EN ISO 18744:2016/A1:2026
(Amendment)Microbiology of the food chain - Detection and enumeration of Cryptosporidium and Giardia in fresh leafy green vegetables and berry fruits - Amendment 1: Method validation studies and performance characteristics (ISO 18744:2016/Amd 1:2026)
- Status
- Published
- Publication Date
- 07-Jul-2026
- Technical Committee
- CEN/TC 463 - Microbiology of the food chain
- Drafting Committee
- CEN/TC 463 - Microbiology of the food chain
- Current Stage
- 6060 - Definitive text made available (DAV) - Publishing
- Start Date
- 08-Jul-2026
- Completion Date
- 08-Jul-2026
EN ISO 18744:2016/A1:2026 is a CEN amendment to the European Standard for detecting and enumerating Cryptosporidium and Giardia in fresh leafy green vegetables and berry fruits. It adds method validation studies and performance characteristics, updates the linked microbiology reference to ISO 7218:2024, and clarifies how laboratories handle the method and report results.
What does EN ISO 18744:2016/A1:2026 specify?
EN ISO 18744:2016/A1:2026 modifies EN ISO 18744:2016 for testing fresh leafy green vegetables and berry fruits. It keeps the document focused on detection and enumeration of Cryptosporidium and Giardia, while adding an informative Annex D on validation data and performance characteristics.
| Annex | What it covers |
|---|---|
| D (informative) | Method validation studies and performance characteristics, based on interlaboratory data |
The amendment is organized as a set of targeted changes to the main standard, followed by the new Annex D and a bibliography update. In practice, readers use it to see what has changed in the method, what performance data support it, and how those results should be reported.
What are the key requirements of EN ISO 18744:2016/A1:2026?
The amendment makes several practical changes that affect day-to-day laboratory work.
- Clause 2 replaces ISO 7218:2007 with ISO 7218:2024. This matters because the general microbiology rules now point to the updated reference document.
- Clause 6 and Clauses 7.2, 7.3 and 7.4 now require work to be carried out in accordance with ISO 7218:2024, with specific subclauses 9.2, 9.3 and 9.4 cited where relevant. In practice, the test workflow must follow the newer general microbiology practices.
- Clauses 8.1 and 8.2 specify centrifuging the eluate at 2 500g for 10 min with no braking. The notes say that 1 100g for 10 min with no braking has been reported to give at least equivalent recoveries, which is useful when a laboratory is checking recovery or optimizing equipment.
- Clause 8.5.2.2, Note 1 adds that some Cryptosporidium species can reach 8 μm, including C. andersoni and C. muris. This helps analysts avoid misjudging larger species during microscopic identification, especially where human health relevance may be considered.
- Clause 10.1 states that results should be given as the presence or absence of Cryptosporidium oocysts and/or Giardia cysts detected per weight of fresh produce examined. That tells laboratories how to express the result for a sample batch.
- Clause 10.2 i) adds that reports should include the presence or absence of both targets and relevant identification and verification details such as size, DAPI-staining, and morphological details. This matters for traceability and for supporting the analyst’s conclusion.
- Annex D provides method validation studies and performance characteristics. It gives the background to the interlaboratory studies and the statistics used to describe reproducibility and detection performance.
What terms does EN ISO 18744:2016/A1:2026 define?
The amendment uses several terms that are central to the method.
- Cryptosporidium - a parasite genus targeted by the method in fresh produce.
- Giardia - the other parasite genus targeted by the method.
- Oocysts - the environmental form of Cryptosporidium that the method detects and enumerates.
- Cysts - the environmental form of Giardia that the method detects and enumerates.
- DAPI-staining - a verification feature mentioned in reporting, used as part of identification checks.
- LOD - the limit of detection discussed in Annex D as a performance characteristic.
- ICC - the intraclass correlation coefficient, used in Annex D to describe between-laboratory variation.
Who uses EN ISO 18744:2016/A1:2026?
EN ISO 18744:2016/A1:2026 is used by food microbiology laboratories, validation teams, and quality managers working with fresh leafy green vegetables and berry fruits. It is also relevant to buyers and technical specifiers who need laboratory evidence for parasite testing, and to accreditation or audit teams reviewing how the method is applied and reported.
What changed in EN ISO 18744:2016/A1:2026 from the previous edition?
This amendment modifies EN ISO 18744:2016 in several ways:
- it updates the general reference from ISO 7218:2007 to ISO 7218:2024;
- it aligns Clauses 6 and 7.2 to 7.4 with ISO 7218:2024;
- it clarifies centrifugation conditions and notes an alternative lower-speed setting with reported equivalent recoveries;
- it adds a reporting requirement for result expression and identification details;
- it adds Annex D with validation studies and performance characteristics;
- it expands the note on larger Cryptosporidium species.
Which standards are used with EN ISO 18744:2016/A1:2026?
The amendment directly uses ISO 7218:2024 for general microbiology requirements in Clause 6 and Clauses 7.2 to 7.4. Annex D also mentions ISO 16140-2:2016, Annex F, as the generally recommended model reference for one of the validation analyses.
What does the EN ISO 18744:2016/A1:2026 document contain?
The document contains amendment instructions for specific clauses, a new informative Annex D, and an updated bibliography entry. Annex D summarizes interlaboratory studies on Webb’s lettuce and raspberries for Cryptosporidium, and on Webb’s lettuce for Giardia.
It includes tables for specificity, sensitivity by contamination level, LOD, standard deviation of laboratory effects, and ICC. It also includes figures showing per cent positive recovery across laboratories at each spike level. For users, this section is the practical evidence base for method validation, reproducibility review, and interpretation of performance characteristics.
Relations
- Effective Date
- 12-Feb-2026
- Effective Date
- 31-Jul-2024
Frequently Asked Questions
EN ISO 18744:2016/A1:2026 is a amendment published by the European Committee for Standardization (CEN). Its full title is "Microbiology of the food chain - Detection and enumeration of Cryptosporidium and Giardia in fresh leafy green vegetables and berry fruits - Amendment 1: Method validation studies and performance characteristics (ISO 18744:2016/Amd 1:2026)". This standard covers: No scope available
No scope available
EN ISO 18744:2016/A1:2026 is classified under the following ICS (International Classification for Standards) categories: 07.100.30 - Food microbiology. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 18744:2016/A1:2026 has the following relationships with other standards: It is inter standard links to ISO 18744:2016/Amd 1:2026, EN ISO 18744:2016. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 18744:2016/A1:2026 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2026
Mikrobiologija v prehranski verigi - Ugotavljanje prisotnosti in števila
"Cryptosporidium" in "Giardia" v sveži zeleni listnati zelenjavi in jagodičju -
Dopolnilo A1: Študije validacije metode in značilnosti delovanja (ISO
18744:2016/Amd 1:2026)
Microbiology of the food chain - Detection and enumeration of Cryptosporidium and
Giardia in fresh leafy green vegetables and berry fruits - Amendment 1: Method
validation studies and performance characteristics (ISO 18744:2016/Amd 1:2026)
Mikrobiologie der Lebensmittelkette - Nachweis und Zählung von Cryptosporidium und
Giardia in frischem grünem Blattgemüse und Beeren - Änderung 1 (ISO
18744:2016/Amd 1:2026)
Microbiologie de la chaîne alimentaire - Recherche et dénombrement de
Cryptosporidium et Giardia dans les légumes verts frais à feuilles et les fruits à baies -
Amendement 1: Études de validation des méthodes et caractéristiques de performance
(ISO 18744:2016/Amd 1:2026)
Ta slovenski standard je istoveten z: EN ISO 18744:2016/A1:2026
ICS:
07.100.30 Mikrobiologija živil Food microbiology
67.080.01 Sadje, zelenjava in njuni Fruits, vegetables and
proizvodi na splošno derived products in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 18744:2016/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2026
EUROPÄISCHE NORM
ICS 07.100.30
English Version
Microbiology of the food chain - Detection and
enumeration of Cryptosporidium and Giardia in fresh leafy
green vegetables and berry fruits - Amendment 1: Method
validation studies and performance characteristics (ISO
18744:2016/Amd 1:2026)
Microbiologie de la chaîne alimentaire - Recherche et Mikrobiologie der Lebensmittelkette - Nachweis und
dénombrement de Cryptosporidium et Giardia dans les Zählung von Cryptosporidium und Giardia in frischem
légumes verts frais à feuilles et les fruits à baies - grünem Blattgemüse und Beeren - Änderung 1:
Amendement 1: Études de validation des méthodes et Verfahrensvalidierungsstudien und
caractéristiques de performance (ISO Leistungsmerkmale (ISO 18744:2016/Amd 1:2026)
18744:2016/Amd 1:2026)
This amendment A1 modifies the European Standard EN ISO 18744:2016; it was approved by CEN on 1 July 2026.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18744:2016/A1:2026 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 18744:2016/A1:2026) has been prepared by Technical Committee ISO/TC 34
"Food products" in collaboration with Technical Committee CEN/TC 463 “Microbiology of the food
chain” the secretariat of which is held by AFNOR.
This Amendment to the European Standard EN ISO 18744:2016 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by January 2027, and
conflicting national standards shall be withdrawn at the latest by January 2027.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 18744:2016/Amd 1:2026 has been approved by CEN as EN ISO 18744:2016/A1:2026
without any modification.
International
Standard
ISO 18744
First edition
Microbiology of the food chain —
2016-04-01
Detection and enumeration of
Cryptosporidium and Giardia in
AMENDMENT 1
fresh leafy green vegetables and
2026-06
berry fruits
AMENDMENT 1: Method validation
studies and performance
characteristics
Microbiologie de la chaîne alimentaire — Recherche et
dénombrement de Cryptosporidium et Giardia dans les
légumes verts frais à feuilles et les fruits à baies
AMENDEMENT 1: Études de validation des méthodes et
caractéristiques de performance
Reference number
ISO 18744:2016/Amd.1:2026(en) © ISO 2026
ISO 18744:2016/Amd.1:2026(en)
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 18744:2016/Amd.1:2026(en)
Foreword
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This document was prepared by Technical Committee ISO/TC 34, Food products, Subcommittee SC 9,
Microbiology, in collaboration with the European Committee for Standardization (CEN) Technical Committee
CEN/TC 463, Microbiology of the food chain, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
Any feedback or questions on this document should be directed to the user’s national standards body. A
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iii
ISO 18744:2016/Amd.1:2026(en)
Microbiology of the food chain — Detection and
enumeration of Cryptosporidium and Giardia in fresh leafy
green vegetables and berry fruits
AMENDMENT 1: Method validation studies and performance
characteristics
Contents
Add the following text after Annex C:
Annex D (informative) Method validation studies and performance characteristics
2. Normative references
Replace ISO 7218:2007 with ISO 7218:2024.
Clause 6, first sentence
Replace the text in brackets with the following:
in accordance with ISO 7218:2024
7.2, first sentence
Replace the text in brackets with the following:
in accordance with ISO 7218:2024, 9.2.
7.3, first sentence
Replace the text in brackets with the following:
in accordance with ISO 7218:2024, 9.3.
7.4, first sentence
Replace the text in brackets with the following:
in accordance with ISO 7218:2024, 9.4.
ISO 18744:2016/Amd.1:2026(en)
8.1, NOTE 1
Replace the text with the following:
Centrifugation at 2 500g can result in a very compact pellet. A lower speed
...