The Standards Cycle and Conformity Testing · 2016. 6. 3. · Peter Chiaro Oak Ridge National Laboratory . 2 The Standards Cycle and Conformity Testing UNCLASSIFIED Agenda •Define

ORNL is managed by UT-Battelle

for the US Department of Energy

The Standards

Cycle and

Conformity Testing

Peter Chiaro

Oak Ridge National Laboratory

2 The Standards Cycle and Conformity Testing UNCLASSIFIED

Agenda

• Define types of standards

• Describe standards process – development, publication, use, revision

• Conformity or Conformance Testing

• Other topics of interest

– IEC SC45B and TC104


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


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


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


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.


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


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


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


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


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


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


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


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.


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.


Increasing Background With Source


Decreasing Background With Source


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


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://www-s.nist.gov/niws/index.cfm?event=directory.results

– Search on “Homeland Security Applications” – “Radiation Detection Instruments”

https://www-s.nist.gov/niws/index.cfm?event=directory.results




Before Moving On…..

Questions? Comments?


Other Topics of Interest

• Sub Committee 45B

• Technical Committee 104


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…


IEC/SC 45B Structure

• WG 5 - Measurement of Environmental Radiation

– Andrew Nicholas Tyler, GB

• WG 8 - Active pocket and portable dose (rate) meters and monitors and passive dosimetry systems (absorbed 14)

– Rolf Behrens, DE

• 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

• WG 16 - Contamination meters and monitors

– Akira Yunoki, JP

• WG 17 - Security inspection systems using active interrogation with radiation

– Lawrence T Hudson, US

• 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

Officers – Peter Chiaro, Chair / Miroslav Voytchev, Secretary

SC45B Work Scope

Project Reference Title Current

Stage Next Stage

Working

Group Project Leader

Forecast

Publication Date

IEC 60846-2 Ed. 2.0

Radiation protection instrumentation - Ambient and/or directional

dose equivalent (rate) meters and/or monitors for beta, X and

gamma radiation - Part 2: High range beta and photon dose and

dose rate portable instruments for emergency radiation protection

purposes

CDIS - 2015-

09 APUB - 2015-11 WG 8 J. Rotunda 2016-01

IEC 61017 Ed. 1.0

Radiation protection instrumentation - Transportable, mobile or

installed equipment to measure photon radiation for environmental

monitoring

CDIS - 2015-

10 APUB - 2015-12 WG 5 T. Nakamura 2016-02

IEC 61322 Ed. 2.0

Radiation protection instrumentation - Installed dose equivalent rate

meters, warning assemblies and monitors for neutron radiation of

energy from thermal to 15 MeV

1CD - 2015-

11 A2CD - 2016-03 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 - 2015-

11 A3CD - 2016-03 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

estimation of ambient dose equivalent rate from photon

radiation

3CD - 2015-

10 A4CD - 2016-02 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 - 2015-

10 A4CD - 2016-03 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 - 2015-

11 A2CD - 2016-03 PT 62945 L. Hudson 2017-08

IEC 62957-1 Ed. 1.0

Radiation instrumentation - Semi-empirical method for

performance evaluation of detection and radionuclide

identification - Part 1: Performance evaluation of the

instruments, featuring radionuclide identification in static

mode

1CD - 2015-

02 A2CD - 2015-05 PT 62957-1

L. Ooi/M.

Mayorov 2017-10

IEC 62963 Ed. 1.0 Bottle/can liquid X-ray inspection system ANW - 2014-

11 1CD - 2015-10 WG 17 Kejun Kang 2018-02

PNW/TS 45B-832

Ed. 1.0

Radiation protection instrumentation - Dosemeters for pulsed fields

of ionizing radiation

PNW - 2015-

11 ANW - 2016-04 WG 8 H. Zutz 2018-12

UNCLASSIFIED


IEC Standards

• TC 104 - Environmental conditions, classification and methods of test


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.


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

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


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




and their severities - Section 1: Storage

1CD - 2015-01 A2CD - 2015-05 MT 19


IEC 60721-3-2




and their severities - Section 2:

Transportation

1CD - 2015-02 A2CD - 2015-06 MT 19


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 T. Ishida

UNCLASSIFIED


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


Questions? Comments?


Backup Slides


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


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


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

Documents

The Standards Cycle and Conformity Testing · 2016. 6. 3. · Peter Chiaro Oak Ridge National Laboratory . 2 The Standards Cycle and Conformity Testing UNCLASSIFIED Agenda •Define