This procedure specifies a test method and the minimum requirements for bactericidal activity of teat disinfectants that form a homogeneous, physically stable preparation when diluted with hard water - or in the case of ready-to-use products - with water.
This method applies to teat disinfectants that are used in the veterinary area on teat skin without mechanical action as pre-milking and/or post-milking teat disinfectants.
NOTE 1 The method described is intended to determine the activity of commercial formulations under the conditions in which they are used.
NOTE 2 This method corresponds to a phase 2 step 2 test.
NOTE 3 Two types of synthetic skin were assessed in a ring trial with no significant difference in performance. Other synthetic skins may become available and may be used if it can be shown that they give comparable results to the two referenced in this standard.

  • Standard
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This document describes general workflows and protocols for the validation and the verification
of qualitative screening tests for the detection of residues of veterinary drugs in liquid milk (raw,
pasteurized, UHT and reconstituted milk powders and whey protein extracts) including biological
methods. This guideline does not cover the validation of residue analysis by HPLC, UHPLC or LC-MS/MS.
This document is intended to be useful for manufacturers of screening test kits, laboratories validating
screening methods or tests, competent authorities and dairies or end users of reagents or tests for the
detection of veterinary drug residues in milk products. This document facilitates and improves the
validation and verification of screening methods. The goals of this document are a harmonization in
validation of methods or test kits in order for all stakeholders to have full trust in the result of residue
screening and to limit the overlap and multiplication of validation work in different laboratories by
sharing the validation results generated by an independent laboratory. Furthermore, a harmonized
validation and verification procedure allows for comparison of the performance of different screening
methods.
This document does not imply that all end users are bound to perform all verification work proposed.
The verification of the correct use of reagents/kits for the detection of antimicrobials is not part of the
scope of this document.

  • Technical specification
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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.

  • Standard
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EN 16437:2014+A1 specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectants 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 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”.

  • Standard
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This European Standard specifies a test method and the minimum requirements for bactericidal 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. Products can only be tested at a concentration of 80 % or less, as some dilution is always produced by adding the test organisms and interfering substance.
This European Standard applies to products that are used in the veterinary area - e.g. in the breeding, husbandry, 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 1 test.

  • Standard
    40 pages
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This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal 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. Products can only be tested at a concentration of 80 % or less, as some dilution is always produced by adding the test organisms and interfering substance.
This European Standard applies to products that are used in the veterinary area - i.e. in the breeding, husbandry, production, 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 1 test (Annex F).

  • Standard
    45 pages
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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. Products can only be tested at a concentration of 80 % or less as some dilution is always produced by adding the test organisms and interfering substance.This European Standard applies to products that are used in the veterinary area i.e. in the breeding, husbandry, production, transport and disposal of all animals except when in the food chain following death and entry to the processing industry. NOTE 1 The method described is intended to determine the virucidal 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 1 test (Annex E).

  • Standard
    34 pages
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EN 16438 specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant and antiseptic products that form a homogeneous physically stable preparation in hard water or - in the case of ready-to-use products- with water. This European Standard applies to products for use in the veterinary area i.e. in the breeding, husbandry, production, 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".

  • Standard
    39 pages
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This European Standard specifies a test method and the minimum requirements for bactericidal 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, 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 This method cannot be used to evaluate the activity of products against mycobacteria.

  • Standard
    36 pages
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This European Standard specifies a test method and the minimum requirements for mycobactericidal 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.  Products can only be tested at a concentration of 80 % or less, as some dilution is always produced by adding the test organisms and interfering substance. This European Standard applies to products that are used in the veterinary area - i.e. in the breeding, husbandry, production, 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 1 test.

  • Standard
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This document specifies a common data exchange format (i.e., format of the messages and the dictionary of all the items that compose the message) between the prescribers and the laboratories in the animal health sector.
This document is intended for prescribers (purchasers) and service providers in charge of collecting samples and conducting analyses (including analysis laboratories) that want to computerize and standardize their data exchanges, particularly in the animal health sector.
This document excludes the code lists that are required for unambiguous data exchange.

  • Draft
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The level of requirements presented in the EN 18000 series has been established as a priority for infectious diseases (bacterial, viral, fungal or parasitic) and associated animal species for which harmonization of practices in this area is needed, i.e. those for which the national, regional or international regulatory framework provides for the control of trade in animals and/or animal products and/or the definition of a health status (absence of infection) of areas, establishments or individuals.
The EN 18000 series is therefore not intended to be applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this standard cannot be validly evaluated in accordance with international requirements, due e.g. to the absence of a specific reference standard and/or accessible and duly validated reference materials.
This second part describes the control, in the above-described framework, of in vitro reagents for immunological analyses with a qualitative expression of results used in animal health. It involves control organizations (CO) and applicants (including their subcontractors, when relevant).

  • Draft
    14 pages
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The level of requirements presented in the EN 18000 series has been established as a priority for infectious diseases (bacterial, viral, fungal or parasitic) and associated animal species for which harmonization of practices in this area is necessary, i.e. those for which the national, regional or international regulatory framework provides for the control of trade in animals and/or animal products and/or the definition of a health status (absence of infection) of areas, establishments or individuals.
The EN 18000 series is therefore not intended to be applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this standard cannot be validly evaluated in accordance with international requirements due, e.g. to the absence of a specific reference method and/or accessible and duly validated reference materials.
This first part describes the general and specific elements constituting the dossier for the submission of an animal health in vitro diagnostic reagent, in the above-described framework, to the control and approval by a control organization. Its purpose is to provide the applicant submitting an animal disease in vitro diagnostic reagent to control with the general input for the preparation of the control application file. It describes the optimal administrative and technical information regarding the applicant and the reagent required for the application file for initial control and for a batch-to-batch control respectively. It specifies, in particular, the validation parameters of the method using the reagent (objectives, methodology, criteria and results) according to international standards.
NOTE   This document does not cover the step in which the user verifies a reagent (refer to section 3.1 for definition).

  • Draft
    31 pages
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This document specifies a test method and the minimum requirements for mycobactericidal 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.
Products can only be tested at a concentration of 80 % or less, as some dilution is always produced by adding the test organisms and interfering substance.
The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
This document applies to products that are used for equipment disinfection by immersion, surface disinfection by wiping, spraying or flooding or other means and teat disinfection in the veterinary area - 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".

  • Draft
    35 pages
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This document specifies a common data exchange format (i.e., format of the messages and the dictionary of all the items that compose the message) between the prescribers and the laboratories in the animal health sector.
This document is intended for prescribers (purchasers) and service providers in charge of collecting samples and conducting analyses (including analysis laboratories) that want to computerize and standardize their data exchanges, particularly in the animal health sector.
This document excludes the code lists that are required for unambiguous data exchange.

  • Draft
    51 pages
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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.

  • Draft
    6 pages
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The level of requirements presented in the EN 18000 series has been established as a priority for infectious diseases (bacterial, viral, fungal or parasitic) and associated animal species for which harmonization of practices in this area is needed, i.e. those for which the national, regional or international regulatory framework provides for the control of trade in animals and/or animal products and/or the definition of a health status (absence of infection) of areas, establishments or individuals.
The EN 18000 series is therefore not intended to be applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this standard cannot be validly evaluated in accordance with international requirements, due e.g. to the absence of a specific reference standard and/or accessible and duly validated reference materials.
This second part describes the control, in the above-described framework, of in vitro reagents for immunological analyses with a qualitative expression of results used in animal health. It involves control organizations (CO) and applicants (including their subcontractors, when relevant).

  • Draft
    14 pages
    English language
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The level of requirements presented in the EN 18000 series has been established as a priority for infectious diseases (bacterial, viral, fungal or parasitic) and associated animal species for which harmonization of practices in this area is necessary, i.e. those for which the national, regional or international regulatory framework provides for the control of trade in animals and/or animal products and/or the definition of a health status (absence of infection) of areas, establishments or individuals.
The EN 18000 series is therefore not intended to be applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this standard cannot be validly evaluated in accordance with international requirements due, e.g. to the absence of a specific reference method and/or accessible and duly validated reference materials.
This first part describes the general and specific elements constituting the dossier for the submission of an animal health in vitro diagnostic reagent, in the above-described framework, to the control and approval by a control organization. Its purpose is to provide the applicant submitting an animal disease in vitro diagnostic reagent to control with the general input for the preparation of the control application file. It describes the optimal administrative and technical information regarding the applicant and the reagent required for the application file for initial control and for a batch-to-batch control respectively. It specifies, in particular, the validation parameters of the method using the reagent (objectives, methodology, criteria and results) according to international standards.
NOTE   This document does not cover the step in which the user verifies a reagent (refer to section 3.1 for definition).

  • Draft
    31 pages
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This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal 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. Products can only be tested at a concentration of 80 % or less, as some dilution is always produced by adding the test organisms and interfering substance.
This European Standard applies to products that are used in the veterinary area - i.e. in the breeding, husbandry, production, 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 1 test (Annex F).

  • Draft
    44 pages
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This European Standard specifies a test method and the minimum requirements for bactericidal 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, 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   This method cannot be used to evaluate the activity of products against mycobacteria.

  • Draft
    37 pages
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This European Standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectants 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 porous surfaces without mechanical action i.e. in the breeding, husbandry, production, transport, veterinary care facilities 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    This method cannot be used to evaluate the activity of products against mycobacteria or bacterial spores.

  • Draft
    4 pages
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EN 16437 specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectants 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 porous surfaces without mechanical action i.e. in the breeding, husbandry, production, 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".

  • Standard
    37 pages
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This European Standard specifies a test method and the minimum requirements for bactericidal 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. Products can only be tested at a concentration of 80 % or less, as some dilution is always produced by adding the test organisms and interfering substance. This European Standard applies to products that are used in the veterinary area - e.g. in the breeding, husbandry, 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".

  • Corrigendum
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This European Standard specifies a test method and the minimum requirements for bactericidal 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. Products can only be tested at a concentration of 80 % or less, as some dilution is always produced by adding the test organisms and interfering substance.
This European Standard document applies to products that are used in the veterinary area – e.g. in the breeding, husbandry, 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 1 test.

  • Standard
    37 pages
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This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal 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. Products can only be tested at a concentration of 80 percent or less, as some dilution is always produced by adding the test organisms and interfering substance.
This European Standard applies to products that are used in the veterinary area - i.e. in the breeding, husbandry, production, transport and disposal of all animals except when in the food chain following death and entry to the processing industry.
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 1 test (Annex F).

  • Standard
    43 pages
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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. Products can only be tested at a concentration of 80 % or less as some dilution is always produced by adding the test organisms and interfering substance.
This European Standard applies to products that are used in the veterinary field i.e. in the breeding, husbandry, production, transport and disposal of all animals except when in the food chain following death and entry to the processing industry.
NOTE 1   The method described is intended to determine the virucidal 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 1 test (Annex E).

  • Standard
    28 pages
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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. Products can only be tested at a concentration of 80 % or less as some dilution is always produced by adding the test organisms and interfering substance.
This European Standard applies to products that are used in the veterinary field i.e. in the breeding, husbandry, production, transport and disposal of all animals except when in the food chain following death and entry to the processing industry.
NOTE 1   The method described is intended to determine the virucidal 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 1 test (Annex E).

  • Standard
    28 pages
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This European Standard specifies a test method and the minimum requirements for bactericidal 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 is applicable to products for use in the veterinary area i.e. in the breeding, husbandry, production, transport and disposal of all animals except when in the food chain following death and entry to the processing industry.
NOTE 1   Mycobacteria are the subject of a separate standard.
NOTE 2   This method corresponds to a Phase 2 Step 2 test (Annex E).

  • Standard
    24 pages
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This European Standard specifies a test method and the minimum requirements for mycobactericidal 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. Products can only be tested
at a concentration of 80 % or less, as some dilution is always produced by adding the test organisms and
interfering substance.
This European Standard applies to products that are used in the veterinary area i.e. in the breeding,
husbandry, production, transport and disposal of all animals except when in the food chain following death
and entry to the processing industry.
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 1 test (Annex F).

  • Standard
    27 pages
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This European standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant and antiseptic products that form an homogenous physically stable preparation in standardised hard water. This European Standard is applicable to products for use in the veterinary field i.e. in the breeding, husbandry, production, transport and disposal of all animals except when in the food chain following death and entry to the processing industry.

  • Standard
    31 pages
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This document specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant and antiseptic products that form a homogeneous physically stable preparation in hard water or - in the case of ready-to-use - with water.
This document is applicable to products for use in the veterinary field i.e. in the breeding, husbandry, production, transport and disposal of all animals except when in the food chain following death and entry to the processing industry.
NOTE 1   Mycobacteria are the subject of a separate standard.
NOTE 2   This method corresponds to a Phase 2 Step 2 test (Annex E).

  • Standard
    26 pages
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This European standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant and antiseptic products that form an homogenous physically stable preparation in standardised hard water. This European Standard is applicable to products for use in the veterinary field i.e. in the breeding, husbandry, production, transport and disposal of all animals except when in the food chain following death and entry to the processing industry.

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