SIST EN 17122:2020/kFprA1:2024

Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of virucidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements - Phase2, step2

This European Standard specifies a test method and the minimum requirements for virucidal activity of chemical disinfectant and antiseptic products that form a homogeneous physically stable preparation when diluted with hard water, or - in the case of ready-to-use-products - with water.
This European Standard applies to products that are used in the veterinary area on non-porous surfaces without mechanical action i.e. in the breeding, husbandry, production, veterinary care facilities, transport and disposal of all animals except when in the food chain following death and entry to the processing industry.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
NOTE 1   The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
NOTE 2   This method corresponds to a Phase 2 Step 2 test.
NOTE 3   Using this European Standard, it is possible to determine the virucidal activity of the undiluted product.
NOTE 4   This standard uses Porcine Parvovirus because Bovine Enterovirus Type 1 (ECBO) virus used in the suspension test EN 14675 cannot be used for surface testing because of its loss of titre during drying. Porcine
Parvovirus has comparable resistance to ECBO virus.

Chemische Desinfektionsmittel und Antiseptika - Quantitativer Oberflächenversuch zur Bestimmung der viruziden Wirkung chemischer Desinfektionsmittel und Antiseptika für den Veterinärbereich auf nicht-porösen Oberflächen - Prüfverfahren und Anforderungen - Phase 2, Stufe 2

Antiseptiques et désinfectants chimiques - Essai quantitatif de surfaces non poreuses pour l'évaluation de l'activité virucide des désinfectants et antiseptiques chimiques utilisés dans le domaine vétérinaire - Méthode d'essai et prescriptions - Phase 2,

Kemična razkužila in antiseptiki - Kvantitativni preskus na neporoznih površinah za vrednotenje virucidnega delovanja kemičnih razkužil in antiseptikov v veterini - Preskusna metoda in zahteve (faza 2, stopnja 2) - Dopolnilo A1

General Information

• Status: Not Published
• Public Enquiry End Date: 01-Jan-2024
• ICS: 11.080.20 - Disinfectants and antiseptics
• ICS: 11.220 - Veterinary medicine
• Technical Committee: KDS - Cosmetics, chemical disinfectants and surface active agents
• Current Stage: 98 - Abandoned project (Adopted Project)
• Start Date: 04-Feb-2025
• Due Date: 09-Feb-2025
• Completion Date: 04-Feb-2025
• Ref Project: EN 17122:2019/FprA1 - Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of virucidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements - Phase2, step2

Relations

• Consolidated By: SIST EN 17122:2020+A1:2025 - Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of virucidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements - Phase2, step2
• Effective Date: 01-Mar-2025
• Revises: SIST EN 17122:2020 - Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of virucidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 2)
• Effective Date: 01-Dec-2023

Overview

EN 17122:2019/FprA1 - published by CEN - is a European test standard for assessing the virucidal activity of chemical disinfectants and antiseptics used in the veterinary area. It specifies a quantitative non-porous surface test (Phase 2, step 2) and the minimum procedural requirements for products that form a homogeneous, physically stable preparation when diluted with hard water or used ready-to-use. The method is intended to determine product activity under conditions representative of actual use and can be applied to undiluted formulations.

Key points:

• Focus: virucidal efficacy on non-porous surfaces without mechanical action (breeding, husbandry, veterinary care, transport, disposal of animals).
• Test organism: Porcine Parvovirus is used for surface testing because it has resistance comparable to Bovine Enterovirus Type 1 (ECBO), which cannot be used for surface drying tests.
• Amendment FprA1 harmonises terminology and minor editorial/technical corrections without affecting previous test results.

Key Topics and Requirements

• Quantitative surface test procedure (Phase 2, step 2): defines inoculation, drying, contact time and recovery steps for virus on non-porous surfaces.
• Measurement of virucidal activity: comparison of treated versus untreated virus titres to quantify reduction in infectivity.
• Large-Volume-Plating (LVP) method (Annex B): prescribed special technique where cytotoxicity prevents measurement by standard titration. Includes Poisson and Taylor-based calculations to estimate residual virus titres.
• Experimental controls and reporting: requires appropriate controls (cytotoxicity, neutralisation, recovery) and detailed test-report items (including drying conditions and viral strain/passages).
• Technical corrections in FprA1: examples include replacing a filter pore size value (0.44 µm → 0.45 µm), addition of EN 10088-1 reference, and removal of ambiguous wording (e.g., replacing “full virucidal” with “virucidal activity”).

Applications and Users

Who uses EN 17122:2019/FprA1:

• Veterinary disinfectant manufacturers - to generate efficacy data for product claims and label claims.
• Independent testing laboratories - to perform standardised surface virucidal testing according to CEN methodology.
• Regulatory and certification bodies - for evaluation, approval and listing of veterinary disinfectants.
• Biosecurity managers and veterinarians - to interpret efficacy evidence for selection of disinfectants in clinics, farms, transport and animal housing.

Practical benefits:

• Provides reproducible, quantitative virucidal data relevant to real-world veterinary surface disinfection.
• Enables comparison between products and supports compliance with use recommendations (EN 14885).

Related Standards

• EN 14885 (relationship of tests/use recommendations)
• EN 14675 (suspension test - references to ECBO)
• EN 10088-1 (stainless steels) - added normative reference in FprA1

Keywords: EN 17122:2019/FprA1, virucidal activity, veterinary disinfectants, non-porous surface test, Phase 2 step 2, Porcine Parvovirus, LVP method, CEN.

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 17122:2020/oprA1:2023
01-december-2023
Kemična razkužila in antiseptiki - Kvantitativni preskus na neporoznih površinah
za vrednotenje virucidnega delovanja kemičnih razkužil in antiseptikov v veterini -
Preskusna metoda in zahteve (faza 2, stopnja 2) - Dopolnilo A1
Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the
evaluation of virucidal activity of chemical disinfectants and antiseptics used in the
veterinary area - Test method and requirements - Phase2, step2
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Oberflächenversuch zur
Bestimmung der viruziden Wirkung chemischer Desinfektionsmittel und Antiseptika für
den Veterinärbereich auf nicht-porösen Oberflächen - Prüfverfahren und Anforderungen
- Phase 2, Stufe 2
Antiseptiques et désinfectants chimiques - Essai quantitatif de surfaces non poreuses
pour l'évaluation de l'activité virucide des désinfectants et antiseptiques chimiques
utilisés dans le domaine vétérinaire - Méthode d'essai et prescriptions - Phase 2,
Ta slovenski standard je istoveten z: EN 17122:2019/prA1
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
11.220 Veterinarstvo Veterinary medicine
SIST EN 17122:2020/oprA1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

SIST EN 17122:2020/oprA1:2023
SIST EN 17122:2020/oprA1:2023
DRAFT
EUROPEAN STANDARD
EN 17122:2019
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
February 2023
ICS 11.080.20
English Version
Chemical disinfectants and antiseptics - Quantitative non-
porous surface test for the evaluation of virucidal activity
of chemical disinfectants and antiseptics used in the
veterinary area - Test method and requirements - Phase2,
step2
Antiseptiques et désinfectants chimiques - Essai Chemische Desinfektionsmittel und Antiseptika -
quantitatif de surfaces non poreuses pour l'évaluation Quantitativer Oberflächenversuch zur Bestimmung der
de l'activité virucide des désinfectants et antiseptiques viruziden Wirkung chemischer Desinfektionsmittel
chimiques utilisés dans le domaine vétérinaire - und Antiseptika für den Veterinärbereich auf nicht-
Méthode d'essai et prescriptions - Phase 2, porösen Oberflächen - Prüfverfahren und
Anforderungen - Phase 2, Stufe 2
This draft amendment is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 216.

This draft amendment A1, if approved, will modify the European Standard EN 17122:2019. If this draft becomes an amendment,
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.

This draft amendment was established by CEN 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.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 17122:2019/prA1:2023 E
worldwide for CEN national Members.

SIST EN 17122:2020/oprA1:2023
EN 17122:2019/prA1:2023 (E)
European foreword
This document (EN 17122:2019/prA1:2023) has been prepared by Technical Committee CEN/TC 216 “Chemical
disinfectants and antiseptics”, the secretariat of which is held by AFNOR.
This document is currently submitted to the CEN Enquiry.

SIST EN 17122:2020/oprA1:2023
EN 17122:2019/prA1:2023 (E)
1 Modification to the European foreword
After the third paragraph, add the following new paragraph:
“This document has been amended to harmonise the terminology and methods with those adopted recently for
other similar European standards and to make minor editorial changes to improve clarity. A minor technical error
has also been corrected. The changes detailed above have no impact on the test results obtained using the previous
version. Those results are still valid.”
2 Modification to Contents
Change the entry for Annex B to “Annex B Determination of the residual virus titre by the large-volume- plating
(LVP) method”
Change the Title of Annex E to “Virucidal activity and activity against enveloped viruses”
3 Modification to Clause 2, Normative References
Add, between the references to EN 14885 and EN 10088-2:
“EN 10088-1, Stainless steels — Part 1: List of stainless steels”
4 Modification to Clause 4, Requirements for virucidal activity on surfaces
Delete the word “full” in the second sentence of the first paragraph, in the note and in the heading of Table 1.
5 Modification to 5.2.2.4, Neutral Red (1:1000 solution)
Replace “0,44 µm” with “0,45 µm”.
6 Modification to 5.5.1, Experimental conditions
Delete the word “full” in the second sentence of clause c.
7 Modification to 5.5.2, Test procedure
Change the sub-heading a to “a) Quantal tests (end point titration) – [the procedures 1) and 2) are alternatives]”
8 Modification to 5.5.3.3, Elimination of cytotoxicity
Delete the whole text of this subclause and replace with:
“If the cytotoxicity is so great that the reduction (5.8.2) cannot demonstrate the range of 3 lg TCID ,
50 special
techniques shall be used, such as determination of the residual virus titre by the large-volume- plating (LVP)
method (Annex B).
Appropriate controls are required to demonstrate that the procedure does not reduce the infectivity of the virus.
The virucidal activity is measured by comparing the titres of the treated and untreated viral suspensions. Use
according to th
...