biological reference interval

specified interval of the distribution of values taken from a biological reference population

Note 1

A reference interval is commonly defined as the central 95 % interval. Another size or an asymmetrical location of the reference interval could be more appropriate in particular cases.

Note 2

A reference interval can depend upon the type of primary samples and the examination procedure used.

Note 3

In some cases, only one biological reference limit is important, usually an upper limit, “x”, so that the corresponding biological reference interval would be less than or equal to “x”.

Note 4

Terms such as “normal range”, “normal values”, and “clinical range” are ambiguous and therefore discouraged.

Note 5

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

3.7

biological reference interval

Gerelateerde termen