American National Standard N13.30
Performance Criteria for Radiobioasay
This
American National Standard provides criteria for radiobioassay service
laboratory quality assurance, performance evaluation, and
accreditation. Criteria are included for determining bias, precision,
and Minimum Detectable Amount (MDA) of a procedure. Technical standards
for a performance testing program are provided. Criteria are also given
for testing ranges and limits of bias and precision, to be used in an
accreditation program. Information for direct radiobioassay (in vivo)
is presented in a separate section of this standard. This standard
provides useful and practical information and guidance for users,
providers, and regulators of radiobioassay services.
This standard includes four appendices. These appendices are not a part
of this standard; however, they provide rationale, practical
implications, and background information for the concepts and criteria
included in the standard. Appendices describe the derivation and use of
the MDA, bias, and precision formulas and statistics, test sample
accuracy, and the testing ranges. Examples of calculations for the MDA,
propagation of error, and presentation of analytical results are also
given. Not included in this standard are detailed radiochemical
procedures for measurement and separation of radionuclides. Information
on metabolic data, mathematical models, and radiation protection
programs is not part of this standard.
Development of this standard was coordinated with other ANSI Working
Groups. Thus, this standard is complementary to other ANSI standards,
the Code of Federal Regulations, and DOE Orders and Regulations.
In
1989, a draft of this standard was issued for trial use and comment for
a 1-y period. Subsequent to this, a reconstituted Working Group
produced the final version of 1995. During the period between 1990 and
1995, portions of the draft standard have been included in many
government and industrial radiobioassay program documents.
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