American National Standard N43.10
Safe Design and Use of
Panoramic, Wet Source Storage Gamma Irradiators (Category IV) and Dry
Source Storage Gamma Irradiators (Category II)
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.
Their number has been increasing with source storage capacity of
individual irradiators reaching the multi-petabequerel,
(multimegacurie) range.
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 and consumer products.
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. This standard is an industry
consensus and does not take precedence over applicable federal or state
regulations. Because of the variety of designs, four general categories
of irradiators have been established to facilitate preparation of
standards. Separate standards establish 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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