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Division C.3.3.2 ‘Fitness-for-purpose’ approach

United Kingdom

Original text. Later amendments are not shown.

For in-house validated methods, as an alternative a ‘fitness-for-purpose’ approachf1 may be used to assess their suitability for official control. Methods suitable for official control shall produce results with a combined standard measurement uncertainty (u) less than the maximum standard measurement uncertainty calculated using the formula below:

Uf=LOD∕22+αC2

where:

  • Uf is the maximum standard measurement uncertainty (μg/kg);

  • LOD is the limit of detection of the method (μg/kg). The LOD must meet the performance criteria set out in point C.3.3.1 for the concentration of interest;

  • C is the concentration of interest (μg/kg);

  • α is a numeric factor to be used depending on the value of C. The values to be used are given in Table 6.

Table 6

Numeric values to be used for α as constant in formula set out in this point, depending on the concentration of interest

C (μg/kg)α
≤ 500,2
51-5000,18
501-1 0000,15
1 001-10 0000,12
> 10 0000,1

Annotations

Footnotes

f1

M. Thompson and R. Wood, Accred. Qual. Assur., 2006, 10, 471-478.