71.100.35 - Chemicals for industrial and domestic disinfection purposes
ICS 71.100.35 Details
Chemicals for industrial and domestic disinfection purposes
Desinfektionsmittel fur den hauslichen und industriellen Bereich
Desinfectants a usage industriel et domestique
Kemikalije za dezinfekcijo v industriji in doma
General Information
Frequently Asked Questions
ICS 71.100.35 is a classification code in the International Classification for Standards (ICS) system. It covers "Chemicals for industrial and domestic disinfection purposes". The ICS is a hierarchical classification system used to organize international, regional, and national standards, facilitating the search and identification of standards across different fields.
There are 179 standards classified under ICS 71.100.35 (Chemicals for industrial and domestic disinfection purposes). These standards are published by international and regional standardization bodies including ISO, IEC, CEN, CENELEC, and ETSI.
The International Classification for Standards (ICS) is a hierarchical classification system maintained by ISO to organize standards and related documents. It uses a three-level structure with field (2 digits), group (3 digits), and sub-group (2 digits) codes. The ICS helps users find standards by subject area and enables statistical analysis of standards development activities.
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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 is applicable 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".
NOTE This method corresponds to a phase 2 step 1 test.
- Standard35 pagesEnglish languagee-Library read for1 day
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.
- Standard64 pagesEnglish languagee-Library read for1 day
This document specifies a test method and the minimum requirements for the microbicidal activity of a specified disinfection process for the treatment of contaminated textile. This procedure is carried out by using a washing machine as specified in 5.3.2.18 and refers to the disinfection step without prewash. This procedure is not limited to certain types of textile. The suppliers' instructions are expected to be sufficient if they content the process parameters identified in the test (e.g. dosing disinfectant in whatever washing phase e.g. main wash, rinsing, disinfecting at 40 °C).
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 could occur in the workplace and in the home.
It could also include services such as laundries and kitchens supplying products directly for the patients.
The method described is intended to determine the activity of a product or product combination under the conditions in which they are used. This is a phase 2, step 2 laboratory test that simulates the conditions of application of the product.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.
- Standard49 pagesEnglish languagee-Library read for1 day
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.
- Standard64 pagesEnglish languagee-Library read for1 day
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 food, industrial, domestic and institutional area for disinfecting non-porous surfaces without mechanical action, excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues.
This document 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) industries other than food:
- packaging material;
- biotechnology (yeast, proteins, enzymes, etc.);
- pharmaceutical;
- cosmetics and toiletries;
- textiles;
- space industry, computer industry;
- etc.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.
- Standard43 pagesEnglish languagee-Library read for1 day
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 is applicable 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".
NOTE This method corresponds to a phase 2 step 1 test.
- Standard35 pagesEnglish languagee-Library read for1 day
This document 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 document is applicable to products that are used in the food, industrial, domestic and institutional area for surface disinfection by wiping, spraying, flooding or otherwise, and for disinfection of textile and equipment, excluding areas and situations where disinfection is medically indicated.
This document does not apply to hand disinfection and hygienic hand washing products, as this is medically indicated in most cases. For hand disinfection and hygienic hand washing products, refer to EN 14476.
This document does not apply to products used on living tissues and excluding products which fall under the scope of EN 17272.
This document is applicable at least to the following:
a) processing, distribution and retailing of:
- food of animal origin:
- milk and milk products;
- meat and meat products;
- fish, seafood, and related products;
- eggs and egg products;
- animal feeds;
- etc.;
- 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) industries other than food:
- packaging material;
- biotechnology (yeast, proteins, enzymes, etc.);
- pharmaceutical;
- cosmetics and toiletries;
- textiles;
- space industry, computer industry;
- etc.
NOTE EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
- Standard40 pagesEnglish languagee-Library read for1 day
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 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 veterinary area for disinfecting 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 in the conditions in which they are used.
NOTE 2 This method corresponds to a Phase 2 Step 2 test.
This method excludes the evaluation of the activity of products against yeasts, fungal spores, mycobacteria and bacterial spores.
- Standard39 pagesEnglish languagee-Library read for1 day
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 food, industrial, domestic and institutional area for disinfecting non-porous surfaces without mechanical action, excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues.
This document 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) industries other than food:
- packaging material;
- biotechnology (yeast, proteins, enzymes, etc.);
- pharmaceutical;
- cosmetics and toiletries;
- textiles;
- space industry, computer industry;
- etc.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.
- Standard43 pagesEnglish languagee-Library read for1 day
This document 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 document is applicable to products that are used in the food, industrial, domestic and institutional area for surface disinfection by wiping, spraying, flooding or otherwise, and for disinfection of textile and equipment, excluding areas and situations where disinfection is medically indicated.
This document does not apply to hand disinfection and hygienic hand washing products, as this is medically indicated in most cases. For hand disinfection and hygienic hand washing products, refer to EN 14476.
This document does not apply to products used on living tissues and excluding products which fall under the scope of EN 17272.
This document is applicable at least to the following:
a) processing, distribution and retailing of:
- food of animal origin:
- milk and milk products;
- meat and meat products;
- fish, seafood, and related products;
- eggs and egg products;
- animal feeds;
- etc.;
- 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) industries other than food:
- packaging material;
- biotechnology (yeast, proteins, enzymes, etc.);
- pharmaceutical;
- cosmetics and toiletries;
- textiles;
- space industry, computer industry;
- etc.
NOTE EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
- Standard40 pagesEnglish languagee-Library read for1 day
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 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 veterinary area for disinfecting 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 in the conditions in which they are used.
NOTE 2 This method corresponds to a Phase 2 Step 2 test.
This method excludes the evaluation of the activity of products against yeasts, fungal spores, mycobacteria and bacterial spores.
- Standard39 pagesEnglish languagee-Library read for1 day
This document 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 document applies to products that are used 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 into processing industry. This document also applies to products used for teat disinfection.
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.
- Standard48 pagesEnglish languagee-Library read for1 day
This document 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 document applies to products that are used 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 into processing industry. This document also applies to products used for teat disinfection.
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.
- Standard48 pagesEnglish languagee-Library read for1 day
This document provides additional information and recommendations on the preparation of spores and a
test method to determine / exclude sporistatical activity respectively differentiate between sporistatical
and sporicidal activity of a product.
- Technical report13 pagesEnglish languagee-Library read for1 day
This document provides additional information and recommendations on the preparation of spores and a
test method to determine / exclude sporistatical activity respectively differentiate between sporistatical
and sporicidal activity of a product.
- Technical report13 pagesEnglish languagee-Library read for1 day
This document specifies a test method (phase 2/step 2) and the minimum requirements for bactericidal and yeasticidal and/or fungicidal 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.
This document applies to products that are used for disinfecting non-porous surfaces without mechanical action.
This document is applicable 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 distilleries and sugar refineries);
iii) flour, milling and baking;
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 containers (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.
This document does not apply when the product is applied via an automatic airborne disinfection method; in such cases, see EN 17272.
Using this document, it is possible to determine the bactericidal and/or yeasticidal and/or fungicidal 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.
- Standard41 pagesEnglish languagee-Library read for1 day
This document specifies a test method (phase 2/step 2) and the minimum requirements for bactericidal and yeasticidal and/or fungicidal 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.
This document applies to products that are used for disinfecting non-porous surfaces without mechanical action.
This document is applicable 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 distilleries and sugar refineries);
iii) flour, milling and baking;
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 containers (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.
This document does not apply when the product is applied via an automatic airborne disinfection method; in such cases, see EN 17272.
Using this document, it is possible to determine the bactericidal and/or yeasticidal and/or fungicidal 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.
- Standard41 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
5.1 This practice is to be used for the removal of virucidal agents from test product-virus mixtures, or from test product-neutralizer-virus mixtures, at or after the contact period and before the inoculation of these mixtures into host systems for assay of viral infectivity.
5.2 The purpose of the practice is to reduce the concentration of the cytotoxic properties of the test product and neutralizers in order to permit the evaluation of viral infectivity at dilutions that would otherwise be toxic to the host cells.
5.3 The practice is applicable to the testing of liquid, pre-saturated towelettes, and pressurized disinfectant products, as well as handwash/rub products.
Note 3: When testing products, the ability of the solution to pass through the column must be verified prior to testing. Certain products with high viscosities are unable to pass through columns. If the product is determined to be too viscous, alternative neutralization methods should be employed.
5.4 This practice is compatible with organic soil loads, hard water, disinfectants containing organic solvents, and chemical neutralizers.
SCOPE
1.1 This practice is intended to be used to reduce the cytotoxic level of the virus-test product mixture prior to assaying for viral infectivity. It is used in conjunction with evaluations of the virucidal efficacy of disinfectant solutions, wipes, trigger sprays, or pressurized disinfectant spray products intended for use on inanimate, nonporous environmental surfaces. This practice may also be used in the evaluation of hygienic handwashes/handrubs, or for other special applications. The practice may be employed with all viruses and host systems.
Note 1: Gel filtration columns may impact virus titer and their use should be taken into consideration when selected for use.
1.2 This practice should be performed only by persons trained in virology techniques.
1.3 This practice utilizes gel filtration technology. The effectiveness of the practice is dependent on the ratio of gel bed volume to sample size and uniformity in the preparation of columns as well as the conditions of centrifugation. The effectiveness of this practice is maximized by investigator practice and experience with gel filtration techniques.
1.4 This practice will aid in the reduction, but not necessarily elimination, of test product toxicity while preserving the titer of the input virus.
1.5 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Standard3 pagesEnglish languagesale 15% off
- Standard3 pagesEnglish languagesale 15% off
- Corrigendum3 pagesEnglish languagee-Library read for1 day
This document specifies a test method and the minimum performance requirements for the microbicidal efficacy of a chemical product intended for use in a wash process in a domestic environment, in a domestic wash equipment at low temperatures (≤40 °C). This procedure does not apply to certain types of laundry disinfection technologies which require specific devices (i.e. active substances generated in situ using specific devices). This method is not limited to certain types of textiles, types of products or steps in the washing cycle.
According to a phase 2, step 2 test definition, this document establishes the efficacy in laboratory test simulating practical use conditions of a chemical product.
This document cannot be applied when the disinfection is medical indicated (medical area) or in hygiene-sensitive areas where professional reprocessing of laundry is required (i.e. food, healthcare, medical and cleanroom sectors, PPE, and workwear). In those cases, EN 16616 and EN 14065 will apply.
NOTE This method corresponds to a phase 2, step 2 test (see EN 14885).
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.
- Standard48 pagesEnglish languagee-Library read for1 day
- Corrigendum3 pagesEnglish languagee-Library read for1 day
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.
- Standard27 pagesEnglish languagee-Library read for1 day
This document 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 document.
This document 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 (Working Group 1, i.e. WG 1), 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, dental institutions and medical laboratories for analyses and research,
— 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 (WG 2) 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 and veterinary laboratories for analyses and research. 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 (WG 3) 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, laboratories (except laboratories for veterinary and medical analyses and research), pharmaceutical, cosmetic etc. industries.
This document is also applicable to active substances and products under development for which no area of application has yet been specified.
This document will be periodically updated to reflect the current published versions of each standard developed in CEN/TC 216. Independent of this update newly published standards are to be used, even if they are not yet mentioned in EN 14885.
This document does not refer to methods for testing the toxicological and ecotoxicological properties of products or active substances.
- Standard72 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
5.1 The effectiveness of antimicrobial agents incorporated into disinfectants, sanitizers, and antiseptics is measured by their ability to kill microorganisms within a specified contact time. Hence, accurate determination of antimicrobial effectiveness requires complete and immediate inactivation (neutralization) of the antimicrobial agent. Inefficient or incomplete neutralization will permit killing or inactivation of microorganisms to continue beyond the experimental exposure time, resulting in an overestimation of antimicrobial activity.
5.2 The neutralization methods commonly used in antimicrobial effectiveness evaluations are chemical inactivation, dilution, and filtration. All critical parameters of an antimicrobial effectiveness evaluation—for example, media, equipment, microorganism(s), and temperature of solutions—must be duplicated in the performance of selected neutralization procedure.
5.3 The neutralization evaluation must include at least three replications (five replications in Section 9) so that a statistical analysis of the microbial recovery data can be performed. The number of replicates used in the evaluation depends on the statistical significance required for the expected results, the variability encountered in the data, and the relative effectiveness of the neutralization procedure.
5.4 A limitation of these evaluation procedures is that they use microorganisms that have not been exposed to an antimicrobial agent. Under experimental conditions, cells exposed to neutralization procedures are likely to be damaged to different degrees by the antimicrobial agent. Sublethal injury may be a factor in recovery, and the effect of the neutralization procedure on recovery of injured organisms should be examined. This method is not intended to assess recovery of injured organisms.
Note 3: Ideally, all microorganisms used in the antimicrobial effectiveness evaluation should be tested in the neutralization assay. However, representative organism...
SCOPE
1.1 These test procedures are used to determine the effectiveness of methodologies procedures and materials intended for inactivating (neutralizing, quenching) the microbicidal properties of antimicrobial agents; to ensure that no components of the neutralizing procedures and materials, themselves, exert an inhibitory effect on microorganisms targeted for recovery; and to demonstrate that the antimicrobial chemistry tested is microbicidal.
1.2 Knowledge of microbiological and statistical techniques is required for these procedures.
Note 1: These methods are not suitable when testing the virucidal activity of microbicides (see Test Method E1482).
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
4.1 This test method shall be used to determine if a chemical intended for use as a non-food contact sanitizer or as a one-step cleaner-sanitizer provides percent reductions of the selected test organisms on treated carriers as compared to control.
SCOPE
1.1 This test method is used to evaluate the antimicrobial efficacy of sanitizers on precleaned, inanimate, hard, nonporous, non-food contact surfaces against Staphylococcus aureus, or Klebsiella pneumoniae or Klebsiella aerogenes, or a combination thereof. Appropriate modifications to the method may be required when testing organisms not specified herein. When utilizing test surfaces not described herein (see Test Method E2274) or when evaluating spray-based or towelette-based antimicrobial products, modifications may also be required.
1.2 This test method may also be used to evaluate the antimicrobial efficacy of one-step cleaner-sanitizer formulations recommended for use on lightly soiled, inanimate, nonporous, non-food contact surfaces.
1.3 It is the responsibility of the investigator to determine whether Good Laboratory Practices (GLP) are required and to follow them where appropriate (see section 40 CFR, 160 or as revised.)
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 This standard may involve hazardous materials, chemicals and microorganisms and should be performed only by persons who have had formal microbiological training. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
5.1 This practice may be used to determine if a pre-saturated or impregnated towelette demonstrates antimicrobial effectiveness as a disinfectant on hard surfaces. This practice provides survivor results in the form of a qualitative endpoint (growth positive versus growth negative). The results generated by following this practice do not provide for specific quantitative reductions.
SCOPE
1.1 This practice is designed to evaluate the antimicrobial activity of pre-saturated or impregnated towelettes when used as a hard surface disinfectant.
1.2 It is the responsibility of the investigator to determine whether Good Laboratory Practices (GLP’s) are required and to follow them when appropriate.
1.3 This practice should be performed only by those trained in microbiological techniques.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 Appropriate modifications to the practice may be required when testing organisms not specified herein.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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This document specifies a test method and the minimum performance requirements for the microbicidal efficacy of a chemical product intended for use in a wash process in a domestic environment, in a domestic wash equipment at low temperatures (≤40 °C). This procedure does not apply to certain types of laundry disinfection technologies which require specific devices (i.e. active substances generated in situ using specific devices). This method is not limited to certain types of textiles, types of products or steps in the washing cycle.
According to a phase 2, step 2 test definition, this document establishes the efficacy in laboratory test simulating practical use conditions of a chemical product.
This document cannot be applied when the disinfection is medical indicated (medical area) or in hygiene-sensitive areas where professional reprocessing of laundry is required (i.e. food, healthcare, medical and cleanroom sectors, PPE, and workwear). In those cases, EN 16616 and EN 14065 will apply.
NOTE This method corresponds to a phase 2, step 2 test (see EN 14885).
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 the European Standards to which products have to conform in order to support the claims for microbicidal activity which are referred to in this document.
This document 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 (Working Group 1, i.e. WG 1), 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, dental institutions and medical laboratories for analyses and research,
— 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 (WG 2) 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 and veterinary laboratories for analyses and research. 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 (WG 3) 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, laboratories (except laboratories for veterinary and medical analyses and research), pharmaceutical, cosmetic etc. industries.
This document is also applicable to active substances and products under development for which no area of application has yet been specified.
This document will be periodically updated to reflect the current published versions of each standard developed in CEN/TC 216. Independent of this update newly published standards are to be used, even if they are not yet mentioned in EN 14885.
This document does not refer to methods for testing the toxicological and ecotoxicological properties of products or active substances.
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SIGNIFICANCE AND USE
5.1 Hand hygiene is considered one of the most important measures for preventing the spread of infectious microorganisms. Hand rubs reduce the microbial load on the hands without the use of soap and water, and are thus an important tool in the practice of good hand hygiene. Alcohol-based hand rubs are recommended in healthcare settings for use on hands that are not visibly soiled. They are formulated to be applied full strength to dry hands, “rubbed in” until dry, and are not rinsed off.
5.2 This test method is designed specifically to evaluate hand rubs for efficacy in eliminating bacteria from experimentally-contaminated hands. It is designed as an alternative to Test Method E1174, which was intended primarily to evaluate antimicrobial handwashing agents that are lathered with the aid of water and then rinsed off. When using Test Method E1174 to evaluate hand rubs, inadequate drying of the hands after contamination dilutes the test material and can compromise activity, to result in an underestimation of effectiveness. Additionally, because hand rubs are not rinsed after product use, activity can be further degraded by build-up of soil from the contaminating broth and inactivated challenge bacteria on the hands.
5.2.1 In this method, application to the hands of a small volume of high-titer test bacteria suspension minimizes soil load such that the skin is completely dry prior to application of the test material. Further, by applying the bacterial suspension only prior to those test material application cycles followed by sampling, excessive buildup of killed bacteria on the hands is avoided, and the potential impact of non-volatile test product ingredients on bacteria-eliminating effectiveness after ten consecutive applications can be specifically assessed.
5.3 A reference control is evaluated for each subject prior to evaluation of the test material. Data from the reference control helps to control for inter-subject variability, inter-experimental variabi...
SCOPE
1.1 This test method is designed to determine the activity of healthcare personnel hand rubs, (also known as hand rubs, hygienic hand rubs, hand sanitizers, or hand antiseptics) against transient microbial skin flora on the hands after a single application and after repeated applications.
1.2 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (see 21 CFR Parts 50 and 56).
1.3 This test method should be performed by persons with training in microbiology, in facilities designed and equipped for work with potentially infectious agents at biosafety level 2.2,3
1.4 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. For more specific precautionary statements, see 8.2.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
5.1 The guide may be used to demonstrate the effectiveness of topical antimicrobial products using pigskin as a surrogate for human skin and the cup scrub technique for sampling.
5.2 The techniques described can be used to simulate Test Method E1174 and will use the pigskin substrate to overcome limitations posed by exposure of human subjects to potentially pathogenic microorganisms, while offering the benefit of applicability to a wide variety of hand-washing conditions that cannot be simulated in test tubes.
5.3 Use of the pigskin surrogate offers less expensive and higher throughput screening.
SCOPE
1.1 This guide is designed to demonstrate the effectiveness of hand hygiene topical antimicrobial products using pigskin as a surrogate model.
1.2 Knowledge of microbiological techniques is required for these procedures.
1.3 This standard guide can be used to evaluate topical antimicrobial handwash or handrub formulations.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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This document 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 document is established.
NOTE 1 Annex A (informative) contains a non-exhaustive list of test organisms for which this document can be applied.
NOTE 2 European Standards (EN) where this document is referenced are listed in the Bibliography.
NOTE 3 A specific description on the preservation of bacterial spores could be added once the results of the ongoing ring trials are available.
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This document 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 document is established.
NOTE 1 Annex A (informative) contains a non-exhaustive list of test organisms for which this document can be applied.
NOTE 2 European Standards (EN) where this document is referenced are listed in the Bibliography.
NOTE 3 A specific description on the preservation of bacterial spores could be added once the results of the ongoing ring trials are available.
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This document specifies a test method and the minimum requirements for bactericidal and yeasticidal and additionally fungicidal 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.
NOTE Dilutions are necessary as three concentrations in the active to non-active range are tested.
This document applies to products that are used in the medical area for disinfecting non-porous surfaces without mechanical action.
This document 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 can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patients.
EN 14885 specifies in detail the relationship of the various tests to one another and to use recommendations.
Using this document, it is possible to determine the activity of products like commercial formulations or active substances on bacteria and/or fungi in the conditions in which they are used and therefore it corresponds to a phase 2, step 2 test.
This method excludes the evaluation of the activity of products against mycobacteria and bacterial spores.
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SIGNIFICANCE AND USE
5.1 The Single Tube Method is designed to evaluate the efficacy of disinfectants against biofilm grown in the CDC biofilm reactor following the procedures outlined in Practice E3161. Biofilm grown in the CDC reactor is representative of biofilm that forms under high fluid shear on surfaces conducive to biofilm formation.
5.1.1 Vegetative biofilm bacteria are phenotypically different from suspended planktonic cells of the same genotype. Biofilm growth reactors are engineered to produce biofilm with specific characteristics (2). Altering either the engineered system or operating conditions will modify those characteristics as well as the physicochemical environment. The goal in biofilm research and testing is to choose the growth reactor and operating conditions that generate the most relevant biofilm for the particular study.
5.2 The test method was designed to determine the log10 reduction in bacteria after exposure to a disinfectant in a closed system.
5.3 The test method uses 50 mL conical tubes. The conical geometry allows for disinfectant exposure to biofilm on all surfaces of the coupon. For foaming disinfectants or for disinfectants requiring a larger volume of neutralizer, 250 mL conical tubes are used which preserve the required geometry and allow for greater neutralization capacity.
5.4 Each test includes three untreated control coupons (exposed to buffered dilution water) and five treated coupons (per disinfectant/concentration/contact time combination).
SCOPE
1.1 This test method specifies the operational parameters required to perform a quantitative liquid disinfectant efficacy test against bacterial biofilm.
1.2 The test method was optimized and validated for a Pseudomonas aeruginosa or Staphylococcus aureus biofilm grown in the CDC Biofilm Reactor (E3161). The method is suitable for evaluating additional bacteria grown using the procedures outlined in methods with comparable coupon dimensions such as Practice E3161, Test Method E2562, or Test Method E2196.
1.3 Disinfectant preparation and contact time are used in the assessment according to the manufacturer’s instructions for use.
1.4 The test method uses a closed system to treat biofilm. A coupon is placed in a single tube for the treatment, neutralization, and harvesting steps to prevent the loss of cells.
1.5 This test method describes a harvesting and analysis procedure which includes vortexing and sonicating treated and untreated control biofilm, and recovery of culturable cells using filtration to lower the limit of detection. Biofilm population density is recorded as log10 colony-forming units per coupon. Efficacy is reported as a log10 reduction of culturable cells.
1.6 Basic microbiology training is required to perform this assay.
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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This document specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant products intended to be used for treatment in aqueous systems against Legionella pneumophila that form a homogeneous, physically stable preparation when diluted with buffered ferrous hard water or hard water. Whenever Legionella pneumophila poses a risk to human health, this method is suitable for water used in cooling towers and water for general purposes, like spas, pools, showers and other uses. The method is not suitable for electro-chemical disinfection.
The document applies to products used as a single application shock treatment in order to kill Legionella pneumophila. It is not suitable for the evaluation of those products that are dosed continuously into water systems to control the growth of Legionella pneumophila.
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 does not take into account the fact that Legionella pneumophila is often found in cells of amoebae and/or biofilms and that thereby a product’s activity against the bacteria may be reduced.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendation".
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SIGNIFICANCE AND USE
5.1 Hand hygiene is considered one of the most important measures for preventing the spread of infectious microorganisms and is critical for reducing the incidence of food-borne disease. Food-handling settings are unique in that moderate to heavy soil load present on hands often can influence the ability of a product to remove or kill microorganisms (3, 4). Test methods are needed for assessing the efficacy of hand hygiene products under conditions representative of those encountered in a food-handling environment.
5.2 This test method is specifically designed to evaluate the effectiveness of food-handler products to kill and remove bacteria from experimentally-contaminated hands under conditions of moderate to heavy organic soil load. The inclusion of soils typical of food service setting makes this a methodology more appropriate than Test Method E1174, which was designed to evaluate healthcare personnel hand washes and does not include an option to include soil (4).
SCOPE
1.1 This test method is designed to determine the activity of food-handler handwashes against transient bacterial flora on the hands.
1.2 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (1)2.
1.3 This test method should be performed by persons with training in microbiology, in facilities designed and equipped for work with potentially infectious agents at biosafety level 2 (2).
1.4 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. For more specific precautionary statements see 8.1.1.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
5.1 This test method is designed to evaluate the virus-eliminating activity of hygienic handwash and handrub agents from experimentally-contaminated hands. Such formulations may be further assessed in a clinical trial for their effectiveness in the field. This test method incorporates whole-hand exposure and reflects actual use conditions such as friction during hand decontamination, and enables alternative product forms such as alcohol- or non-alcohol-based liquids, gels, and foams to be tested according to label directions. It is meant to extend, if required, the results of testing with Test Method E1838, which gives precise reductions in viral infectivity on a limited area of the hands. It may also serve as an alternative test method when product form is not amenable to testing by Test Method E1838.
5.2 This test method is not meant for use with surgical hand scrubs or preoperative skin preparations.
Note 2: Application of viruses on the entire surface of both hands entails a greater risk to the subjects than using fingerpads only. Therefore, greater care is needed to ensure that the hands of the participants are free from any apparent damage. Also, virus preparations must be thoroughly screened for, or documented to be free from, extraneous or adventitious pathogens before use in such tests.
SCOPE
1.1 This test method is designed to evaluate handwash or handrub agents for their ability to reduce or eliminate viable viruses from the skin of human hands.
Note 1: A knowledge of virological techniques is required for this test method.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 This standard may involve hazardous materials, operations and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. The user should consult a reference for laboratory safety recommendations. (3-5)
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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This document specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant products intended to be used for treatment in aqueous systems against Legionella pneumophila that form a homogeneous, physically stable preparation when diluted with buffered ferrous hard water or hard water. Whenever Legionella pneumophila poses a risk to human health, this method is suitable for water used in cooling towers and water for general purposes, like spas, pools, showers and other uses. The method is not suitable for electro-chemical disinfection.
The document applies to products used as a single application shock treatment in order to kill Legionella pneumophila. It is not suitable for the evaluation of those products that are dosed continuously into water systems to control the growth of Legionella pneumophila.
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 does not take into account the fact that Legionella pneumophila is often found in cells of amoebae and/or biofilms and that thereby a product’s activity against the bacteria may be reduced.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendation".
- Standard38 pagesEnglish languagee-Library read for1 day
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 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, flooding or other means and teat disinfection in the veterinary area - e.g. in the breeding, husbandry, production, veterinary care facilities, transport and disposal of all animals except when in the food chain following death and entry into processing industry. This document also applies to products used for teat disinfection in these veterinary areas.
This method is not applicable to evaluate the activity of hand hygiene products. For these products reference is made to EN 14885, which 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 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. 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 document applies to products 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. The following areas are at least included:
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.
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 document 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 document applies to products 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. The following areas are at least included:
a) processing, distribution and retailing of:
1) food of animal origin: 2) food of vegetable origin:
- milk and milk products; - beverages;
- meat and meat products; - fruits, vegetables and derivatives (including sugar, distillery ...);
- fish, seafood, and related products; - flour, milling and baking;
- eggs and egg products; - animal feeds;
- animal feeds; - etc.
- etc.
b) institutional and domestic areas:
- catering establishments;
- public areas;
- public transports;
- schools;
- nurseries;
- shops;
- sports rooms;
- waste containers (bins ...);
- hotels;
- dwellings;
- clinically non-sensitive areas of hospitals;
- offices;
- etc.
c) other industrial areas:
- packaging material;
- biotechnology (yeast, proteins, enzymes, ...);
- pharmaceutical;
- cosmetics and toiletries;
- textiles;
- space industry, computer industry;
- etc.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
- Standard47 pagesEnglish languagee-Library read for1 day
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, !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 This method cannot be used to evaluate the activity of products against mycobacteria or bacterial spores.
- Standard37 pagesEnglish languagee-Library read for1 day
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, !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 This method cannot be used to evaluate the activity of products against mycobacteria or bacterial spores.
- Standard37 pagesEnglish languagee-Library read for1 day
This document 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 document applies to products 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. The following areas are at least included:
a) processing, distribution and retailing of:
1) food of animal origin: 2) food of vegetable origin:
- milk and milk products; - beverages;
- meat and meat products; - fruits, vegetables and derivatives (including sugar, distillery ...);
- fish, seafood, and related products; - flour, milling and baking;
- eggs and egg products; - animal feeds;
- animal feeds; - etc.
- etc.
b) institutional and domestic areas:
- catering establishments;
- public areas;
- public transports;
- schools;
- nurseries;
- shops;
- sports rooms;
- waste containers (bins ...);
- hotels;
- dwellings;
- clinically non-sensitive areas of hospitals;
- offices;
- etc.
c) other industrial areas:
- packaging material;
- biotechnology (yeast, proteins, enzymes, ...);
- pharmaceutical;
- cosmetics and toiletries;
- textiles;
- space industry, computer industry;
- etc.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
- Standard47 pagesEnglish languagee-Library read for1 day
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 document applies to products 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. The following areas are at least included:
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.
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.
- Standard41 pagesEnglish languagee-Library read for1 day
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.
- Standard41 pagesEnglish languagee-Library read for1 day
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".
- Standard59 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
5.1 The practice can be used to evaluate coupon materials of any composition, insofar as the coupon can be small enough to fit inside filter units mentioned in 4.1.
5.2 This practice defines procedures that are quantitative, scalable, rapid, sensitive, and safe, while minimizing labor and addressing statistical confidence (1, 2).
5.2.1 Quantitative—The total number of spores per coupon is determined by dilution-plating, and all spores remaining on the coupon are assayed for activity in the extraction tube to provide confidence that all the spores were accounted for.
5.2.2 Statistical Confidence—The use of five independent preparations of spore inocula for a statistical n of 5.
5.2.3 Sensitivity—Allows for complete detection of all culturable spores inoculated on a coupon, including the spores that remain attached to the coupon.
5.2.3.1 The limit of detection is dependent on the culturability of fully matured spores to germinate, outgrow and divide in the presence of the extraction medium (1% tryptic soy broth, 100 mM L-Alanine, 1 mM inosine, 0.05% Tween 80) and/or on tryptic soy agar.
5.2.3.2 Results presented in Refs (1, 3) (and currently unpublished results) indicate that these media, combined with the test temperatures and conditions described herein will generate results with a high level of practical confidence for detecting culturable Bacillus spores.
5.2.4 Safety—Inoculated coupons are contained within filter units.
5.2.5 Simplicity of Testing—Tests and extractions are performed in the same filter unit to minimize coupon handling steps.
5.2.6 Scalable and Rapid—A maximum of 36 samples can be processed in 1 h by two technicians; a total of 300 samples have been processed by six technicians in 5 h (1, 2).
5.2.7 Wide application for numerous Bacillus species and strains. The method has also been modified and used for vegetative bacteria and viruses as well (1, 2).
SCOPE
1.1 This practice is used to quantify the efficacy of liquid or solid decontaminants on Bacillus spores dried on the surface of coupons made from porous and non-porous materials. This practice can distinguish between bactericidal and bacteriostatic chemicals within decontamination mixtures. This is important because many decontaminants contain both reactive compounds and high concentrations of bacteriostatic surfactants. All test samples are directly compared to pre-neutralized controls, un-inoculated negative growth controls, and solution controls on the same day as the test in order to increase practical confidence in the inactivation data.
1.2 This procedure should be performed only by those trained in microbiological techniques, are familiar with antimicrobial (sporicidal) agents and the application instructions of the antimicrobial products.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Standard11 pagesEnglish languagesale 15% off
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.
- Standard41 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
5.1 The practice can be used to evaluate coupon materials of any composition, insofar as the coupon can be prepared small enough to fit inside a 50-ml conical tube.
5.2 This practice defines procedures that are quantitative, scalable, rapid, sensitive, safe, reduces consumables, minimizes labor and addresses statistical confidence (1, 2, 4).
5.2.1 Quantitative—The total number of spores per coupon is determined by dilution-plating, and all spores remaining on the coupon are assayed for activity in the extraction tube to provide confidence that 100 % of spores were assayed.
5.2.2 Statistical Confidence—The use of five independent preparations of spore inoculum for a statistical N of 5.
5.2.3 Sensitivity—Allows for complete detection of all viable spores inoculated on a coupon, including the spores that remain attached to the coupon.
5.2.4 Safety—Inoculated coupons are contained within 0.2 µm filter-capped 50-ml conical tubes. The 0.2 µm filter allows vaporous decontaminants to pass through while preventing escape of spores, thereby providing an important level of containment when working with pathogenic strains.
5.2.5 Simplicity of Testing—Tests and extractions are performed in the same 50-ml conical tube to minimize handling steps.
5.2.6 Scalable and Rapid—A maximum of 36 samples can be processed in 1 h by two technicians; a total of 300 samples have been processed by six technicians in 5 h (1-3).
5.2.7 Wide application for numerous Bacillus species and strains.
Note 1: This practice differs from similar quantitative methods (E2111, E2197 and E2414) in the size and variety of coupon materials available for testing, in the practical confidence of the statistics, the application of the decontaminant, scalability and sensitivity.
SCOPE
1.1 This practice is used to quantify the efficacy of vaporous decontaminants on Bacillus spores dried on the surface of coupons made from porous and non-porous materials and contained within 0.2µm filter-capped tubes.
1.2 This practice should be performed only by those trained in microbiological techniques, are familiar with antimicrobial (sporicidal) agents and with the end use of such products.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Standard9 pagesEnglish languagesale 15% off