiar
5.4.2.10 Reference to the calibration and verification proce-
with the calibration methods and procedures, the objective of
dures used,
the calibration, and the assessment of the results,
5.4.2.11 Procedures for handling calibration and test items,
5.3.2.6 Have a technical manager (however named) who has
5.4.2.12 Reference to the major equipment and reference
overall responsibility for the technical operations,
measurement standards used,
5.3.2.7 Have a quality manager (however named) who has
5.4.2.13 Reference to procedures for calibration, verifica-
responsibility for the quality system and its implementation.
tion, and maintenance of equipment,
The quality manager shall have direct access to the highest
5.4.2.14 Reference to verification practices including inter-
level of management at which decisions are made on calibra-
laboratory comparisons, proficiency testing programs, use of
tion laboratory policy or resources, and to the technical
reference materials, and internal quality control schemes,
manager. In some laboratories, the quality manager may also
5.4.2.15 Procedures to be followed for consultation and
be the technical manager or deputy technical manager of the
corrective action whenever discrepancies in proficiency testing
calibration laboratory,
are detected or departures from documented policies and
5.3.2.8 Nominate deputies in case of absence of the techni-
procedures occur,
cal or quality manager,
5.4.2.16 The laboratory management arrangements for ex-
5.3.2.9 Where relevant, have documented policy and proce-
ceptionally permitted departures from documented policies and
dures to ensure the protection of clients’ confidential informa-
procedures or from standard specifications,
tion and proprietary rights, and
5.4.2.17 Procedures for dealing with complaints,
5.3.2.10 Where appropriate, participate in interlaboratory
5.4.2.18 Procedures for protecting confidentiality and pro-
comparisons and proficiency testing programs.
prietary rights, and
5.4 Quality System, Audit, and Review:
5.4.2.19 Procedures for audit and review.
5.4.1 The laboratory shall establish and maintain a quality
5.4.3 The laboratory shall arrange for audits of its activities
system appropriate to the type, range, and volume of calibra-
at appropriate intervals to verify that its operations continue to
tion activities it undertakes. The elements of this system shall
comply with the requirements of the quality system. Such
be documented. The quality documentation shall be available
audits shall be carried out by trained and qualified staff who
for use by the laboratory personnel. The laboratory shall define
are, wherever possible, independent of the activity to be
and document its policies and objectives for, and its commit-
audited. Where the audit findings cast doubt on the correctness
ment to, good laboratory practice and quality of calibration
or validity of the laboratory’s calibration results, the laboratory
services. The laboratory management shall ensure that these
shall take corrective action and shall notify, in writing, as soon
policies and objectives are documented in a quality manual and
as practically possible, any client whose work may have been
communicated to, understood, and implemented by all labora-
affected.
tory personnel concerned. The quality manual shall be main-
5.4.4 The quality system adopted to satisfy the requirements
tained current under the responsibility of the quality manager.
of this section shall be reviewed at least once a year by the
5.4.2 The quality manual, and related quality documenta-
management to ensure its continuing suitability and effective-
tion, shall state the laboratory’s policies and operational
ness and to introduce any necessary changes or improvements.
procedures established in order to meet the requirements of this
Any changes in the quality system shall be approved by the
section. The quality manual and related quality documentation
accrediting organization prior to implementation.
shall also contain:
5.4.5 All audit and review findings and any corrective
5.4.2.1 A quality policy statement, including objectives and
commitments, by top management, actions that arise from them shall be documented. The person
responsible for quality shall ensure that these actions are
5.4.2.2 The organization and management structure of the
discharged within the agreed time scale.
laboratory, its place in any parent organization, and relevant
organizational charts, 5.4.6 In addition to periodic audits the laboratory shall
5.4.2.3 The relations between management, technical opera- ensure the quality of results provided to clients by implement-
ing and documenting checks. These checks shall be reviewed
tions, support services, and the quality system,
by management and shall include, as appropriate, but not be
5.4.2.4 Procedures for control and maintenance of docu-
limited to:
mentation,
5.4.2.5 Job descriptions of key staff and reference to the job 5.4.6.1 Internal quality control schemes using, whenever
practical, statistical techniques,
descriptions of other staff,
5.4.2.6 Identification of the laboratory’s approved signato- 5.4.6.2 Participation in proficiency testing or other inter-
ries, laboratory comparisons,
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ISO/ASTM 51400:2002(E)
5.4.6.3 Replicate calibrations using the same or different 5.7.4.1 The name of the item of equipment,
methods, and
5.7.4.2 The manufacturer’s name, type identification, and
5.4.6.4 Re-calibration of retained instruments and dosim- serial number or other unique identification,
eters. 5.7.4.3 The date received and the date placed in service,
5.5 Personnel: 5.7.4.4 The current location, where appropriate,
5.5.1 The laboratory shall have sufficient personnel having 5.7.4.5 The condition when received (for example, new,
the necessary education, training, technical knowledge, and
used, reconditioned),
experience to carry out their assigned functions.
5.7.4.6 A copy of the manufacturer’s instructions, where
5.5.2 The laboratory shall ensure that the training of its
available,
personnel is kept up-to-date (see Section 6).
5.7.4.7 The dates and results of calibrations or verifications,
5.5.3 Records on the relevant qualifications, training, skills, or both, and the date of the next calibration or verification, or
and experience of the technical personnel shall be maintained
both,
by the laboratory.
5.7.4.8 The name and signature of the person who per-
5.6 Facilities and Environment: formed the calibrations or verifications, or both,
5.6.1 Laboratory facilities including calibration areas, elec- 5.7.4.9 The details of maintenance carried out to date and
trical power sources, lighting, heating, and ventilation shall be
planned for the future, and
adequate to facilitate proper performance of calibrations.
5.7.4.10 The history of any damage, malfunction, modifi-
5.6.2 The environment in which calibrations and related cation, or repair.
activities are undertaken shall not invalidate the results or
5.8 Measurement Traceability and Calibration:
compromise the specified uncertainty of measurement.
5.8.1 All measuring equipment having an effect on the
5.6.3 The laboratory shall provide facilities for the effective
accuracy or validity of calibrations shall be calibrated or
monitoring, control, and recording of environmental conditions
verified, or both, before being put into service. The laboratory
as appropriate. Due attention shall be paid, for example, to
shall have an established program for the calibration and
dust, electromagnetic interference, humidity, electrical power
verification of its measuring equipment. (3)
stability, temperature, and sound and vibration levels, as
5.8.2 The overall program of calibration or verification, or
appropriate to the calibrations performed.
both, and validation of equipment shall be designed and
5.6.4 The laboratory design shall provide adequate protec-
operated so as to ensure that, wherever applicable, measure-
tion between areas where the activities are incompatible.
ments made by the laboratory are traceable to national or
5.6.5 Access to and use of all areas affecting the quality of
international standards of measurement where available. Cali-
calibration and related activities shall be defined and con- bration certificates shall, wherever applicable, indicate the
trolled.
traceability to national standards of measurement, and shall
5.6.6 Adequate measures shall be taken to ensure good provide the measurement results and associated uncertainty of
housekeeping. measurement or a statement of compliance, or both, with an
identified metrological specification.
5.6.7 The laboratory shall comply with all relevant health
and safety requirements. 5.8.3 Where traceability to national or international stan-
5.7 Equipment: dards of measurement is either not available or not applicable,
the laboratory shall provide satisfactory evidence of correlation
5.7.1 The laboratory shall be furnished with all items of
of results, for example by participation in a suitable program of
equipment required for the correct performance of calibrations.
interlaboratory comparisons or proficiency testing.
In those cases where the laboratory needs to use equipment
5.8.4 Reference standards of measurement held by the
outside its permanent control, it shall ensure that the relevant
requirements of this section are met. laboratory shall be used for calibration only and for no other
purpose, unless it can be demonstrated that use for other
5.7.2 All equipment shall be properly maintained. Mainte-
purposes will not invalidate their performance as reference
nance procedures shall be documented. Any item of equipment
standards.
which has been subjected to overloading or mishandling, or
5.8.5 Reference standards of measurement shall be cali-
which gives suspect results, or has been shown by verification
brated by a body that can provide traceability to a national or
or during calibration or use to be defective, shall be taken out
international standard of measurement. There shall be a pro-
of service, clearly identified, and wherever possible stored at a
gram of calibration and verification for reference standards.
specified place until it has been repaired and shown by
calibration, verification, or test to perform satisfactorily. The 5.8.6 Where relevant, reference standards and measuring
laboratory shall examine the effect of this defect on previous equipment shall be subjected to in-service checks (constancy
calibrations. checks) between calibrations and verifications.
5.7.3 Each item of equipment shall, when appropriate, be 5.9 Calibration Methods:
labelled, marked, or otherwise identified to indicate its calibra-
5.9.1 The laboratory shall have documented instructions for
tion status.
using and operating all relevant equipment, for handling and
5.7.4 Records shall be maintained for each item of equip- preparing dosimeters, and for performing calibrations, where
ment significant to the calibrations performed. The records the absence of such instructions could jeopardize the calibra-
shall include: tions. All instructions, standards, manuals, and reference data
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ISO/ASTM 51400:2002(E)
relevant to the work of the laboratory shall be maintained preparation, or whether the client requires the laboratory to
up-to-date and be readily available to the staff. perform or arrange for such preparations.
5.9.2 The laboratory shall use appropriate methods and 5.10.3 The laboratory shall have documented procedures
procedures for all calibrations and related activities within its and appropriate facilities to avoid deterioration or damage to
responsibility (including handling, transport, storage, and the dosimeters during storage, handling, preparation, and
preparation of dosimeters, estimation of uncertainty of mea- calibration; any relevant instructions provided with the dosim-
surement, and analysis of calibration data)(4,5). The methods eter shall
...