ISO 12790-1:2001 Historical

This part of ISO 12790 provides criteria for quality assurance and control, evaluation of performance and the accreditation of radiobioassay service laboratories.

Criteria and guidance for direct radiobioassay (in vivo) and indirect radiobioassay (in vitro) are given in separate clauses of this part of ISO 12790.

This part of ISO 12790 addresses:

• the accuracy 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;
• methods for determining the minimum detectable amount;
• minimum testing levels and testing ranges;
• requirements for reporting radiobioassay results by service laboratories;
• quality assurance in service laboratories;
• quality control in service laboratories;
• protocol for reporting test evaluations by service laboratories to the testing laboratory;
• default procedures when the service laboratory customer does not specify the performance criteria.

The scope of this part of ISO 12790 does not include:

• detailed radiochemical methods for separating radionuclides from biological samples;
• detailed procedures for in vivo and in vitro radioactivity measurements;
• metabolic data and mathematical models for converting radiobioassay results into absorbed dose and dose equivalent;
• 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. Guidance for converting radiobioassay results into dose are provided in publications of national and international regulations and guides, the International Commission on Radiological Protection (ICRP), the National Council on Radiation Protection and Measurement (NCRP), the International Atomic Energy Agency (IAEA) and the International Commission on Radiological Units and Measurements (ICRU). Recommendations of the ICRP, NCRP, IAEA 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 programmes, have been considered in the development of this part of ISO 12790.