HPS N13.30-2011 (R2017) PDF Download

The HPS N13.30-2011 (R2017) standard provides criteria and guidance for both direct and indirect radiobioassay measurements. The standard includes separate sections for in vivo (direct) and in vitro (indirect) measurements, with illustrative examples provided in annexes. The standard covers various aspects including accuracy, minimum detectable amount, testing levels and ranges, reporting requirements, quality assurance and control, reporting protocols, and default procedures.

However, there are certain aspects that are not included in the scope of this standard. This includes detailed radiochemical methods for separating radionuclides from biological samples, specific procedures for radioactivity measurements, conversion of radiobioassay results into absorbed dose, customer’s radiation protection program, and procedures for preparing and distributing test samples and phantoms.

The standard acknowledges that analytical methods for radiobioassay are not currently standardized but are available in the literature and references appended to the standard. Conversion of radiobioassay results into dose is guided by publications from federal and state regulations, as well as organizations like the ICRP, NCRP, and ICRU. The development of the standard has considered recommendations from these organizations and practical application in radiobioassay services and radiation protection programs.

The purpose of this standard is to establish criteria for quality assurance, performance evaluation, and accreditation of radiobioassay service laboratories. These criteria encompass bias, precision, and determination of the minimum detectable amount or minimum detectable concentration.