Standards Development

Scope

This International Standard gives the general requirements for the in vitro amplification of nucleic acid sequences (DNA or RNA). It is applicable to the testing of foodstuffs and isolates obtained from foodstuffs for food-borne microorganisms and viruses using the polymerase chain reaction (PCR).

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

This International Standard has been established for food-borne microorganisms in or isolated from food and feed matrices and is applicable to:

— products intended for human consumption,

— products intended for animal feeding,

— environmental samples in the area of food and feed production, handling, and

— 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 are covered in the frame of the microbiology of the food chain by the series of ISO 16140 Part 2 to Part 6.

Purpose

For the purposes of this document, the following terms and definitions apply. For definitions concerning validation, see ISO 3534-1; ISO 5725-1 and ISO 16140-1.