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DOE G 441.1-7
(formerly 10 CFR 835/E1)
06-17-99

PORTABLE MONITORING
INSTRUMENT CALIBRATION GUIDE

for use with
Title 10, Code of Federal Regulations, Part 835,
Occupational Radiation Protection

Assistant Secretary for Environment,
Safety and Health (THIS PAGE INTENTIONALLY LEFT BLANK)
CONTENTS

CONTENTS Page

1. PURPOSE AND APPLICABILITY. . . . . . . . . . . . . . . . . .1

2. DEFINITIONS. . . . . . . . . . . . . . . . . . . . . . . . .2

3. DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . .3

4. IMPLEMENTATION GUIDANCE. . . . . . . . . . . . . . . . . . .4

4.1 INSTRUMENT SELECTION. . . . . . . . . . . . . . . . . . . .4
4.1.1 Type Testing . . . . . . . . . . . . . . . . . . . .4
4.1.2 Acceptance Testing . . . . . . . . . . . . . . . . .5

4.2 INSTRUMENT CALIBRATION. . . . . . . . . . . . . . . . . . .5

4.3 OPERABILITY TESTS . . . . . . . . . . . . . . . . . . . . .5

4.4 MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . .5

4.5 CALIBRATION EQUIPMENT/CALIBRATION QUALITY . . . . . . . . .6

4.6 LABORATORY DOCUMENTATION. . . . . . . . . . . . . . . . . .6
4.6.1 Laboratory Protocol. . . . . . . . . . . . . . . . .6
4.6.2 Laboratory Records . . . . . . . . . . . . . . . . .6
4.6.3 Instrument Calibration Records . . . . . . . . . . .6
4.6.4 Instrument Location. . . . . . . . . . . . . . . . .6

4.7 LABORATORY AND STAFF. . . . . . . . . . . . . . . . . . . .7
4.7.1 Laboratory . . . . . . . . . . . . . . . . . . . . .7
4.7.2 Calibration Staff Qualifications . . . . . . . . . .7
4.7.3 Calibration Staff Training . . . . . . . . . . . . .7

4.8 ASSESSMENTS . . . . . . . . . . . . . . . . . . . . . . . .8

5. REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . .9

6. SUPPORTING DOCUMENTS . . . . . . . . . . . . . . . . . . . 11

7. ATTACHMENT 1
Request for Changes to Portable Monitoring Instrument Calibration GuidePage 1
ACRONYMS

AEC Atomic Energy Commission
ALARA as low as is reasonably achievable
ANSI American National Standards Institute
DOE U.S. Department of Energy
DOE G DOE Guide
DOE O DOE Order
DOE-STD DOE Standard
NCSL National Conference of Standards Laboratories
NIST National Institute of Standards and Technologies
RCS RADIOLOGICAL CONTROL, DOE-STD-1098-99
RPP radiation protection program
PORTABLE MONITORING
INSTRUMENT CALIBRATION

1. PURPOSE AND APPLICABILITY

This Guide provides an acceptable methodology for establishing and operating a program for selecting, calibrating,
testing, and maintaining portable radiation monitoring instruments that will comply with U.S. Department of Energy
(DOE) requirements specified in Title 10 of the Code of Federal Regulations (CFR), Part 835, Occupational Radiation
Protection (DOE 1998a); hereinafter referred to as 10 CFR 835. In particular, this Guide provides guidance for
achieving compliance with the instrument calibration requirements of paragraph 401(b) of 10 CFR 835. For
completeness, this Guide also identifies applicable guidance provided in DOE-STD-1098-99, RADIOLOGICAL
CONTROL (DOE 1999a), hereinafter referred to as the RCS, and recommendations contained in secondary
documents (American National Standards Institute (ANSI) Standards, etc.) concerning instrument calibration.

This Guide amplifies the regulatory requirements of 10 CFR 835, which are enforceable under the provisions of
Sections 223(c) and 234A of the Atomic Energy Act of 1954, as amended (AEC 1954).

Except for requirements established by regulation, contract, or administrative means, the provisions in this Guide are
DOE's views on acceptable methods of program implementation and are not mandatory. Conformance with this
Guide will, however, create an inference of compliance with the related regulatory requirements. Alternate methods
that are demonstrated to provide an equivalent or better level of protection are acceptable. DOE encourages its
contractors to go beyond the minimum requirements and to pursue excellence in their programs.

The word "shall" is used in this Guide to designate requirements from 10 CFR 835. Compliance with 10 CFR 835 is
mandatory except to the extent an exemption has been granted pursuant to 10 CFR 820, Procedural Rules for DOE
Nuclear Activities (DOE 1997a). The words "should" and "may" are used to denote optional program
recommendations and permissible alternatives, respectively.

This Guide is applicable to all DOE activities that are subject to the requirements of 10 CFR 835.

2. DEFINITIONS

Terms defined in 10 CFR 835 are used in this Guide consistent with their regulatory definitions.

Acceptance testing: Evaluation or measurement of performance characteristics to verify that certain stated
specifications and contractual requirements are met.

Check source: A radioactive source, not necessarily calibrated, that is used to confirm the continuing satisfactory
operation of an instrument.

Detector: A device or component designed to produce a quantifiable response to ionizing radiation, normally
measured electronically.

Functional tests: Tests (often qualitative) to determine that an instrument is operational and capable of performing
its intended function. Such tests may include, for example, battery check, zero setting, or source response checks.

Geotropism: A change in an instrument's reading as its orientation changes, due to gravitational effects.

Instrument (radiation detection): A complete system consisting of one or more subassemblies (e.g., detector,
readout, etc.) designed to quantify one or more characteristics of ionizing radiation or radioactive material.

Performance tests: Tests performed periodically over the life of an instrument to verify that it continues to meet
operational requirements. Examples of performance tests are response time and geotropism.

Portable monitoring instrument: An instrument intended to be operated while being carried by an individual.

Source response check: A functional test that includes the observation of the response of an instrument to a check
source.

Test: A procedure whereby an instrument, component, or circuit is evaluated against certain criteria for satisfactory
operation.

Traceability: The ability to show, through documentation, that a particular instrument or radiation source has been
calibrated using either the national standard or a transfer standard in a chain or echelon of calibrations, ultimately
leading to a comparison with the national standard.

Type test: An initial test of one or more production instruments made to a specific design to show that the design
meets certain specifications. 3. DISCUSSION

A comprehensive radiation protection program (RPP) requires reliable means of monitoring radiological conditions.
Such monitoring requires the use of properly functioning radiation monitoring instruments.

10 CFR 835.401(b) requires that instruments and equipment used for monitoring radiological conditions shall be
appropriate for the radiation(s) encountered and the environmental conditions and be routinely maintained,
calibrated, and tested. American National Standards Institute (ANSI) Standard N323A, Radiation Protection
Instrumentation Test and Calibration, Portable Survey Instruments (ANSI 1997) provides comprehensive guidance
for implementing a portable monitoring instrument calibration program. The recommendations contained therein are
mandatory for DOE sites that are subject to DOE Order 5480.4, ENVIRONMENTAL PROTECTION, SAFETY, AND
HEALTH PROTECTION STANDARDS (DOE 1993).

This Guide provides guidance for a portable monitoring instrument calibration program that addresses selection
(acceptance testing), calibration, tests for operability (functional tests and performance tests), maintenance,
calibration equipment, calibration quality, laboratory documentation, facilities, and staff. Note that, while 10 CFR
835.401(b) applies to all radiation monitoring instruments and equipment, the guidance provided in this Guide applies
specifically to portable monitoring instruments only. This Guide does not provide specific guidance for:

installed or stationary monitors such as air monitors, portal monitors, and other non-portable monitoring
instrumentation;

laboratory equipment such as liquid scintillation counters and complex laboratory multi-channel analyzers;

low exposure rate instruments (even if they are portable) with ranges extending below 0.1mrad/h;

personal monitoring devices, such as thermoluminescent dosimeters and radio-sensitive film. These devices are
addressed by DOE-STD-1111-98, DEPARTMENT OF ENERGY LABORATORY ACCREDITATION PROGRAM
ADMINISTRATION (DOE 1998b);

pocket ionization chambers. These devices are addressed by ANSI N13.5, Performance Specifications for
Direct Reading and Indirect Reading Pocket Dosimeters (ANSI 1989a); and

electronic dosimeters. Appropriate guidance regarding selection, calibration, testing and maintenance of
electronic dosimeters is provided in ANSI N13.27, Performance Specifications for Pocket-sized Alarming
Dosimeter/Ratemeters (ANSI 1981).

While this Guide does not apply directly to the above listed devices, many of the concepts and practices discussed
in this Guide, and in the referenced consensus standards, may be applicable to these devices. These concepts and
practices should be considered when establishing calibration and maintenance programs for these devices. 4. IMPLEMENTATION GUIDANCE

This section provides guidance for selecting, calibrating, testing, and maintaining portable radiation monitoring
instruments and equipment. The portable monitoring instrument maintenance and calibration program should be
developed and conducted consistent with ANSI N323A.

The essential elements of an acceptable portable instrument calibration program are shown below with reference to
10 CFR 835, with additional elements provided in ANSI N323A:

a system that ensures calibration shall be performed periodically on each instrument (10 CFR 835.401(b)(1)).
ANSI N323A (4.9) recommends that calibration be performed at least annually;

an internal audit program shall be conducted no less frequently than every 36 months (10 CFR 835.102); and

a records program shall be established that documents results of maintenance and calibration performed on
instruments and equipment used for area monitoring and contamination control (10 CFR 835.703(d)), includes
the maintenance of training records (10 CFR 835.704(a)), documents changes in equipment, techniques, and
procedures used for monitoring, (10 CFR 835.704(e)), and documents the results of internal audits (10 CFR
835.704(c)).

Further, the following elements should be in place for those activities that perform their own instrument calibrations:

procedures addressing the calibration of reference sources, support instruments, and field instruments;

a method to determine when instruments have been returned out-of-calibration and a method to notify users of
out-of-calibration instruments;

adequate technical staff with appropriate training in instrument calibration; and

a dedicated facility that permits calibrations without outside physical interference.

For those activities that rely on contracted organizations to perform calibration services, the RPP should include or
make reference to a Memoranda of Agreement with the calibration contractor(s) that assures compliance with
applicable DOE requirements.

4.1 INSTRUMENT SELECTION

Instruments shall be selected that are appropriate to measure the type(s), levels, and energies of radiation(s)
encountered and for the existing environmental conditions (10 CFR 835.401(b)(2) & (b)(3)). To ensure these
requirements are met, the initial instrument selection process should include knowledge of facility radiation types,
energies, anticipated or known ranges, and results of available instrument performance and testing data (vendor or
independent) The selection process should include type testing and acceptance testing.

4.1.1 Type Testing

DOE encourages implementation of a formal instrument qualification (type testing) process in accordance with the
relevant portions of ANSI N323A, ANSI N42.17A, Performance Specifications for Health Physics Instrumentation -
Portable Instruments for Use In Normal Environmental Conditions (ANSI 1989b), and ANSI N42.17C, Performance
Specifications for Health Physics Instrumentation - Portable Instruments for Use In Extreme Environmental
Conditions (ANSI 1989c).

4.1.2 Acceptance Testing

Prior to use, new instruments should be subjected to acceptance testing as detailed in ANSI N323A. Instruments
that do not meet the selected specifications should not be accepted or used by the facility.

4.2 INSTRUMENT CALIBRATION

ANSI N323A sets forth criteria for proper portable monitoring instrument calibration. An instrument calibration hall
be performed on each instrument periodically at an established frequency (10 CFR835.401(b)(1)). ANSI N323A
establishes an annual calibration frequency for portable monitoring instruments. The calibration frequency should
be determined and the calibration should be performed according the details presented in the above referenced
consensus standards. If routine checks (e.g., routine operability tests and as-found tests) indicate that the response
of an instrument (or type of instrument) remains stable over a long period of time, then the calibration frequency may
be extended. Conversely, if routine checks indicate that an instrument (or type of instrument) fails to provide a
stable response over the prescribed calibration interval, then the calibration interval should be shortened. The
reliability of an instrument (or type of instrument) and appropriate calibration frequency should be determined by
collecting and analyzing data in accordance with National Conference of Standards Laboratories Recommended
Practice RP-1, Establishment and Adjustment of Calibration Intervals (NCSL 1989).

4.3 OPERABILITY TESTS

Functional tests should be performed prior to initial use of an instrument in the field. Functional tests should be
detailed in the instrument-use procedures and should include, as a minimum: general condition; battery condition;
verification of current calibration (i.e., check to see that the date due for calibration has not passed); background
readings; and other tests (high voltage, zero setting, alarm functions, etc.) as applicable to the instrument.
Functional tests should also include a source response check (i.e., observing the instrument response to a check
source) before initial operation. During use in the field, instruments should be tested with a check source to ensure
that the readings remain within prescribed limits. This should be done as prescribed in ANSI N323A. The perform-

ance of functional tests during use in the field should be appropriately documented. This may be as simple as a
check-list on the survey sheet.

Performance tests should be performed periodically and after maintenance to ensure that the instruments continue to
meet performance requirements for field measurements. Examples of performance tests are tests for geotropism and
response time. Performance requirements should be met as specified in the applicable sections of ANSI N323A,
ANSI N42.17A, and ANSI N42.17 C. These tests may be conducted as part of the calibration procedure.

4.4 MAINTENANCE

Maintenance shall be performed periodically on an established frequency (10 CFR 835.401(b)(1)). Maintenance
activities should be directed toward ensuring that the instruments continue to meet the required accuracy for field
measurements.

All preventive and corrective maintenance should be performed using components and procedural recommendations
at least as stringent as those specified by the instrument manufacturer. If the manufacturer does not provide routine
maintenance procedures, a procedure should be written and approved by staff and management in the organization
performing the maintenance. 4.5 CALIBRATION EQUIPMENT/CALIBRATION QUALITY

The calibration laboratory should possess and maintain appropriate radiation and non-radiation standards to
achieve reliable operation.

Instruments should be calibrated with appropriate standards that are traceable to the National Institute of Standards
and Technology (NIST) or its international equivalents. Calibrations of reference radiation fields or sources,
calibration assemblies, maintenance of standards, and check sources should be in accordance with ANSI N323A.
For information on acceptable reference sources for calibration for various radiation types, refer to Table 2 of ANSI
N323A. Calibration quality including calibration field accuracies and quantities should be in accordance with ANSI
N323A.

For non-radiation quantities (e.g., temperature, humidity, pressure, voltage, current, etc.), the facility may use
standards based on traceability to NIST.

4.6 LABORATORY DOCUMENTATION

The calibration laboratory should maintain the following sets of documentation: (1) the laboratory protocol; (2) the
laboratory records; and (3) the calibration records. Historical records should be maintained to detail any changes or
revisions in procedures or protocols. The laboratory protocol describes the laboratory operations, i.e., what the
laboratory is expected to do and how it is expected to do it. This documentation should also include the detailed
calibration procedures for each instrument routinely calibrated. The laboratory records, on the other hand, are those
records that document the activities of the laboratory. Finally, the calibration records are those records that
document the maintenance, calibration, and testing of each instrument and source used.

4.6.1 Laboratory Protocol

Each DOE laboratory should have a written protocol for operations. Components that should be included in the
protocol are listed in ANSI/NCSL Z540-1-1994, American National Standard for Calibration - Calibration
Laboratories and Measuring and Test Equipment - General Requirements (ANSI/NCSL 1994).

4.6.2 Laboratory Records

Guidance for record-keeping can be found in ANSI N323A and ANSI N13.6, American National Standard Radiation
Protection Practice for Occupational Radiation Exposure Records Systems (ANSI 1989d). DOE G 441.1-11,
OCCUPATIONAL RADIATION PROTECTION RECORD-KEEPING AND REPORTING GUIDE (DOE 1999b),
provides additional guidance for maintaining records consistent with the requirements of 10 CFR 835.

4.6.3 Instrument Calibration Records

A record shall be maintained for results of calibration and maintenance performed for each instrument (10 CFR
835.703(d)). Refer to DOE G 441.1-11 and ANSI N323A for specific items that should be included.

4.6.4 Instrument Location

A system for tracking the location of portable survey instruments and for recalling those instruments for
recalibration should be established. The location of portable survey instruments should be known by the calibration
staff or by some identifiable group assigned with that responsibility. Because instruments may incorporate or be
accompanied by an accountable sealed radioactive source, instrument tracking may be required as part of the sealed
radioactive source control program. See DOE G 441.1-13, SEALED RADIOACTIVE SOURCE ACCOUNTABILITY
AND CONTROL GUIDE (DOE 1999c) to determine if this is the case.

4.7 LABORATORY AND STAFF

The location, design, and use of the calibration laboratory should ensure that conditions within the laboratory will
not affect calibration quality. In addition, the laboratory shall be designed to keep worker exposures ALARA in
compliance with 10 CFR 835.1001 - 1003. The laboratory should also have an appropriate selection of calibration
equipment and should be operated with a properly organized and trained staff. Additional guidance may be found in
DOE G 441.1-2, OCCUPATIONAL ALARA PROGRAM GUIDE (DOE 1999d), and Chapter 3 of the RCS.

4.7.1 Laboratory

The effect of external conditions on the internal environment of the calibration laboratory should be considered in
selecting the facility site. The laboratory should be sited away from, or otherwise isolated from, sources of
mechanical vibration and shock, sources of electrical and electromagnetic interference, and other potential sources
of interference with the proper calibration of instrumentation. If such potential sources exist, the laboratory should
have documentation that demonstrates an absence of adverse effects on calibration accuracy.

The electrical power should be appropriate for the equipment used, suitably stable, and free of switching surges and
significant line noise. When necessary, local auxiliary voltage stabilizers, filters, and uninterruptable power supplies
should be provided.

The laboratory environment should be controlled to ensure that environmental conditions do not affect the
calibration quality. The conditions described in ANSI N323A, Table 1, should be considered and implemented, to
the extent practicable and appropriate.

Calibration areas should not be used for storage of instruments, equipment, or sources. Such storage may lead to
variable scatter or abnormal ambient radiation conditions.

4.7.2 Calibration Staff Qualifications

The calibration laboratory manager and the individual in charge of the day-to-day operation of the calibration
laboratory should have the authority to conduct operations free from any influence that could adversely affect the
quality or impartiality of the services offered. Refer to DOE STD-1107-97, KNOWLEDGE, SKILLS, AND ABILITIES
FOR KEY RADIATION PROTECTION POSITIONS AT DOE FACILITIES (DOE 1997b) and DOE G 441.1-1,
MANAGEMENT AND ADMINISTRATION OF RADIATION PROTECTION PROGRAMS GUIDE (DOE 1999e) for
guidance on the recommended education, training, and skills for these two positions. The laboratory manager
should understand the laboratory protocol, ensure it is followed, and should, at least annually, evaluate staff
competence and the need for training. In smaller operations, the manager may also be in charge of day-to-day
operations.

4.7.3 Calibration Staff Training

All staff employed in calibration work shall be trained in radiation safety prior to receiving occupational exposure (10
CFR 835.901(a)). DOE G 441.1-12, RADIATION SAFETY TRAINING GUIDE (DOE 1999f) provides additional
guidance.

Apart from radiation safety training, the staff should receive training on the theory of radiation detectors, interaction
of radiation with matter, basic statistics, maintenance of records, quality assurance, and other topics related to the
safe and efficient operation of calibration equipment.

4.8 ASSESSMENTS

Internal audits of the radiation protection program shall be conducted such that, over a three year period, all
functional elements are assessed, including program content and implementation (10 CFR 835.102). DOE G 441.1-1,
MANAGEMENT AND ADMINISTRATION OF RADIATION PROTECTION PROGRAMS GUIDE provides
guidance on the required internal audits. 5. REFERENCES

AEC (Atomic Energy Commission) 1954. Atomic Energy Act of 1954, as amended. Public Law 83-703 (68 Stat. 919),
Title 42 U.S.C. sec. 2011.

ANSI (American National Standards Institute) 1981. Performance Specifications for Pocket-sized Alarming
Dosimeter/Ratemeters. ANSI N13.27. New York, New York.

ANSI 1989a. American National Standard Performance Specifications for Direct Reading and Indirect Reading
Pocket Dosimeters. ANSI N13.5-R1989. New York, New York.

ANSI 1989b. Performance Specifications for Health Physics Instrumentation - Portable Instrumentation for Use in
Normal Environmental Conditions. ANSI N42.17A-1989. New York, New York.

ANSI 1989c. Performance Specifications for Health Physics Instrumentation - Portable Instrumentation for Use in
Extreme Environmental Conditions. ANSI N42.17C-1989. New York, New York.

ANSI 1989d. American National Standard Radiation Practice for Occupational Radiation Exposure Records
Systems. ANSI N13.6-R1989. New York, New York.

ANSI 1997. American National Standard Radiation Protection Instrumentation Test and Calibration, Portable
Survey Instruments. ANSI N323A-1997. New York, New York.

ANSI/NCSL (American National Standards Institute/National Conference of Standards Laboratories) 1994.
American National Standard for Calibration - Calibration Laboratories and Measuring and Test Equipment -
General Requirements. ANSI/NCSL Z540-1-1994. Boulder, Colorado.

DOE (U.S. Department of Energy) 1993. DOE Order 5480.4, ENVIRONMENTAL PROTECTION, SAFETY, AND
HEALTH PROTECTION STANDARDS, dated 1-93. Washington, D.C.

DOE 1997a. 10 CFR 820, U. S. Deparment of Energy, Procedural Rules for DOE Nuclear Activities, 58 FR 43680,
Federal Register, Vol. 58, No. 157, dated 10-8-97. Washington, D.C.

DOE 1997b. DOE-STD-1107-97, KNOWLEDGE, SKILLS, AND ABILITIES FOR KEY RADIATION PROTECTION
POSITIONS AT DOE FACILITIES, dated 1-97. Washington, D.C.

DOE 1998a. 10 CFR 835, U. S. Department of Energy, Occupational Radiation Protection, 63 FR 59662, Federal
Register, Vol. 63, No. 213, dated 11-4-98. Washington, D.C.

DOE 1998b. DOE-STD-1111-98, DEPARTMENT OF ENERGY LABORATORY ACCREDITATION PROGRAM
ADMINISTRATION. Washington, D.C.

DOE 1999a. DOE-STD-1098-99, RADIOLOGICAL CONTROL, under development at time of publication.
Washington, D.C.

DOE 1999b. DOE G 441.1-11, OCCUPATIONAL RECORD-KEEPING AND REPORTING GUIDE, under development
at time of publication. Washington, D.C.

DOE 1999c. DOE G 441.1-13, SEALED RADIOACTIVE SOURCE ACCOUNTABILITY AND CONTROL GUIDE,
dated 4-15-99. Washington, D.C.

DOE 1999d. DOE G 441.1-2, OCCUPATIONAL ALARA PROGRAM GUIDE, dated 3-17-99. Washington, D.C.

DOE 1999e. DOE G 441.1-1, MANAGEMENT AND ADMINISTRATION OF RADIATION PROTECTION
PROGRAMS GUIDE, dated 3-17-99. Washington, D.C.

DOE 1999f. DOE G 441.1-12, RADIATION SAFETY TRAINING GUIDE, dated 3-17-99. Washington, D.C.

NCSL (National Conference of Standards Laboratories) 1989. Recommended Practice RP-1, Establishment and
Adjustment of Calibration Intervals. Boulder, Colorado.

6. SUPPORTING DOCUMENTS

Heaton, II, H. T., and G. T. Lalos. 1983. Calibration Handbook: Ionizing Radiation Measuring Instruments. Naval
Surface Weapons Center. White Oak, Maryland.

International Atomic Energy Agency. 1971. Handbook on Calibration of Radiation Protection Monitoring
Instruments. IAEA Technical Report 133. Vienna, Austria.

U.S. National Bureau of Standards. 1981. Requirements for an Effective National Ionizing Radiation Measurements
Program. NBS Special Publication 603. U.S. Department of Commerce. Washington, D.C.
DOE 441.1-7 Attachment 1
06-17-99 Page 1 (and 2)

UNITED STATES
DEPARTMENT OF ENERGY

Office of Worker Protection Programs and Hazards Management (EH-52/270CC)
19901 Germantown Road, Germantown, MD 20874-1290

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PORTABLE MONITORING INSTRUMENT
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