11.080 - Sterilization and disinfection
ICS 11.080 Details
Sterilization and disinfection
Sterilisation. Desinfektion
Sterilisation et desinfection
Sterilizacija in dezinfekcija
General Information
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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 languagesale 10% offe-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. Ready-to-use-products can only be tested at a concentration up to 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 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 document is applicable 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 can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patient.
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”.
- Standard51 pagesEnglish languagesale 10% offe-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 languagesale 10% offe-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 languagesale 10% offe-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 languagesale 10% offe-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 languagesale 10% offe-Library read for1 day
TThis 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. Ready-to-use-products can only be tested at a concentration up to 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 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 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 can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patient.
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".
- Standard51 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids.
This document applies to automatically controlled small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer.
This document applies to small steam sterilizers used primarily for the sterilization of medical devices with a chamber volume of less than 60 l and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm).
The requirements concerning the quality management and risk management are addressed by other standards (e.g. EN ISO 13485, EN ISO 14971).
This document does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products.
This document does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases).
This document does not specify requirements for the validation and routine control of sterilization by moist heat.
NOTE Requirements for the validation and routine control of sterilization by moist heat are given in EN ISO 17665.
This document does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).
- Standard121 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids.
This document applies to automatically controlled small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer.
This document applies to small steam sterilizers used primarily for the sterilization of medical devices with a chamber volume of less than 60 l and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm).
The requirements concerning the quality management and risk management are addressed by other standards (e.g. EN ISO 13485, EN ISO 14971).
This document does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products.
This document does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases).
This document does not specify requirements for the validation and routine control of sterilization by moist heat.
NOTE Requirements for the validation and routine control of sterilization by moist heat are given in EN ISO 17665.
This document does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).
- Standard121 pagesEnglish languagesale 10% offe-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 languagesale 10% offe-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 languagesale 10% offe-Library read for1 day
This document specifies the requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as:
a) bed frames;
b) bedside tables;
c) transport carts;
d) containers;
e) surgical tables;
f) sterilization containers;
g) surgical clogs;
h) wheelchairs;
i) aids for persons with disabilities.
This document also specifies the performance requirements for the cleaning and disinfection of the WD and its components and accessories.
Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO 15883-4, and ISO 15883-6 do not fall within the scope of this document.
In addition, this document specifies the methods for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control, and monitoring, as well as requalifications to be carried out periodically and after essential repairs.
NOTE 1 WD covered by this document can also be used for cleaning and chemical disinfection of other thermolabile and reusable devices as recommended in the instructions for use (IFU) for those devices.
NOTE 2 The performance requirements specified in this document cannot ensure the inactivation or removal of the causative agent(s) (prion proteins) of transmissible spongiform encephalopathies.
- Standard44 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies test methods and values for single-use paper bags manufactured from paper specified in EN 868-3, used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
- Standard20 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies test methods and values for sealable adhesive coated paper manufactured from paper complying with EN 868-6, used as single-use sterile barrier systems and/or single-use packaging systems for terminally sterilized medical devices by the means of low temperature sterilization processes.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 [2], this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
- Standard31 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies test methods and values for paper used in the manufacture of single-use preformed sterile barrier systems and/or packaging systems for terminally sterilized medical devices by means of low temperature sterilization processes.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 [2], this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
- Standard23 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies test methods and values for sterilization wrap made of
- single-use creped paper
- single-use nonwoven materials
- reusable woven textile materials
used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
- Standard27 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies test methods and values for paper used in the manufacture of single-use paper bags (specified in EN 868-4 [3]) and in the manufacture of single-use pouches and reels (specified in EN 868-5 [4]) used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices by means of sterilization processes that require properties specific to higher temperature sterilization, such as moist heat sterilization used in healthcare facilities.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 [1], this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
- Standard24 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as:
a) bed frames;
b) bedside tables;
c) transport carts;
d) containers;
e) surgical tables;
f) sterilization containers;
g) surgical clogs;
h) wheelchairs;
i) aids for persons with disabilities.
This document also specifies the performance requirements for the cleaning and disinfection of the WD and its components and accessories.
Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO 15883-4, and ISO 15883-6 do not fall within the scope of this document.
In addition, this document specifies the methods for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control, and monitoring, as well as requalifications to be carried out periodically and after essential repairs.
NOTE 1 WD covered by this document can also be used for cleaning and chemical disinfection of other thermolabile and reusable devices as recommended in the instructions for use (IFU) for those devices.
NOTE 2 The performance requirements specified in this document cannot ensure the inactivation or removal of the causative agent(s) (prion proteins) of transmissible spongiform encephalopathies.
- Standard44 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies test methods and values for single-use paper bags manufactured from paper specified in EN 868-3, used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
- Standard20 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies test methods and values for sealable adhesive coated paper manufactured from paper complying with EN 868-6, used as single-use sterile barrier systems and/or single-use packaging systems for terminally sterilized medical devices by the means of low temperature sterilization processes.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 [2], this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
- Standard31 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies test methods and values for sterilization wrap made of
- single-use creped paper
- single-use nonwoven materials
- reusable woven textile materials
used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
- Standard27 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies test methods and values for paper used in the manufacture of single-use paper bags (specified in EN 868-4 [3]) and in the manufacture of single-use pouches and reels (specified in EN 868-5 [4]) used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices by means of sterilization processes that require properties specific to higher temperature sterilization, such as moist heat sterilization used in healthcare facilities.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 [1], this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
- Standard24 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies test methods and values for paper used in the manufacture of single-use preformed sterile barrier systems and/or packaging systems for terminally sterilized medical devices by means of low temperature sterilization processes.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 [2], this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.
- Standard23 pagesEnglish languagesale 10% offe-Library read for1 day
1.1 This document specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only.
These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities.
1.2 This document specifies minimum requirements:
- for the performance and design of sterilizers intended to deliver an LTSF process capable of sterilizing medical devices;
- for the equipment and controls of these sterilizers which are needed for operation, control and monitoring of the sterilization processes, and which can be used for validation of the sterilization process.
1.3 This document specifies further test equipment and test procedures used to verify conformance of the equipment design and performance specified by this document.
1.4 This document does not specify requirements and tests for decontamination systems for use in rooms, enclosures, or environmental spaces.
- Standard127 pagesEnglish languagesale 10% offe-Library read for1 day
1.1 This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope is limited to medical devices, this document can be applicable to other products and equipment. This document covers radiation processes employing irradiators using: a) the radionuclide 60Co or 137Cs; b) a beam from an electron generator; or c) a beam from an X-ray generator. 1.2 This document is not applicable to processes for inactivating viruses or the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE For information on such processes, see ISO 22442-1, ISO 22442-2, ISO 22442-3, ISO 13022 and ICH Q5A. 1.2.1 This document does not specify requirements for designating a medical device as sterile. NOTE Regional and national requirements can designate medical devices as sterile. See, for example, EN 556-1 or ANSI/AAMI ST67. 1.2.2 This document does not specify a quality management system for the control of all stages of production of medical devices. NOTE It is not a requirement of this document to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, REF Section_sec_4 \r \h Clause 4 08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E000000530065006300740069006F006E005F007300650063005F0034000000 ). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices can require implementation of a complete quality management system and the assessment of that system by a third party. 1.2.3 This document does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release. 1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of irradiation facilities. NOTE Regulations on safety requirements for occupational safety related to radiation can exist in some countries. 1.2.5 This document does not specify requirements for the sterilization of used or reprocessed devices.
- Standard39 pagesEnglish languagesale 15% off
- Standard41 pagesFrench languagesale 15% off
This document specifies requirements for washer-disinfectors (WD) that are intended to be used for emptying, flushing, washing and thermal disinfection of non-critical devices in the form of human waste containers by one operating cycle.
This document is intended to be used in conjunction with the general requirements specified in ISO 15883-1:2024, except for those specified in 4.1.1, and with the requirements of ISO 15883-5:2021, except for those specified in 4.1.2.
- Standard24 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for washer-disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of reusable critical and semi-critical medical devices, such as surgical instruments, anaesthetic equipment, and any non-critical devices used in conjunction with critical and semi-critical medical devices, such as bowls, dishes and receivers, utensils and glassware.
This document is intended to be used in conjunction with the general requirements specified in ISO 15883-1:2024, except those specified in 4.1.1.
NOTE The specified performance requirements of this document cannot ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
- Standard26 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies general performance requirements for washer-disinfectors (WD) and washer-disinfector accessories that are intended to be used for cleaning and disinfection of reusable medical devices. It specifies performance requirements for cleaning and disinfection as well as for the accessories that can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and requalification, periodically and after essential repairs, are also specified.
NOTE 1 The requirements can be applied to WD intended for use with other articles used in the context of medical, dental, pharmaceutical and veterinary practice.
The requirements for WD intended to process specific loads are specified in ISO 15883-2, ISO 15883-3, ISO 15883-4, ISO 15883-6 and ISO 15883-7. For WD intended to process loads of two or more different types, the requirements of the applicable parts of ISO 15883-2, ISO 15883-3, ISO 15883-4, ISO 15883-6 and ISO 15883-7 apply.
This document does not specify requirements intended for machines for use for laundry or general catering purposes.
This document does not include requirements for machines which are intended to sterilize the load, or which are designated as “sterilizers” and addressed in other standards.
The specified performance requirements of this document do not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
NOTE 2 Chemicals in some cleaning agents and disinfectants can react with prion protein in a manner that can inhibit its removal or inactivation. If the presence of prion protein is considered a possibility, then this can influence the choice of cleaning agent and disinfectant.
NOTE 3 This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of a WD. The test methods for demonstration of conformity with the requirements of this document can also be employed by users to demonstrate continued conformity of the installed WD throughout its service life. Guidance on a routine test programme is given in Annex A.
- Standard91 pagesEnglish languagesale 10% offe-Library read for1 day
1.1 This document specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only.
These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities.
1.2 This document specifies minimum requirements:
- for the performance and design of sterilizers intended to deliver an LTSF process capable of sterilizing medical devices;
- for the equipment and controls of these sterilizers which are needed for operation, control and monitoring of the sterilization processes, and which can be used for validation of the sterilization process.
1.3 This document specifies further test equipment and test procedures used to verify conformance of the equipment design and performance specified by this document.
1.4 This document does not specify requirements and tests for decontamination systems for use in rooms, enclosures, or environmental spaces.
- Standard127 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies general performance requirements for washer-disinfectors (WD) and washer-disinfector accessories that are intended to be used for cleaning and disinfection of reusable medical devices. It specifies performance requirements for cleaning and disinfection as well as for the accessories that can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and requalification, periodically and after essential repairs, are also specified.
NOTE 1 The requirements can be applied to WD intended for use with other articles used in the context of medical, dental, pharmaceutical and veterinary practice.
The requirements for WD intended to process specific loads are specified in ISO 15883-2, ISO 15883-3, ISO 15883-4, ISO 15883-6 and ISO 15883-7. For WD intended to process loads of two or more different types, the requirements of the applicable parts of ISO 15883-2, ISO 15883-3, ISO 15883-4, ISO 15883-6 and ISO 15883-7 apply.
This document does not specify requirements intended for machines for use for laundry or general catering purposes.
This document does not include requirements for machines which are intended to sterilize the load, or which are designated as “sterilizers” and addressed in other standards.
The specified performance requirements of this document do not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
NOTE 2 Chemicals in some cleaning agents and disinfectants can react with prion protein in a manner that can inhibit its removal or inactivation. If the presence of prion protein is considered a possibility, then this can influence the choice of cleaning agent and disinfectant.
NOTE 3 This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of a WD. The test methods for demonstration of conformity with the requirements of this document can also be employed by users to demonstrate continued conformity of the installed WD throughout its service life. Guidance on a routine test programme is given in Annex A.
- Standard91 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for washer-disinfectors (WD) that are intended to be used for emptying, flushing, washing and thermal disinfection of non-critical devices in the form of human waste containers by one operating cycle.
This document is intended to be used in conjunction with the general requirements specified in ISO 15883-1:2024, except for those specified in 4.1.1, and with the requirements of ISO 15883-5:2021, except for those specified in 4.1.2.
- Standard24 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for washer-disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of reusable critical and semi-critical medical devices, such as surgical instruments, anaesthetic equipment, and any non-critical devices used in conjunction with critical and semi-critical medical devices, such as bowls, dishes and receivers, utensils and glassware.
This document is intended to be used in conjunction with the general requirements specified in ISO 15883-1:2024, except those specified in 4.1.1.
NOTE The specified performance requirements of this document cannot ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
- Standard26 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as: a) bed frames; b) bedside tables; c) transport carts; d) containers; e) surgical tables; f) sterilization containers; g) surgical clogs; h) wheelchairs; i) aids for persons with disabilities. This document also specifies the performance requirements for the cleaning and disinfection of the WD and its components and accessories. Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO 15883-4, and ISO 15883-6 do not fall within the scope of this document. In addition, this document specifies the methods for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control, and monitoring, as well as requalifications to be carried out periodically and after essential repairs. NOTE 1 WD covered by this document can also be used for cleaning and chemical disinfection of other thermolabile and reusable devices as recommended in the instructions for use (IFU) for those devices. NOTE 2 The performance requirements specified in this document cannot ensure the inactivation or removal of the causative agent(s) (prion proteins) of transmissible spongiform encephalopathies.
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- Standard33 pagesFrench languagesale 15% off
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 languagesale 10% offe-Library read for1 day
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.
- Standard36 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard36 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the requirements for an aseptically processed medical device to be designated “STERILE”.
- Standard17 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for washer-disinfectors (WD) that are intended to be used for emptying, flushing, washing and thermal disinfection of non-critical devices in the form of human waste containers by one operating cycle. This document is intended to be used in conjunction with the general requirements specified in ISO 15883-1:2024, except for those specified in 4.1.1, and with the requirements of ISO 15883-5:2021, except for those specified in 4.1.2.
- Standard11 pagesEnglish languagesale 15% off
- Standard12 pagesFrench languagesale 15% off
This document specifies the requirements for an aseptically processed medical device to be designated “STERILE”.
- Standard17 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for washer-disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of reusable critical and semi-critical medical devices, such as surgical instruments, anaesthetic equipment, and any non-critical devices used in conjunction with critical and semi-critical medical devices, such as bowls, dishes and receivers, utensils and glassware. This document is intended to be used in conjunction with the general requirements specified in ISO 15883-1:2024, except those specified in 4.1.1. NOTE The specified performance requirements of this document cannot ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
- Standard14 pagesEnglish languagesale 15% off
- Standard15 pagesFrench languagesale 15% off
This document specifies general performance requirements for washer-disinfectors (WD) and washer-disinfector accessories that are intended to be used for cleaning and disinfection of reusable medical devices. It specifies performance requirements for cleaning and disinfection as well as for the accessories that can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and requalification, periodically and after essential repairs, are also specified. NOTE 1 The requirements can be applied to WD intended for use with other articles used in the context of medical, dental, pharmaceutical and veterinary practice. The requirements for WD intended to process specific loads are specified in ISO 15883-2, ISO 15883-3, ISO 15883-4, ISO 15883-6 and ISO 15883-7. For WD intended to process loads of two or more different types, the requirements of the applicable parts of ISO 15883-2, ISO 15883-3, ISO 15883-4, ISO 15883-6 and ISO 15883-7 apply. This document does not specify requirements intended for machines for use for laundry or general catering purposes. This document does not include requirements for machines which are intended to sterilize the load, or which are designated as “sterilizers” and addressed in other standards. The specified performance requirements of this document do not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies. NOTE 2 Chemicals in some cleaning agents and disinfectants can react with prion protein in a manner that can inhibit its removal or inactivation. If the presence of prion protein is considered a possibility, then this can influence the choice of cleaning agent and disinfectant. NOTE 3 This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of a WD. The test methods for demonstration of conformity with the requirements of this document can also be employed by users to demonstrate continued conformity of the installed WD throughout its service life. Guidance on a routine test programme is given in Annex A.
- Standard73 pagesEnglish languagesale 15% off
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This document specifies the requirements for a terminally sterilized medical device to be designated ‘STERILE’. Part 2 of this European standard specifies the requirements for an aseptically processed medical device to be designated "STERILE".
NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designation of a medical device as ‘STERILE’ is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN ISO 11135, EN ISO 11137, EN ISO 14160, EN ISO 14937, EN ISO 17665-1, EN ISO 20857, EN ISO 25424 and ISO 22441.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the requirements for a terminally sterilized medical device to be designated ‘STERILE’. Part 2 of this European standard specifies the requirements for an aseptically processed medical device to be designated "STERILE".
NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designation of a medical device as ‘STERILE’ is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN ISO 11135, EN ISO 11137, EN ISO 14160, EN ISO 14937, EN ISO 17665-1, EN ISO 20857, EN ISO 25424 and ISO 22441.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products.
This document includes requirements and guidance relative to the overall topic of aseptic processing.
Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.
- Standard91 pagesEnglish languagesale 10% offe-Library read for1 day
This document provides requirements for the development, validation and routine control of moist heat sterilization processes for medical devices. It also contains guidance which is intended to explain the requirements set forth in the normative sections. The guidance given is intended to promote good practice related to moist heat sterilization processes according to this document. The application within industrial and health care settings is considered.
- Standard172 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies a test method simulating practical conditions for establishing whether a product for hygienic handrub reduces the release of virus contamination 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 document is applicable 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 can occur in the workplace and in the home. It can 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.
- Standard29 pagesEnglish languagesale 10% offe-Library read for1 day
This document provides requirements for the development, validation and routine control of moist heat sterilization processes for medical devices. It also contains guidance which is intended to explain the requirements set forth in the normative sections. The guidance given is intended to promote good practice related to moist heat sterilization processes according to this document. The application within industrial and health care settings is considered.
- Standard172 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products.
This document includes requirements and guidance relative to the overall topic of aseptic processing.
Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.
- Standard91 pagesEnglish languagesale 10% offe-Library read for1 day
1.1 Inclusions
1.1.1 This document provides requirements for the development, validation and routine monitoring and control of a low temperature sterilization process for medical devices using vaporized hydrogen peroxide (VH2O2) as the sterilizing agent.
1.1.2 This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, organizations performing process validation of VH2O2 sterilization, and organizations responsible for sterilizing medical devices.
NOTE VH2O2 sterilizers can be used in both health care and industrial facilities, and this document acknowledges the similarities and differences between the two applications.
1.2 Exclusions
1.2.1 Processes that use other sterilizing agents, or hydrogen peroxide solution in combination with other chemicals as the sterilizing agent are not addressed in this document.
NOTE See ISO 14937 for guidance on validation of such processes.
1.2.2 This document does not specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies, e.g. scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
NOTE Some VH2O2 sterilizers have processes that demonstrate some level of inactivation of the causative agents of spongiform encephalopathies, e.g. scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob Disease. However, this inactivation is process, cycle, and test protocol specific, therefore this inactivation is outside the scope of this document, and no specific test methods are provided (see [14], [26], and [30] for more information).
1.2.3 This document does not specify requirements for designating a medical device as sterile.
NOTE See for example EN 556–1 or ANSI/AAMI ST67.
1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of VH2O2 sterilization equipment.
NOTE For further information on safety, see examples in the Bibliography. National or regional regulations can also exist.
1.2.5 This document does not apply to the contents of contained product, i.e. product for which the environment within the sterilizer chamber during any stage of the sterilization process does not come into direct contact with the product, such as a solution in a sealed bottle.
1.2.6 This document does not cover hydrogen peroxide decontamination systems for use in rooms, enclosures or environmental spaces.
NOTE These decontamination systems operate at ambient conditions (e.g. temperature and pressure) and in general utilise an approach that is different to that of VH2O2 sterilization processes addressed in this document.
- Standard87 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard79 pagesEnglish languagesale 15% off
- Standard85 pagesFrench languagesale 15% off
This document specifies a test method simulating practical conditions for establishing whether a product for hygienic handrub reduces the release of virus contamination 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 document is applicable 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 can occur in the workplace and in the home. It can 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.
- Standard29 pagesEnglish languagesale 10% offe-Library read for1 day