The Standards
Cycle and
Conformity Testing
Peter Chiaro
Oak Ridge National Laboratory
ORNL is managed by UT-Battelle
for the US Department of Energy
Agenda
• Define types of standards
• Describe standards process – development,
publication, use, revision
• Conformity or Conformance Testing
• Other topics of interest
– IEC SC45B and TC104
2 The Standards Cycle and Conformity Testing
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Standards Types – Horizontal/Crosscutting
• Basis and Use
– Establish overall performance
requirements for electrotechnical
devices
– Used by device and test equipment
manufacturers, testing organizations,
and product standards developers
• Drivers
– Operating environments
– Testing capabilities
– Functional expectations
3 The Standards Cycle and Conformity Testing
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Horizontal/Crosscutting Standards Examples
• 60721-3-2, Classification Of Environmental Conditions – Part 3: Classification of groups of
environmental parameters and their severities – Section 2: Transportation and Handling
–
Classifies the groups of environmental parameters and their severities to which a product is subjected
while being transported and handled
• 60068-2-1, Environmental testing – Part 2-1: Tests – Test A: Cold
–
Establishes cold test processes for both non heat-dissipating and heat-dissipating specimens
• 60068-2-2, Part 2: Tests – Tests B: Dry heat
–
Establishes dry heat test processes for both non heat-dissipating and heat-dissipating specimens
• 61000-4-3, Electromagnetic compatibility (EMC) – Part 4-3: Testing and measurement techniques
– Radiated, radio-frequency, electromagnetic field immunity test
–
Establishes test levels and procedures related to ensuring that electrical and electronic equipment are
immune to radiated electromagnetic energy
• 62706, Radiation protection instrumentation – Environmental, electromagnetic and mechanical
performance requirements
–
Defines what is required in the design of radiation instrumentation and the performance requirements and
test methods related to the expected environments during use
4 The Standards Cycle and Conformity Testing
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Standards Types – Product/Process
• Basis and Use
– Establish functional performance requirements for specific
classifications of electrotechnical devices
– Used by device manufacturers, testing organizations,
device users, and procurement professionals
• Drivers
– Users/Consumers desires and needs
– Government or organizational requirements
– Technology
5 The Standards Cycle and Conformity Testing
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Product/Process Standards Examples
• IEC 62618, Radiation protection instrumentation – Spectroscopy-based alarming Personal
Radiation Detectors (SPRD) for the detection of illicit trafficking of radioactive material
–
Establish performance requirements, provide examples of acceptable test methods, and to specify general
functional characteristics and test conditions
• IEC 62484, Radiation protection instrumentation – Spectroscopy-based portal monitors used for
the detection and identification of illicit trafficking of radioactive material
–
Specifies the detection and radionuclide identification performance requirements and test methods for the
applicable devices
• ANSI N42.43, American National Standard Performance Criteria for Mobile and Transportable
Radiation Monitors Used for Homeland Security
–
Specifies the performance requirements and tests for radiation monitors that are designed to be
transported to a location and used for a specific detection task or for a specified period of time, or are
mounted to a vehicle such as a trailer.
• ISO 22188, Monitoring for inadvertent movement and illicit trafficking of radioactive material
–
Specifies methods and means of monitoring for inadvertent movement and illicit trafficking of radioactive
material providing guidelines on the use of stationary and portable instruments to monitor for radiation
signatures from radioactive material.
6 The Standards Cycle and Conformity Testing
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Standards Process
• Need for standard identified
– For IEC, new work proposal developed by potential leader and
provided for international review
– Approval obtained based on need, interest, and availability of
leaders and experts
• Draft Phase (initial draft)
– Draft document developed
– Review existing performance data
– Review existing usage data
• Coordination Phase (committee draft to committee draft
for review – CD to CDV)
– CD is internal to writing committee
– CD moves to CDV when committee considers the standard to
be technically complete
• Depending on the results of the international review, a CDV can move
forward directly to publication
7 The Standards Cycle and Conformity Testing
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7
Standards Process – continued
• Validation
– Applicable devices tested against selected sections of the
standard to verify standard makes sense and secondarily,
to determine/ensure standard is achievable
– Step not implemented globally
• Publication phase (Final Draft International
Standard – FDIS)
– Ballot or final review
• Publication
– Enters selected (e.g., 3-y) maintenance cycle
8 The Standards Cycle and Conformity Testing
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8
Standards Process - Revision
• Initiated by:
–
–
–
–
Technology status – has there been any changes?
Conformity test results
User needs
Time
• If revision is needed, start at Draft Phase with the
understanding that a standard exists
–
–
–
–
Draft Phase
Coordination
Validation
Publication
9 The Standards Cycle and Conformity Testing
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Conformity Testing
• Definition
– Testing that determines whether a device complies with
the requirements of a specification, contract or regulation
– Testing to a standard
• Provides
– Independent results regarding the performance of a
device against a known criteria
• Availability
– Accredited testing facilities
– Specialized test sites
10 The Standards Cycle and Conformity Testing
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Conformity Testing Process
• Identify requirements
– Standard(s)
– Procurement/acquisition requirements
– Establish critical requirements - “shalls” and “shoulds”
• Determine test location
– Accredited
– Qualified
• Establish data needs
• Perform testing
• Analyze results
• Provide report
11 The Standards Cycle and Conformity Testing
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Conformity Testing and Standards
• Provides actual performance results against the
standard
• Identifies limitations and inconsistencies within a
standard
• Provides feedback to the standards community
• Helps to ensure standards remain current
• Helps to ensure reality of requirements
12 The Standards Cycle and Conformity Testing
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Conformity Testing vs Operational Testing
• Conformity testing
– Verifies conformance to a standard or other available set of
requirements, including environmental requirements
– Performed by accredited or qualified testing organization
– Typically shareable results
– Identifies baseline functionality
– Provides direct feedback as to relevance of applicable
standard
• Operational testing
– Verifies functionality against user-based operational needs
• Sometimes standards-based test method – examples to follow
– Performed by users
– Does not typically involve controlled environmental testing
– Provides indirect feedback to the standards community
13 The Standards Cycle and Conformity Testing
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Operations-Based Test Methods
Examples – Mobile Detection Systems
• Slowly approaching source—monitor is stationary
during use
– Requirements
• The monitor shall indicate when the ambient radiation background
has increased to a level that is too high for it to operate as
required, such as what may occur as a result of a slowly
approaching radiation source.
– Test method
• Position a 137Cs source at a distance to ensure that the source
does not affect the ambient background at the monitor.
• Start moving the source towards and through the middle of the
detection zone at the selected speed.
• If the monitor alarms or indicates that the background has
changed, the trial can be considered complete and the source can
be returned to the starting point.
14 The Standards Cycle and Conformity Testing
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Operations-Based Test Methods
Examples – Mobile Detection Systems
• Background effects—monitor is mobile during use
– Requirements and background information
• Mobile monitors shall function normally when exposed to changing
background situations that may be encountered during normal use.
• Test method basis:
– Measurements using different detection technologies in urban, suburban, and rural
areas.
– Vehicle driven at posted speed limits and at controlled speeds.
– Test method
• Background change only
– With the monitor operating as it would during use (e.g., scanning), increase the count
rate using the artificial background source over a time period of 30 seconds.
– Background reduced following stabilization period.
– No alarms should be activated or identification of radionuclides other than those used
for the artificial background source should occur during the process.
• Background change with additional source
– Midway through each 30 second background change and without stopping, perform a
dynamic test using 137Cs.
– The monitor shall alarm for each trial when exposed to the 137Cs.
15 The Standards Cycle and Conformity Testing
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Increasing Background With Source
16 The Standards Cycle and Conformity Testing
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Decreasing Background With Source
17 The Standards Cycle and Conformity Testing
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Obtaining Accreditation – U.S.
• Obtained via the National Voluntary Laboratory
Accreditation Program – NVLAP
– IEC/ISO 17025, “General requirements for the
competence of testing and calibration laboratories”
• Accreditation based on the applicable ANSI
standard
– Testing organization identifies the standard(s) and
individual step(s) within each standard they wish to be
accredited to perform
– Not required to be accredited to the entire standard
• Registration fees and assessment visit costs are
covered by the requesting facility
18 The Standards Cycle and Conformity Testing
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Accreditation Status – U.S.
• Three facilities are accredited in the U.S.
– Oak Ridge National Laboratory (all standards, nearly all
sections)
– Pacific Northwest National Laboratory
– Savanah River National Laboratory
• Additional information available at –
– https://wwws.nist.gov/niws/index.cfm?event=directory.results
– Search on “Homeland Security Applications” – “Radiation
Detection Instruments”
19 The Standards Cycle and Conformity Testing
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Before Moving On…..
Questions? Comments?
20 The Standards Cycle and Conformity Testing
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Other Topics of Interest
• Sub Committee 45B
• Technical Committee 104
21 The Standards Cycle and Conformity Testing
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SC45B Radiation Protection Instrumentation
• Prepare standards that address instrumentation used for:
– the measurement of ionizing radiation in the workplace, to the public, and in the
environment for radiation protection purposes;
– illicit trafficking detection and identification of radionuclides;
– radiation-based security screening.
• Country membership
– Participating countries (P-members): 21
– Observer countries (O-members): 14
• More than 100 experts from the world leading
–
–
–
–
Testing laboratories
Governmental agencies
Manufacturers
Users
• Publications in force
– Issued: 56+
– Projects in development: 9
• Liaisons with ISO, IAEA, ICRP, ICRU…
22 The Standards Cycle and Conformity Testing
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IEC/SC 45B Structure
Officers – Peter Chiaro, Chair / Miroslav Voytchev, Secretary
• WG 5 - Measurement of Environmental
Radiation
– Andrew Nicholas Tyler, GB
• WG 16 - Contamination meters and
monitors
– Akira Yunoki, JP
• WG 8 - Active pocket and portable dose
(rate) meters and monitors and passive
dosimetry systems (absorbed 14)
– Rolf Behrens, DE
• WG 17 - Security inspection systems
using active interrogation with radiation
– Lawrence T Hudson, US
• WG 9 - Installed Equipment for
Radiation and Activity Monitoring in
Nuclear Facilities
– Robin T. Pearce, GB
• WG 10 - Radon and Radon Decay
Products Measuring Instruments
– Giuliano Sciocchetti, IT
• WG 15 - Illicit Trafficking Control
Instrumentation
– Leticia Pibida, US
23 The Standards Cycle and Conformity Testing
• PT 62461 - Determination of uncertainty
in measurement
– Rolf Behrens, DE
• PT 62957-1 – RASE
– Mikhail Mayorov and Lucy Ooi,
IAEA and US
• PT TR 62971 – Radiation sources used
in illicit trafficking detection standards
– Peter Chiaro – Published
PTs are disbanded following publication
UNCLASSIFIED
SC45B Work Scope
Working
Group
Project Leader
Forecast
Publication Date
CDIS - 2015APUB - 2015-11
09
WG 8
J. Rotunda
2016-01
IEC 61017 Ed. 1.0
Radiation protection instrumentation - Transportable, mobile or
CDIS - 2015installed equipment to measure photon radiation for environmental
APUB - 2015-12
10
monitoring
WG 5
T. Nakamura
2016-02
IEC 61322 Ed. 2.0
Radiation protection instrumentation - Installed dose equivalent rate
1CD - 2015meters, warning assemblies and monitors for neutron radiation of
A2CD - 2016-03
11
energy from thermal to 15 MeV
WG 9
T. Nakamura
2019-06
IEC 61563 Ed. 2.0
Radiation protection instrumentation - Equipment for measuring
specific activity of gamma-emitting radionuclides in foodstuffs
2CD - 2015A3CD - 2016-03
11
WG 16
A. Yunoki
2016-09
IEC 62327 Ed. 2.0
Radiation protection instrumentation - Hand-held instruments
for the detection and identification of radionuclides and for the 3CD - 2015A4CD - 2016-02
estimation of ambient dose equivalent rate from photon
10
radiation
WG 15
P. Chiaro
2017-06
IEC 62401 Ed. 2.0
Radiation protection instrumentation - Alarming Personal
Radiation Devices (PRD) for detection of illicit trafficking of
radioactive material
3CD - 2015A4CD - 2016-03
10
WG 15
M. Voytchev
2017-06
IEC 62945 Ed. 1.0
Radiation protection instrumentation - Measuring the imaging
performance of X-ray Computed Tomography (CT) security
screening systems
1CD - 2015A2CD - 2016-03
11
PT 62945
L. Hudson
2017-08
Radiation instrumentation - Semi-empirical method for
performance evaluation of detection and radionuclide
IEC 62957-1 Ed. 1.0 identification - Part 1: Performance evaluation of the
instruments, featuring radionuclide identification in static
mode
1CD - 2015A2CD - 2015-05
02
PT 62957-1
L. Ooi/M.
Mayorov
2017-10
IEC 62963 Ed. 1.0
Bottle/can liquid X-ray inspection system
ANW - 20141CD - 2015-10
11
WG 17
Kejun Kang
2018-02
PNW/TS 45B-832
Ed. 1.0
Radiation protection instrumentation - Dosemeters for pulsed fields PNW - 2015ANW - 2016-04
of ionizing radiation
11
WG 8
H. Zutz
2018-12
Project Reference
Current
Stage
Title
Radiation protection instrumentation - Ambient and/or directional
dose equivalent (rate) meters and/or monitors for beta, X and
IEC 60846-2 Ed. 2.0 gamma radiation - Part 2: High range beta and photon dose and
dose rate portable instruments for emergency radiation protection
purposes
UNCLASSIFIED
Next Stage
IEC Standards
• TC 104 - Environmental conditions, classification
and methods of test
25 The Standards Cycle and Conformity Testing
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Scope
• Standardization of environmental condition classes which
represent the conditions to which products are most likely to
be subjected whilst being:
– transported,
– stored,
– installed and used.
The classification shall use validated environmental parameters and
provide guidance in the selection and use of those classes intended for
the preparation of relevant specifications.
• Standardization of environmental test methods intended for
the preparation of relevant specifications and to provide
guidance in the selection and use of those methods.
• Correlation and transformation of environmental condition
classes to environmental tests.
26 The Standards Cycle and Conformity Testing
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Structure
• WG 14 Climatic field data including validation
• WG 15 Dynamic field data including validation
• Maintenance Teams
–
–
–
–
MT 16 Climatic conditions and tests
MT 17 Dynamic Conditions and tests
MT 18 Special cases
MT 19 Maintenance of IEC 60721-3 series
27 The Standards Cycle and Conformity Testing
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TC104 Work Program
Project Reference
Title
Current Stage
Next Stage
Working
Group
Project Leader
Forecast
Publication Date
IEC 60068-2-18
Environmental testing - Part 2-18: Tests
- Test R and guidance: Water
1CD - 2015-03
A2CD - 2015-07
MT 18
O. Nevalainen
2017-11
IEC 60068-2-39
Environmental testing - Part 2-39: Tests
and Guidance: Combined temperature
or temperature and humidity with low air
pressure tests
CDIS - 2015-06
APUB - 2015-08
MT16
(Chiaro)
Klaus Raabe
2015-10
IEC 60068-2-52
Environmental testing - Part 2: Tests Test Kb: Salt mist, cyclic (sodium,
chloride solution)
1CD - 2015-01
A2CD - 2015-05
MT16
(Chiaro)
S. Suga
2017-11
IEC 60721-2-4
Classification of environmental
conditions - Part 2-4: Environmental
conditions appearing in nature - Solar
radiation and temperature
1CD - 2015-01
A2CD - 2015-05
MT16
(Chiaro)
K. Raabe
2017-11
IEC 60721-3-0
Classification of environmental
conditions - Part 3: Classification of
groups of environmental parameters
and their severities. Introduction
1CD - 2015-01
A2CD - 2015-05
MT 19
(Chiaro)
P.J. Chiaro Jr
2015-12
IEC 60721-3-1
Classification of environmental
conditions - Part 3: Classification of
groups of environmental parameters
and their severities - Section 1: Storage
1CD - 2015-01
A2CD - 2015-05
MT 19
(Chiaro)
P.J. Chiaro Jr
2015-12
IEC 60721-3-2
Classification of environmental
conditions - Part 3: Classification of
groups of environmental parameters
and their severities - Section 2:
Transportation
1CD - 2015-02
A2CD - 2015-06
MT 19
(Chiaro)
P.J. Chiaro Jr
2015-12
PNW 104-629
Time history replication
PNW - 2013-11
ANW - 2014-03
MT 17
K. Ahlin
PNW 104-658
Environmental testing- Part 2-xx: Rapid
change of dew condensation
PNW - 2015-08
ANW - 2015-12
UNCLASSIFIED
T. Ishida
Activities of Interest
• 60068 series are the most common standards in use. Other TC104
standards are primarily background material.
• IEC 60068-2-18, Water
– All instrument standards use splash or rain
– Initial review indicated no change required
• IEC 60068-2-52, Salt mist
– May affect processes used when performing salt fog/mist testing
• IEC 60721-3-1, Classification of Storage
– Most likely not of great concern, but may be valuable when doing a procurement
for larger items.
• IEC 60721-3-2, Classification of transportation
– Need to be aware of possible changes to existing vibration or shock spectra
29 The Standards Cycle and Conformity Testing
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Questions? Comments?
30 The Standards Cycle and Conformity Testing
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Backup Slides
31 The Standards Cycle and Conformity Testing
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IEC RID - 62327
• First revision
• Originally published 2006
• Goals
–
–
–
–
Update performance requirements where needed
Remove confused sections on detection and localization
Be consistent to the extent possible with ANSI N42.34
Focus on performance requirements
• View standard and newer technique
• View comparison table
32 The Standards Cycle and Conformity Testing
UNCLASSIFIED
IEC Source Guide – TR 62971
• Radiation instrumentation - Radiation sources used in illicit
trafficking detection standards - Guidance and recommendations
– Provides guidance and recommendations regarding the availability and
use of radiation sources that are needed when testing and evaluating
instruments used for the detection of illicit trafficking of radioactive
material.
– Guidance includes the use of surrogate or replacement radioactive
materials that could be more easily obtained.
– The object of this TR is to provide guidance to instrument manufacturers
and users, and testing organizations as to the selection and possible use
of radiation sources, surrogates and source simulation tools.
• At publication stage
• View latest version
33 The Standards Cycle and Conformity Testing
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IEC 62957: Semi-empirical method for
performance evaluation of detection
and radionuclide identification
• aka - RASE
• Led by Lucy Ooi of DNDO and Mikhail Mayorov of the IAEA
• Part 1: Performance evaluation of the instruments, featuring
radionuclide identification in static mode
– Specifies requirements for data preparation and data injection when
using the semi-empirical method for performance evaluation of
detection and radionuclide identification
– Recommends approaches for results interpretation and consolidation
and establishes a method to share data and analysis results.
– Specific to the performance evaluation of radionuclide identification in
static mode, i.e., when measurement geometry does not change (e.g.
radionuclide identification devices in start-stop mode).
• CDV stage
34 The Standards Cycle and Conformity Testing
UNCLASSIFIED