ISO 11133-2014 amd2-2020 PDF

Full title and description

ISO 11133:2014/Amd 2:2020 — Microbiology of food, animal feed and water — Preparation, production, storage and performance testing of culture media — Amendment 2. This amendment adds normative guidance for performance testing of confirmation/characterization media and reagents and updates references to suitable test organisms used in routine performance testing.

Abstract

Amendment 2 (2020) to ISO 11133:2014 introduces a new normative annex (Annex K) that specifies control strains and procedures for the performance testing of confirmation media, reagents, dyes, stains and related materials used in ISO methods for food, feed and water microbiology. The amendment updates clause cross-references to include Annex K among sources of suitable test organisms and clarifies aspects of routine performance testing to improve harmonization and reproducibility of culture‑based methods.

General information

• Status: Published / In force
• Publication date: 11 May 2020
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 07.100.20 (Microbiology of water); 07.100.30 (Food microbiology)
• Edition / version: Amendment 2 to ISO 11133:2014 (Edition 1 of the amendment, 2020)
• Number of pages: 13

Scope

This amendment applies to ISO 11133:2014 and extends the standard for the preparation, production, storage and performance testing of culture media by adding normative requirements for the performance testing of confirmation and characterization media and reagents. It specifies test organisms (control strains) and related procedural guidance to be used when evaluating the qualitative performance of confirmation media and associated reagents within food, animal feed and water microbiology methods.

Key topics and requirements

• Addition of Annex K (normative): lists control strains and expected reactions for performance testing of confirmation/characterization media, reagents, dyes and stains.
• Specification of test organism selection: preference for strains cited in ISO 11133 or from recognized collections; provision of alternative strain options and reference to catalogues when necessary.
• Qualitative performance testing guidance: use of subcultures of isolated colonies as inocula for confirmation media; recommended incubation-time approach (shortest permissible time for positive controls, longest for negative controls) for qualitative checks.
• Updates to clause references (e.g., additions to 5.2, 5.4.1, 6.6.1, 6.6.2) to include Annex K as a source of suitable test organisms for routine performance testing.
• Guidance on interaction with organism‑specific standards and manufacturer or national requirements — where organism‑specific ISO methods or national regulations prescribe control strains, those provisions take precedence.

Typical use and users

Microbiology laboratories in the food, animal feed and water sectors (both routine testing and research); manufacturers of culture media, diagnostic reagents and test kits who require validated performance testing protocols; accreditation and quality assurance personnel; regulators and standards developers who incorporate or reference culture‑media performance criteria in method standards.

Related standards

ISO 11133:2014 (base standard); ISO 11133:2014/Amd 1:2018; ongoing revision work under ISO/DIS 11133 (revision of ISO 11133); organism‑specific ISO methods referenced for confirmation and detection (examples include various ISO standards for Salmonella, Campylobacter, Listeria, etc.). Regional/adopted versions include EN ISO 11133:2014/A2:2020 (identical adoption).

Keywords

ISO 11133, culture media, performance testing, confirmation media, control strains, reagents, food microbiology, water microbiology, Annex K, standard amendment

FAQ

Q: What is this standard?

A: ISO 11133:2014/Amd 2:2020 is Amendment 2 to ISO 11133:2014, providing additional normative requirements and guidance for performance testing of confirmation/characterization media and reagents used in food, feed and water microbiology.

Q: What does it cover?

A: It adds Annex K (normative) specifying control strains and expected reactions for performance testing, clarifies which organisms to use for routine performance testing, and updates clause references so Annex K is included among sources of suitable test organisms.

Q: Who typically uses it?

A: Microbiology testing laboratories, culture‑media and reagent manufacturers, accreditation bodies, regulatory laboratories, and standards writers or method developers in food, feed and water microbiology.

Q: Is it current or superseded?

A: The amendment was published on 11 May 2020 and is an official amendment to ISO 11133:2014. It remains the published amendment; users should also check for any later revisions of ISO 11133 or replacement documents (work to revise ISO 11133 has been under development) when planning long‑term compliance.

Q: Is it part of a series?

A: Yes — it is an amendment to the ISO 11133 series (the 2014 base standard and earlier related technical specifications). The ISO 11133 suite sits alongside organism‑specific ISO methods used for detection, confirmation and enumeration in food, feed and water microbiology.

Q: What are the key keywords?

A: Culture media, performance testing, confirmation media, control strains, reagents, food microbiology, water microbiology, ISO 11133, Annex K.