HPS ANSI/HPS N13.30

Criteria and guidance for direct radiobioassay (in vivo) andindirect radiobioassay (in vitro) are given in separate sections ofthis standard. In addition, examples to clarify concepts andmethods that are described in this standard, and information thatmay be useful in implementing this standard, are presented inannexes to the standard. The annexes are illustrative and are not apart 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 importantradionuclides in test phantoms and indirect (in vitro) measurementsof activity and quantities of selected important radionuclides intest samples;

2. methods for determining the minimum detectable amount;

3. minimum testing levels and testing ranges;

4. requirements for reporting radiobioassay results by servicelaboratories;

5. quality assurance in service laboratories;

6. quality control in service laboratories;

7. protocol for reporting test evaluations by ANSI/HPSN13.30-2011 2 service laboratories to the testing laboratory;

8. default procedures when the service laboratory customer doesnot specify the performance criteria.

The scope of this standard does not include the following:

1. detailed radiochemical methods for separating radionuclidesfrom biological samples;

2. detailed procedures for in vivo and in vitro radioactivitymeasurements;

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

4. any aspects of a service laboratory customer’s radiationprotection program;

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

Analytical methods for radiobioassay are not currentlystandardized but are available in the literature. Some analyticalmethods are provided in references appended to this standard and inother American National Standards Institute (ANSI) standards forspecific radionuclides. Guidance for converting radiobioassayresults into dose are provided in publications of federal and stateregulations and guides, the International Commission onRadiological Protection (ICRP), the National Council on RadiationProtection and Measurements (NCRP), and the InternationalCommission on Radiological Units and Measurements (ICRU).Recommendations of the ICRP, NCRP, and ICRU, and experience withthe practical application of these recommendations to the conductof radiobioassay services and the interpretation and use ofbioassay results in radiation protection programs, have beenconsidered in the development of this standard

Edition:

11

Published:

12/16/2011

ANSI:

ANSI Approved

Number of Pages:

40