AS 16140.3:2022

AS 16140.3, 1st, 2022 – Microbiology of the food chain – Method validation, Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory (ISO 16140-3:2021, MOD)

AS 16140.3 was prepared by the Standards Australia Committee FT-035, Food Microbiology. The objective of this document is to specify the protocol for the verification of reference methods and validated alternative methods for implementation in the user laboratory.
This document is applicable to the verification of methods used for the analysis (detection and/or quantification), confirmation and typing of microorganisms in —

(a) products intended for human consumption;

(b) products intended for animal feeding;

(c) environmental samples in the area of food and feed production, handling;

(d) samples from the primary production stage.

This document is, in particular, applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms or their metabolites, to be determined on a case-by-case basis.
The technical protocols for the verification of validated qualitative methods and validated quantitative methods are described in Clauses 5 and 6. The technical protocol for the verification of validated alternative confirmation and typing methods is described in Clause 7. The protocols for the verification of non-validated reference methods are described in Annex F.

This document is an adoption with national modifications, and has been reproduced from, ISO 16140-3:2021, Microbiology of the food chain — Method validation — Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory. The modifications are additional requirements and are set out in Appendix ZZ, which has been added at the end of the source text.
Appendix ZZ lists the modifications to ISO 16140‑3:2021, for the application of this document
in Australia.
As this document has been reproduced from an International document, a full point substitutes for a comma when referring to a decimal marker. Australian or Australian/New Zealand Standards that are identical adoptions of international normative references may be used interchangeably. Refer to the online catalogue for information on specific Standards.
The terms “normative” and “informative” are used in Standards to define the application of the appendices or annexes to which they apply. A “normative” appendix or annex is an integral part of a Standard, whereas an “informative” appendix or annex is only for information and guidance.

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