scope:

This document establishes the general requirements for the in vitro amplification of nucleic acid sequences (DNA or RNA). It is applicable to the testing for microorganisms and viruses from the food chain using the polymerase chain reaction (PCR).

The minimum requirements laid down in this document are intended to ensure that comparable and reproducible results are obtained in different laboratories.

This document has been established for microorganisms from the food chain and is applicable to:

- products intended for human consumption;

- products for feeding animals;

- environmental samples in the area of food and feed production and handling;

- samples from the primary production stage.

Validation of alternative methods, single laboratory validation, interlaboratory validation for nonproprietary or alternative confirmation methods are not covered by this document. These items in the frame of the microbiology of the food chain are covered by the ISO 16140 series.