reference population

group of individuals in a well-defined state of health or disease

Note 1

When biological reference intervals are provided by a manufacturer in the instructions for use, laboratories using the IVD medical device are responsible for verifying that the biological reference populations represent the populations serviced by the laboratories.

Note 2

A biological reference population can be a defined homogenous group of apparently healthy individuals or individuals with a specific medical condition. The concept allows for relating the reference interval to age, gender and ethnicity of the reference population, as appropriate.

Note 3

Adapted from References [42], [43], [44] and [45].

Norm

NEN-EN-ISO 18113-1:2011 en

Titel

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements

Paragraaf

3.8

reference population

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