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<p>This International Standard provides criteria for quality assurance and control, and evaluation of performance of radiobioassay service laboratories.</p>
<p>Criteria and guidance for <em>in vivo</em> radiobioassay and <em>in vitro</em> radiobioassay are given in separate clauses.</p>
<p>The following are within the scope of this International Standard:</p>
<ul>
<li>the accuracy of
<ul>
<li><em>in vivo</em> measurements of activity and quantities of selected important radionuclides in test phantoms, and</li>
<li><em>in vitro</em> measurements of activity and quantities of selected important radionuclides in test samples;</li>
</ul>
</li>
<li>minimal requirements for detection limit;</li>
<li>minimum testing levels and testing ranges;</li>
<li>requirements for reporting radiobioassay results by service laboratories;</li>
<li>quality assurance in service laboratories;</li>
<li>quality control in service laboratories;</li>
<li>protocol for reporting test evaluations by service laboratories to the testing laboratory;</li>
<li>default procedures when the service laboratory customer does not specify the performance criteria;</li>
<li>applications of <em>y</em><sup>#</sup> for different methods (see Annexes A and B).</li>
</ul>
<p>The following are not within the scope of this International Standard:</p>
<ul>
<li>detailed radiochemical methods for separating radionuclides from biological samples;</li>
<li>detailed procedures for <em>in vivo</em> and <em>in vitro</em> radioactivity measurements;</li>
<li>biokinetic data and mathematical models for converting radiobioassay results into dose (dose assessment);</li>
<li>procedures for the preparation and distribution of test samples and phantoms by the testing laboratories.</li>
</ul>
Reģistrācijas numurs (WIID)
40869
Darbības sfēra
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<p>This International Standard provides criteria for quality assurance and control, and evaluation of performance of radiobioassay service laboratories.</p>
<p>Criteria and guidance for <em>in vivo</em> radiobioassay and <em>in vitro</em> radiobioassay are given in separate clauses.</p>
<p>The following are within the scope of this International Standard:</p>
<ul>
<li>the accuracy of
<ul>
<li><em>in vivo</em> measurements of activity and quantities of selected important radionuclides in test phantoms, and</li>
<li><em>in vitro</em> measurements of activity and quantities of selected important radionuclides in test samples;</li>
</ul>
</li>
<li>minimal requirements for detection limit;</li>
<li>minimum testing levels and testing ranges;</li>
<li>requirements for reporting radiobioassay results by service laboratories;</li>
<li>quality assurance in service laboratories;</li>
<li>quality control in service laboratories;</li>
<li>protocol for reporting test evaluations by service laboratories to the testing laboratory;</li>
<li>default procedures when the service laboratory customer does not specify the performance criteria;</li>
<li>applications of <em>y</em><sup>#</sup> for different methods (see Annexes A and B).</li>
</ul>
<p>The following are not within the scope of this International Standard:</p>
<ul>
<li>detailed radiochemical methods for separating radionuclides from biological samples;</li>
<li>detailed procedures for <em>in vivo</em> and <em>in vitro</em> radioactivity measurements;</li>
<li>biokinetic data and mathematical models for converting radiobioassay results into dose (dose assessment);</li>
<li>procedures for the preparation and distribution of test samples and phantoms by the testing laboratories.</li>
</ul>
