The standard includes the qualification requirements for those who engage in the design, fabrication, assembly, testing, repair, or modification of industrial gamma radiography system equipment or source changers.

The operational use of such equipment is not covered by this standard.¹

Those provisions containing the word “shall” identify requirements that are necessary to meet the standards of protection in this document. Those using the word “should” indicate advisory recommendations that are to be applied when practical.

¹ If exposure devices are to be used as radioactive material transport packages, they shall also comply with current applicable transport regulations

irradiators (Category I) that contain sealed gamma- or

beta-emitting sources for the irradiation of objects or materials.

The standard establishes criteria to be used in the proper design,

fabrication, installation, use, and maintenance of these

irradiators that will ensure a high degree of radiation safety.

This standard applies to irradiator designs produced after the date

of this publication. This standard is not a substitute for

regulations. Nothing in this standard relieves persons from

complying with applicable federal and state requirements governing

the use of these irraditors or devices.

The standard provides a manufacturer of sealed radioactive
sources with a set of tests to evaluate the safety of its products
under specified conditions, and also to assist a user of such
sources to select types that suit an application, especially where
protection against radioactive contamination is concerned. This
standard also provides guidance to regulatory authorities.

The tests fall into several groups, including, for example,
exposure to abnormally high and low temperature and a variety of
mechanical tests. Each test can be applied in several degrees of
severity.

Although the standard classifies sealed sources by a variety of
tests, it does not imply that a sealed source will maintain its
integrity if used continuously at the rated classification. For
example, a sealed source tested for one hour at 600°C (1112°F) may
or may not maintain its integrity if used continuously at 600°C
(1112°F).

Table 4 of this standard includes a list, which is not intended
to be comprehensive, of typical applications of sealed radioactive
sources with a suggested performance classification for each
application. These classifications are minimum requirements
corresponding to the applications in the usual environment. Factors
to be considered for applications in especially severe environments
are listed in Sections 4.2 and 4.3.

This standard makes no attempt to classify the design of
sources, their method of construction, or their calibration in
terms of the radiation emitted.

Several subjects relating to sealed sources and their testing
are not treated in detail in this standard, including selected
brachytherapy sources, self-luminous light sources and IAEA tests
for special-form radioactive material. These subjects are covered
by separate standards as listed in Section 4.4.

called devices, that use sealed radioactive sources or

machinegenerated sources for the determination or control of

thickness, density, level, interface location, particle size

distribution, or qualitative or quantitative chemical composition.

The standard establishes a system for classification of the gauging

devices based on performance specifications relating to radiation

safety. In addition to specific tests for use conditions and

accident conditions (fire), guidelines for other safety features

and considerations are presented. This standard does not apply to

the measurement performance of gauging devices.

safety aspects of the design of non-medical x-ray equipment

operating at energies below 1 MeV for radiographic and radioscopic

applications, wherein the x-rays are generated by electronic means.

It does not apply to x-ray equipment used for industrial gauging

applications. It does not include safety guidelines or

considerations outside the realm of radiation safety.

safety aspects of the design and operation of x-ray diffraction and

fluorescence analysis equipment. It does not include electrical

safety guidelines or other safety considerations outside the realm

of radiation safety.

This standard does not specify the luminance of the
self-luminous light source; however, many of these sources are used
for safety proposes. Therefore, the luminosity must be commensurate
with the intended use of the source(s).

Note: Radioactive self-luminous light sources used in or on
timepieces are not covered by this standard. The following
documents apply to radioluminous timepieces:

a. International Atomic Energy Agency, Radiation Protection
Standards for Radioluminous Timepieces, Safety Series No. 23,
Vienna, 1967.

b. International Association for Standardization,
Radioluminescence for Time Measurement Instruments – specifications
(ISO 3157), Geneva, 1975.

c. Nuclear Energy Agency, Radiation Protection Standards for
Gaseous Tritium Light Devices, Organization for Economic
Co–operation and Development, Paris, 1973.

The objectives of this standard are to establish minimum
prototype testing requirements for radioactive self-luminous light
sources, to promote uniformity of marking such sources, and to
establish minimum physical performance for such sources.

This standard is primarily directed toward ensuring adequate
containment of the radioactive material. Other factors, such as
quality control, external radiation levels, radiotoxicity of the
radionuclide, its chemical and physical form, and quantity of
radioactive material in the source, also shall require
consideration in view of the everpresent objective of keeping
exposures as low as is reasonably achievable (ALARA). Compliance
with this standard does not necessarily satisfy all requirements
for manufacture and use that may be imposed by governmental
regulatory agencies.

It should be noted that this standard covers a range of radiation sources similar to that of ANSI/HPS N43.11, “Safe Operating Practice for Non-Medical X-ray Radiographic and Radioscopic Equipment.” ANSI/HPS N43.3-2008 is appropriate for use by technical experts for the design of installations and for the establishment of radiation protection programs. It is useful only to a limited extent for day-to-day operation of facilities. It is recommended that ANSI/HPS N43.11 be consulted for routine operational use.

Those recommendations containing the word “shall” identify requirements that are necessary to meet the standards of protection in this document. Those using the word “should” indicate advisory recommendations that are to be applied when practical.

• Direct screening of humans to detect objects hidden within an individual’s body or clothing.

• Knowingly exposing human occupants to the primary beam when screening vehicles or structures.

• Screening of orthopedic casts and prosthetic devices while being worn.

The standard provides requirements specific to the ionizing radiation safety aspects of both the design and operation of these systems. It does not include electrical safety guidelines or any other safety, performance, or use considerations outside the realm of radiation safety. The limits in this standard are not intended to apply to stowaways not authorized to be in the area and not known to be present prior to scanning.

It is recognized that the need for security might sometimes call for exceeding the dose limits set in this standard. This should be based on an analysis demonstrating that the security benefit outweighs the risk from the radiation exposure incurred by the individuals screened.

This standard does not address the evaluation of the societal benefit of security screening. Therefore, screening operations that exceed this standard’s dose limits are beyond the scope of this standard and shall not claim compliance with this standard. Medical diagnostic systems should be used under medical supervision and are not covered by this standard.

irradiators (Category III) that contain sealed gamma emitting

sources for the irradiation of objects or materials. The standard

establishes the criteria to be used in the proper design,

fabrication, installation, use, and maintenance of these

irradiators which will ensure a high degree of radiation safety at

all times.