Criteria and guidance for direct radiobioassay (in vivo) and indirect radiobioassay (in vitro) are given in separate sections of this standard. In addition, examples to clarify concepts and methods that are described in this standard, and information that may be useful in implementing this standard, are presented in annexes to the standard. The annexes are illustrative and are not a part of the standard.

This standard addresses the following:

1. the accuracy (bias and precision) of direct (in vivo) measurements of activity and quantities of selected important radionuclides in test phantoms and indirect (in vitro) measurements of activity and quantities of selected important radionuclides in test samples;

2. methods for determining the minimum detectable amount;

3. minimum testing levels and testing ranges;

4. requirements for reporting radiobioassay results by service laboratories;

5. quality assurance in service laboratories;

6. quality control in service laboratories;

7. protocol for reporting test evaluations by service laboratories to the testing laboratory;

8. default procedures when the service laboratory customer does not specify the performance criteria.

The scope of this standard does not include the following:

1. detailed radiochemical methods for separating radionuclides from biological samples;

2. detailed procedures for in vivo and in vitro radioactivity measurements;

3. metabolic data and mathematical models for converting radiobioassay results into absorbed dose and equivalent dose;

4. any aspects of a service laboratory customer's radiation protection program;

5. procedures for the preparation and distribution of test samples and phantoms by the testing laboratories.

Analytical methods for radiobioassay are not currently standardized but are available in the literature. Some analytical methods are provided in references appended to this standard and in other American National Standards Institute (ANSI) standards for specific radionuclides. Guidance for converting radiobioassay results into dose are provided in publications of federal and state regulations and guides, the International Commission on Radiological Protection (ICRP), the National Council on Radiation Protection and Measurements (NCRP), and the International Commission on Radiological Units and Measurements (ICRU). Recommendations of the ICRP, NCRP, and ICRU, and experience with the practical application of these recommendations to the conduct of radiobioassay services and the interpretation and use of bioassay results in radiation protection programs, have been considered in the development of this standard.

Purpose

The purpose of this standard is to provide criteria for quality assurance, evaluation of performance, and the accreditation of radiobioassay service laboratories. These criteria include bias, precision, and determination of the MDA or MDC.