The method described herein is designed to determine the disinfectant activity of processes used in hospital, medical, pharmaceutical and cosmetics, veterinary, industrial and food processing areas.
The product trialled is designed to be diffused as gaseous molecules or solid or liquid-form dispersants.
NOTE Concerning automatic disinfectant processes:
the limits to use, especially in terms of ability to diffuse throughout the room (min and max effective volumes), shall be specified and stated in the test report;
certain automatic disinfection processes are only suitable for use in large-volume spaces well in excess of 150 m3.
Under these conditions, the systems cannot be tested in indoor spaces less than 150 m3 due to the high power of the jet spray; "additional experimental conditions" (see 5.5.1.1.f) should therefore be used and the tests should only be performed in test rooms with volumes different to the obligatory conditions.

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The test methods described are designed to determine the disinfectant activity of processes used in the 1) medical area, 2) veterinary area, 3) food, industrial, domestic and institutional area using automated processes for distributing chemicals by air diffusion with no operator manually applying the disinfectant. This document covers the disinfection of nonporous surfaces but not that of the air.
The objective of the described processes is to disinfect the surfaces of the overall area including the external surfaces of the equipment contained in such rooms. Air handling and products or processes specifically designed for the disinfection of medical devices are excluded from the scope of this document. The test methods and volumes described provide a defined challenge.
This document is applicable to processes for which activity is claimed against the following groups of microorganisms:
—   vegetative bacteria,
—    mycobacteria,
—   bacterial spores,
—   yeasts,
—   fungal spores,
—   viruses,
—   bacteriophages.
This document does not cover processes for which the mode of action is based on immersing and/or circulation, flooding, spraying, wiping or other processes where the product is directly applied to the surfaces and not via air dispersion.

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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.

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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.

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20191119 - Negative assessment addressed through BT decision C168/2019 (SV)
2019-03-07-JO-  under HAS assessment at PUB stage. E&Y Report was due on 03 March 2019. Awaiting for assessement report from E&Y.
2018-10-17 - TAN : Lack of compliance

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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.

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This European Standard specifies a test method (phase 2/step 2) and the minimum requirements for bactericidal and/or fungicidal or yeasticidal activity of chemical disinfectants that form a homogeneous physically stable preparation in hard water or – in the case of ready-to-use products – with water in food, industrial, domestic and institutional areas, excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues.
The scope of this European Standard applies at least to the following:
a)   Processing, distribution and retailing of:
1)   Food of animal origin:
i)   milk and milk products;
ii)   meat and meat products;
iii)   fish, seafood and products;
iv)   eggs and egg products;
v)   animal feeds;
vi)   etc.
2)   Food of vegetable origin:
i)   beverages;
ii)   fruits, vegetables and derivatives (including sugar distillery);
iii)   flour, milling and backing;
iv)   animal feeds;
v)   etc.
b)   Institutional and domestic areas:
1)   catering establishments;
2)   public areas;
3)   public transports;
4)   schools;
5)   nurseries;
6)   shops;
7)   sports rooms;
8)   waste container (bins);
9)   hotels;
10)   dwellings;
11)   clinically non sensitive areas of hospitals;
12)   offices;
13)   etc.
c)   Other industrial areas:
1)   packaging material;
2)   biotechnology (yeast, proteins, enzymes...);
3)   pharmaceutical;
4)   cosmetics and toiletries;
5)   textiles;
6)   space industry, computer industry;
7)   etc.
Using this European Standard, it is possible to determine the bactericidal or fungicidal or yeasticidal activity of the undiluted product. As three concentrations are tested, in the active to non active range, dilution of the product is required and, therefore, the product forms a homogeneous stable preparation in hard water.
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 on bacteria and/or fungi in the conditions in which they are used.
NOTE 2   This method cannot be used to evaluate the activity of products against mycobacteria.

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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, i. e, products that are not diluted when applied, with water. Products can only be tested at a concentration of 80 % (97 %, with a modified method for special cases) 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 medical area in the fields of hygienic handrub, hygienic handwash, instrument disinfection by immersion, surface disinfection by wiping, spraying, flooding or other means and textile disinfection.
This European Standard applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
-   in hospitals, in community medical facilities, and in dental institutions;
-   in clinics of schools, of kindergartens, and of nursing homes;
and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients.
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.
NOTE 3   EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".

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This European Standard specifies a test method (phase 2/step 2) and the minimum requirements for bactericidal and/or fungicidal or yeasticidal activity of chemical disinfectants that form a homogeneous physically stable preparation in hard water or – in the case of ready-to-use products – with water in food, industrial, domestic and institutional areas, excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues.
The scope of this European Standard applies at least to the following:
a)   Processing, distribution and retailing of:
1)   Food of animal origin:
i)   milk and milk products;
ii)   meat and meat products;
iii)   fish, seafood and products;
iv)   eggs and egg products;
v)   animal feeds;
vi)   etc.
2)   Food of vegetable origin:
i)   beverages;
ii)   fruits, vegetables and derivatives (including sugar distillery);
iii)   flour, milling and backing;
iv)   animal feeds;
v)   etc.
b)   Institutional and domestic areas:
1)   catering establishments;
2)   public areas;
3)   public transports;
4)   schools;
5)   nurseries;
6)   shops;
7)   sports rooms;
8)   waste container (bins);
9)   hotels;
10)   dwellings;
11)   clinically non sensitive areas of hospitals;
12)   offices;
13)   etc.
c)   Other industrial areas:
1)   packaging material;
2)   biotechnology (yeast, proteins, enzymes...);
3)   pharmaceutical;
4)   cosmetics and toiletries;
5)   textiles;
6)   space industry, computer industry;
7)   etc.
Using this European Standard, it is possible to determine the bactericidal or fungicidal or yeasticidal activity of the undiluted product. As three concentrations are tested, in the active to non active range, dilution of the product is required and, therefore, the product forms a homogeneous stable preparation in hard water.
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 on bacteria and/or fungi in the conditions in which they are used.
NOTE 2   This method cannot be used to evaluate the activity of products against mycobacteria.

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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, i. e, products that are not diluted when applied, with water. Products can only be tested at a concentration of 80 % (97 %, with a modified method for special cases) 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 medical area in the fields of hygienic handrub, hygienic handwash, instrument disinfection by immersion, surface disinfection by wiping, spraying, flooding or other means and textile disinfection.
This European Standard applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
-   in hospitals, in community medical facilities, and in dental institutions;
-   in clinics of schools, of kindergartens, and of nursing homes;
and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients.
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.
NOTE 3   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 virucidal activity of chemical 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 European Standard applies to products that are used in the medical area for disinfecting non-porous surfaces including surfaces of medical devices without mechanical action.
This European Standard applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
-   in hospitals, in community medical facilities, and in dental institutions;
-   in clinics of schools, of kindergartens, and of nursing homes;
and may occur in the workplace and in the home.
It may also include services such as laundries and kitchens supplying products directly for the patients.
NOTE 1   The method described is intended to determine the activity of commercial formulations or active substances on viruses in the conditions in which they are used.
NOTE 2   This method corresponds to a phase 2, step 2 test.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".

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This European Standard specifies a test method and the minimum requirements for sporicidal 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 (97 % with a modified method for special cases) 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 medical area in the fields of instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding or other means.
This European Standard applies to areas and situations where disinfection or antisepsis is medically indicated. Such indications occur in patient care, for example:
   in hospitals, in community medical facilities and in dental institutions;
   in clinics of schools, of kindergartens and of nursing homes;
and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients.
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.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.

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This document specifies a test method and the minimum requirements for virucidal activity of chemical 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 document applies to products that are used in the medical area for disinfecting non-porous surfaces including surfaces of medical devices without mechanical action.
This document applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
-   in hospitals, in community medical facilities, and in dental institutions;
-   in clinics of schools, of kindergartens, and of nursing homes;
and may occur in the workplace and in the home.
It may also include services such as laundries and kitchens supplying products directly for the patients.
NOTE 1   The method described is intended to determine the activity of commercial formulations or active substances on viruses in the conditions in which they are used.
NOTE 2   This method corresponds to a phase 2, step 2 test.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".

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This European Standard specifies the European Standards to which products have to conform in order to support the claims for microbicidal activity which are referred to in this European Standard.
This European Standard also specifies terms and definitions which are used in European Standards.
It is applicable to products for which activity is claimed against the following microorganisms: vegetative bacteria (including mycobacteria and Legionella), bacterial spores, yeasts, fungal spores and viruses (including bacteriophages).
It is intended to:
a)   enable manufacturers of products to select the appropriate standards to be used in order to provide data which support their claims for a specific product;
b)   enable users of the product to assess the information provided by the manufacturer in relation to the use for which they intend to use the product;
c)   assist regulatory authorities in assessing claims made by the manufacturer or by the person responsible for placing the product on the market.
It is applicable to products to be used in the area of human medicine, the veterinary area and in food, industrial, domestic and institutional areas.
In the area of human medicine, it is applicable to chemical disinfectants and antiseptics to be used in areas and situations where disinfection or antisepsis is medically indicated. Such indications occur in patient care
-   in hospitals, in community medical facilities and dental institutions,
-   in clinics of schools, of kindergartens and of nursing homes,
-   and may also occur in the workplace and in the home. It may also include services such as in laundries and kitchens supplying products directly for the patient.
In the veterinary area it is applicable to chemical disinfectants and antiseptics to be used in the areas of breeding, husbandry, veterinary care facilities, production, transport and disposal of animals. It is not applicable to chemical disinfectants used in the food chain following death and entry to the processing industry.
In food, industrial, domestic and institutional areas it is applicable to chemical disinfectants and antiseptics to be used in processing, distribution and retailing of food of animal or vegetable origin. It is also applicable to products for all public areas where disinfection is not medically indicated (homes, catering, schools, nurseries, transports, hotels, offices etc.) and products used in packaging, biotechnology, pharmaceutical, cosmetic etc. industries.
This European Standard is also applicable to active substances and products under development for which no area of application has yet been specified.
This European Standard does not refer to methods for testing the toxicological and ecotoxicological properties of products or active substances.

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This European Standard specifies a test method and the minimum requirements for virucidal activity of
chemical disinfectant 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 medical area for disinfecting instruments by immersion - even if they are not covered by the EEC/93/42 Directive on Medical Devices.
This European Standard applies to areas and situations where disinfection is medically indicated. Such
indications occur in patient care, for example:
a) in hospitals, in community medical facilities and in dental institutions;
b) in clinics of schools, of kindergartens and of nursing homes;
c) and may occur in the workplace and in the home. It may also include services such as laundries and
kitchens supplying products directly for the patients.
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.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".

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This document specifies a test method and the minimum requirements for sporicidal activity of chemical disinfectant 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 (97 % with a modified method for special cases) 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 medical area in the fields of instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding or other means.
This European Standard applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
-   in hospitals, in community medical facilities and in dental institutions;
-   in clinics of schools, of kindergartens and of nursing homes;
and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients.
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.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".

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This European Standard specifies the European Standards to which products have to conform in order to support the claims for microbicidal activity which are referred to in this European Standard.
This European Standard also specifies terms and definitions which are used in European Standards.
It is applicable to products for which activity is claimed against the following microorganisms: vegetative bacteria (including mycobacteria and Legionella), bacterial spores, yeasts, fungal spores and viruses (including bacteriophages).
It is intended to:
a)   enable manufacturers of products to select the appropriate standards to be used in order to provide data which support their claims for a specific product;
b)   enable users of the product to assess the information provided by the manufacturer in relation to the use for which they intend to use the product;
c)   assist regulatory authorities in assessing claims made by the manufacturer or by the person responsible for placing the product on the market.
It is applicable to products to be used in the area of human medicine, the veterinary area and in food, industrial, domestic and institutional areas.
In the area of human medicine, it is applicable to chemical disinfectants and antiseptics to be used in areas and situations where disinfection or antisepsis is medically indicated. Such indications occur in patient care
-   in hospitals, in community medical facilities and dental institutions,
-   in clinics of schools, of kindergartens and of nursing homes,
-   and may also occur in the workplace and in the home. It may also include services such as in laundries and kitchens supplying products directly for the patient.
In the veterinary area it is applicable to chemical disinfectants and antiseptics to be used in the areas of breeding, husbandry, veterinary care facilities, production, transport and disposal of animals. It is not applicable to chemical disinfectants used in the food chain following death and entry to the processing industry.
In food, industrial, domestic and institutional areas it is applicable to chemical disinfectants and antiseptics to be used in processing, distribution and retailing of food of animal or vegetable origin. It is also applicable to products for all public areas where disinfection is not medically indicated (homes, catering, schools, nurseries, transports, hotels, offices etc.) and products used in packaging, biotechnology, pharmaceutical, cosmetic etc. industries.
This European Standard is also applicable to active substances and products under development for which no area of application has yet been specified.
This European Standard does not refer to methods for testing the toxicological and ecotoxicological properties of products or active substances.

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This document defines how to exclude or confirm that an excipient in a biocidal product is an active substance within the frame of the European Biocidal Product Regulation and other regulations.

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This document specifies a test method and the minimum requirements for virucidal activity of chemical disinfectant 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 document applies to products that are used in the medical area for disinfecting instruments by immersion.
This document applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
-   in hospitals, in community medical facilities and in dental institutions;
-   in clinics of schools, of kindergartens and of nursing homes;
-   and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients.
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.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".

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This document specifies a test method (phase 2/step 1) and the minimum requirements for sporicidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation in hard water and that are used in food, industrial, domestic and institutional areas, excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues except those for hand hygiene in the above considered areas.
This European Standard applies at least to the following:
a)   processing, distribution and retailing of:
1)   food of animal origin:
-   milk and milk products;
-   meat and meat products;
-   fish, seafood, and related products;
-   eggs and egg products;
-   animal feeds;
-   etc.;
2)   food of vegetable origin:
-   beverages;
-   fruits, vegetables and derivatives (including sugar, distillery, etc.);
-   flour, milling and baking;
-   animal feeds;
-   etc.;
b)   institutional and domestic areas:
-   catering establishments;
-   public areas;
-   public transports;
-   schools;
-   nurseries;
-   shops;
-   sports rooms;
-   waste containers (bins, etc.);
-   hotels;
-   dwellings;
-   clinically non sensitive areas of hospitals;
-   offices;
-   etc.;
c)   other industrial areas:
-   packaging material;
-   biotechnology (yeast, proteins, enzymes, etc.);
-   pharmaceutical;
-   cosmetics and toiletries;
-   textiles;
-   space industry, computer industry;
-   etc.
Using this European Standard, it is not possible to determine the sporicidal activity of undiluted product as some dilution is always produced by adding the inoculum and interfering substance. Products can only be tested at a concentration of 80 % or less.
NOTE   The method described is intended to determine the activity of commercial formulations or active substances on spores in the conditions in which they are used.

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This European Standard specifies a test method simulating practical conditions for establishing whether a product for surgical handrub and handwash reduces the release of resident and eventually present transient microbial flora on hands when used for the treatment of clean hands of volunteers.
This European Standard applies to products for surgical handrub or handwash for use in areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
-   in hospitals, in community medical facilities and in dental institutions;
-   in clinics of schools, of kindergartens and of nursing homes.
and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patient.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
NOTE   This method corresponds to a phase 2, step 2 test.

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This European Standard specifies a test method simulating practical conditions for establishing whether a product for surgical handrub and handwash reduces the release of resident and eventually present transient microbial flora on hands when used for the treatment of clean hands of volunteers.
This European Standard applies to products for surgical handrub or handwash for use in areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
-   in hospitals, in community medical facilities and in dental institutions;
-   in clinics of schools, of kindergartens and of nursing homes.
and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patient.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
NOTE   This method corresponds to a phase 2, step 2 test.

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ISO 11138-1:2017 specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.
ISO 11138-1:2017 specifies basic and common requirements that are applicable to all parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 11138. If no specific subsequent part is provided, this document applies.
NOTE National or regional regulations can apply.
ISO 11138-1:2017 does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems.

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ISO 11138-2:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.
NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135 and ISO 14937.
NOTE 2 National or regional regulations can provide requirements for work place safety.

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ISO 11138-3:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent.
NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by the ISO 17665 series.
NOTE 2 National or regional regulations can provide requirements for work place safety.

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2016-12-13: Decision 458 on de-harmonization of EN ISO 11138 series taken on 2016-12-09.

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ISO 11138-5:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent.
NOTE 1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937.
NOTE 2 Requirements for work place safety can be provided by national or regional regulations.

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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).

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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 (97 % with a modified method for special cases) 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 medical area in the fields of hygienic handrub, hygienic handwash, surgical handrub, surgical handwash, instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding or other means.
This European Standard applies to areas and situations where disinfection or antisepsis is medically indicated. Such indications occur in patient care, for example:
-   in hospitals, in community medical facilities and in dental institutions;
-   in clinics of schools, of kindergartens and of nursing homes;
and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients.
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.
NOTE 3   This method cannot be used to evaluate the activity of products against Legionella in watersystems and against mycobacteria.
EN 14885 specifies in detail the relationship of the various tests to one another and to 'use recommendations'.

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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 (97 % with a modified method for special cases) 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 medical area in the fields of hygienic handrub, hygienic handwash, surgical handrub, surgical handwash, instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding or other means.
This European Standard applies to areas and situations where disinfection or antisepsis is medically indicated. Such indications occur in patient care, for example:
-   in hospitals, in community medical facilities and in dental institutions;
-   in clinics of schools, of kindergartens and of nursing homes;
and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients.
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.
NOTE 3   This method cannot be used to evaluate the activity of products against Legionella in watersystems and against mycobacteria.
EN 14885 specifies in detail the relationship of the various tests to one another and to 'use recommendations'.

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This European Standard specifies a test method and the minimum requirements for the microbicidal activity of a defined disinfection process for the treatment of contaminated linen. This procedure is carried out by using a washing machine as defined in Chapter 5.3.2.17 and refers to the disinfection step without prewash.
This European Standard applies to areas and situations where disinfection is indicated. Such indications occur in patient care, for example:
-   in hospitals, in community medical facilities and in dental institutions;
-   in schools, kindergartens and nursing homes;
- institutions where patients are accommodated, which could suffer from transmissible diseases;
- other applications where hygienic treatment of linen is necessary (e.g. food processing, hotels, workwear e. g. from the pharmaceutical industry, laboratories, foodstuffs area or similar institutions).
The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
NOTE This method corresponds to a phase 2 step 2 test (Annex F).

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This European Standard specifies a test method and the minimum requirements for the microbicidal activity of a defined disinfection process for the treatment of contaminated linen. This procedure is carried out by using a washing machine as defined in Chapter 5.3.2.17 and refers to the disinfection step without prewash.
This European Standard applies to areas and situations where disinfection is indicated. Such indications occur in patient care, for example:
-   in hospitals, in community medical facilities and in dental institutions;
-   in schools, kindergartens and nursing homes;
- institutions where patients are accommodated, which could suffer from transmissible diseases;
- other applications where hygienic treatment of linen is necessary (e.g. food processing, hotels, workwear e. g. from the pharmaceutical industry, laboratories, foodstuffs area or similar institutions).
The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
NOTE This method corresponds to a phase 2 step 2 test (Annex F).

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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).

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This European Standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant 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 medical area for disinfecting non-porous surfaces by wiping - regardless if they are covered by the EEC/93/42 Directive on Medical Devices or not. This European Standard applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:  in hospitals, in community medical facilities and in dental institutions; in clinics of schools, of kindergartens and of nursing homes; and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients. NOTE This method corresponds to a phase 2, step 2. test. EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".

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This European Standard specifies a test method and the minimum requirements for bactericidal and yeasticidal activity of chemical disinfectant 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 medical area for disinfecting non-porous surfaces including surfaces of medical devices by wiping – regardless if they are covered by the 93/42/EEC Directive on Medical Devices or not.
This European Standard includes ‘ready-to-use wipes‘ which are impregnated with a microbicidal solution.
This European Standard applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
-   in hospitals, in community medical facilities and in dental institutions;
-   in clinics of schools, of kindergartens and of nursing homes;
and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients.
NOTE   This method corresponds to a phase 2, step 2. test.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.

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ISO 11140-1:2014 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the process parameter(s) specified for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.

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ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

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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 (97 % with a modified method for special cases) 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 medical area in the fields of hygienic handrub, hygienic handwash, surgical handrub, surgical handwash, instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding or other means. This European Standard applies to areas and situations where disinfection or antisepsis is medically indicated. Such indications occur in patient care, for example: - in hospitals, in community medical facilities and in dental institutions; - in clinics of schools, of kindergartens and of nursing homes; and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients.

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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 (97 % with a modified method for special cases) 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 medical area in the fields of hygienic handrub, hygienic handwash, surgical handrub, surgical handwash, instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding or other means.
This European Standard applies to areas and situations where disinfection or antisepsis is medically indicated. Such indications occur in patient care, for example:
-   in hospitals, in community medical facilities and in dental institutions;
-   in clinics of schools, of kindergartens and of nursing homes;
and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients.
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.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".

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This European Standard specifies a test method simulating practical conditions for establishing whether a product for hygienic handwash reduces the release of transient microbial flora on hands when used to wash the artificially contaminated hands of volunteers. NOTE 1 Attention is drawn to the fact that tests on human volunteers are the subject of legal provisions in certain European countries/regions. This European Standard applies to products for hygienic handwash for use in areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example: - in hospitals, in community medical facilities and in dental institutions; - in clinics of schools, of kindergardens and of nursing homes. and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patient. EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations". NOTE 2 This method corresponds to a phase 2, step 2 test.

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This European Standard specifies a test method simulating practical conditions for establishing whether a product for hygienic handrub reduces the release of transient microbial flora on hands when rubbed onto the artificially contaminated hands of volunteers. NOTE 1 Attention is drawn to the fact that tests on human volunteers are the subject of legal provisions in certain European countries/regions. This European Standard applies to products for hygienic handrub for use in areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
- in hospitals, in community medical facilities and in dental institutions,
- in clinics of schools, of kindergartens and of nursing homes;
and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patient. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”. NOTE 2 This method corresponds to a phase 2, step 2 test.

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This European Standard specifies a test method simulating practical conditions for establishing whether a product for hygienic handrub reduces the release of transient microbial flora on hands when rubbed onto the artificially contaminated hands of volunteers.
NOTE 1   Attention is drawn to the fact that tests on human volunteers are the subject of legal provisions in certain European countries/regions.
This European Standard applies to products for hygienic handrub for use in areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
- in hospitals, in community medical facilities and in dental institutions,
- in clinics of schools, of kindergartens and of nursing homes;
and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patient.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
NOTE 2   This method corresponds to a phase 2, step 2 test.

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This European Standard specifies a test method simulating practical conditions for establishing whether a product for hygienic handwash reduces the release of transient microbial flora on hands when used to wash the artificially contaminated hands of volunteers.
NOTE 1   Attention is drawn to the fact that tests on human volunteers are the subject of legal provisions in certain European countries/regions.
This European Standard applies to products for hygienic handwash for use in areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
- in hospitals, in community medical facilities and in dental institutions,
- in clinics of schools, of kindergartens and of nursing homes;
and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patient.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
NOTE 2   This method corresponds to a phase 2, step 2 test.

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This European Standard specifies the requirements and the test methods of the apertures for the delivery of letter post items when fitted in accordance with the manufacturer's instructions.
It takes into account security, impregnability, safety and performance for the recipient, and ergonomics and efficiency for delivery personnel. It allows the daily delivery in good condition of a great majority of letter post items.

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This European Standard specifies methods for keeping test organisms used and defined in European Standards for the determination of bactericidal (incl. Legionella pneumophila), mycobactericidal, sporicidal, fungicidal and virucidal (incl. bacteriophages) activity of chemical disinfectants and antiseptics drawn up by CEN/TC 216. These methods for keeping test organisms can only be carried out in connection with at least one of those standards where a reference to this European Standard is established.
NOTE 1   Annex A (informative) contains a non-exhaustive list of test organisms for which this standard can be applied.
NOTE 2   European Standards (EN and prEN) where this European Standard is referenced are listed in the Bibliography.
NOTE 3   A specific part on the preservation of bacterial spores may be added once the results of the ongoing ring trials are available.

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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.

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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.

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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.

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Amandma A1:2010 je dodatek k standardu SIST EN ISO 14729:2002
This International Standard specifies two test methods for evaluating the antimicrobial activity of products to be marketed for contact lens disinfection by chemical means and for products that are part of a contact lens care regimen. This International Standard is not applicable to the hygienic management of trial lenses.

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ISO 11140-3:2007 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1.
Indicators complying with ISO 11140-3:2007 are intended for use in combination with the standard test pack as described in EN 285. ISO 11140-3:2007 does not consider the performance of the standard test pack, but does specify the performance of the indicators.

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