American National Standard N43.15
Safe Design and Use of Self-Contained Wet Source Storage Gamma Irradiators (Category III)
The
1950's and 1960's can be characterized as the research era for
radionuclide applications. Based on this research, a number of
commercial gamma irradiators started operation in the early 1960's.
Gamma irradiators are used for a variety of purposes in research,
industry, and other fields. Typical uses are:
1. Sterilization or microbial reduction in medical and pharmaceutical supplies.
2. Microbial reduction and disinfestation of food products.
3. Radiation effects studies.
4. Chemical and polymer synthesis and modifications.
5. Insect eradication through sterile male release programs.
The
number and types of irradiators supporting these and other applications
are continually growing. Source requirements for any particular
irradiator may vary from a few curies to several million curies.
Irradiator designs can be many and varied to suit individual needs;
therefore, it is essential to establish basic criteria to ensure a high
standard of radiation safety in the design and use of irradiators, but
in a way which does not unnecessarily restrict the logical use and
growth of radionuclide applications.
This standard sets forth
basic safety standards which are recommended in irradiator design and
use. Its use by Regulatory Authorities, relative to the review of
radionuclide applications, is encouraged. In the event of a conflict
between this standard and federal or state regulation, the regulation
shall take precedence.
Because of the variety of designs, four
general categories of irradiators have been established to facilitate
preparation of standards. A separate standard establishes the criteria
to be used in the design, fabrication, installation, use, and
maintenance for each irradiator category.
The categories are as follows:
Category
I - Self-contained, dry source storage irradiators. American National
Standard N43.7. An irradiator in which the sealed source is completely
contained in a dry container constructed of solid materials, the sealed
source is shielded at all times, and human access to the sealed source
and the volume undergoing irradiation is not physically possible in its
designed configuration.
Category II - Panoramic, dry source
storage irradiator. American National Standard N43.10. A controlled
human access irradiator in which the sealed source is contained in a
dry container constructed of solid materials, and the sealed source is
fully shielded when not in use; the sealed source is exposed within a
radiation volume that is maintained inaccessible during use by an entry
control system.
Category III - Self-contained, wet source storage
irradiator. American National Standard N43.15. An irradiator in which
the sealed source is contained in a storage pool (usually containing
water), the sealed source is shielded at all times, and human access to
the sealed source and the volume undergoing irradiation is physically
restricted in its designed configuration and proper mode of use.
Category
IV - Panoramic, wet source storage irradiator. American National
Standard N43.10. A controlled human access irradiator in which the
sealed source is contained in a storage pool (usually containing
water), and the sealed source is fully shielded when not in use; the
sealed source is exposed within a radiation volume that is maintained
inaccessible during use by an entry control system.
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