11.080.10 - Sterilizing equipment
ICS 11.080.10 Details
Sterilizing equipment
Sterilisiergerate. Desinfiziergerate
Matériel de stérilisation et de désinfection
Sterilizacijska oprema
General Information
Frequently Asked Questions
ICS 11.080.10 is a classification code in the International Classification for Standards (ICS) system. It covers "Sterilizing equipment". 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 154 standards classified under ICS 11.080.10 (Sterilizing equipment). 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 particular requirements for washer-disinfectors (WD) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which specifies general requirements for WD.
The range of products on which WD of this particular type can be used is restricted to non-invasive and non-critical devices and equipment (i.e. not penetrating skin or contacting mucosal surfaces).
NOTE Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam, or combination of the two.
This document does not cover powered devices, lumened devices, and other semi-critical and critical medical devices.
Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO 15883-4, and ISO 15883-7 do not fall within the scope of this document.
- Standard20 pagesEnglish languagee-Library read for1 day
This document specifies particular requirements for washer-disinfectors (WD) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which specifies general requirements for WD.
The range of products on which WD of this particular type can be used is restricted to non-invasive and non-critical devices and equipment (i.e. not penetrating skin or contacting mucosal surfaces).
NOTE Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam, or combination of the two.
This document does not cover powered devices, lumened devices, and other semi-critical and critical medical devices.
Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO 15883-4, and ISO 15883-7 do not fall within the scope of this document.
- Standard20 pagesEnglish languagee-Library read for1 day
This document specifies particular requirements for washer-disinfectors (WD) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which specifies general requirements for WD. The range of products on which WD of this particular type can be used is restricted to non-invasive and non-critical devices and equipment (i.e. not penetrating skin or contacting mucosal surfaces). NOTE Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam, or combination of the two. This document does not cover powered devices, lumened devices, and other semi-critical and critical medical devices. Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO 15883-4, and ISO 15883-7 do not fall within the scope of this document.
- Standard8 pagesEnglish languagesale 15% off
- Standard8 pagesFrench languagesale 15% off
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 languagee-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 languagee-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 languagee-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 languagee-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 languagee-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 languagee-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 languagee-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 languagee-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 languagee-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 languagee-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 languagee-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 languagee-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.
- Standard30 pagesEnglish languagesale 15% off
- Standard33 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.
- Standard11 pagesEnglish languagesale 15% off
- Standard12 pagesFrench languagesale 15% off
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
- Standard77 pagesFrench languagesale 15% off
IEC 61010-2-040:2020 is available as IEC 61010-2-040:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 61010-2-040:2020 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields, when used under the environmental conditions of 1.4. Examples of such equipment include the following:
- sterilizers and disinfectors using steam and/or hot water as the sterilant;
- sterilizers and disinfectors using toxic gas, toxic aerosol or toxic vapour as the sterilant;
- sterilizers and disinfectors using hot air or hot inert gas as the sterilant; and
- washer-disinfectors.
This third edition cancels and replaces the second edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
- it is established on the basis of the third edition (2010) of IEC 61010‑1 and its Amendment 1 (2016);
- added tolerance for stability of a.c. voltage test equipment to 6.8.3.1;
- the status of a Group Safety Publication has been removed (this does not change the technical requirements in the document).
- Standard42 pagesEnglish languagee-Library read for1 day
This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads.
This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l.
Large steam sterilizers can also be used during the commercial production of medical devices.
This European Standard does not specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process biological waste or human tissues.
This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer.
NOTE 1 Attention is drawn to the standards for quality management systems e.g. EN ISO 13485.
NOTE 2 Environmental aspects are addressed in Annex A.
- Standard118 pagesEnglish languagee-Library read for1 day
This document specifies procedures and test methods used to demonstrate the cleaning efficacy of washer-disinfectors (WD) and their accessories intended to be used for cleaning of reusable medical devices.
NOTE 1 The requirements can be used for washer-disinfectors intended for use with other articles used in the context of medical, dental, laboratory, pharmaceutical and veterinary practice.
NOTE 2 This document does not apply to the activities to be performed by the manufacturers of reusable medical devices.
- Standard68 pagesEnglish languagee-Library read for1 day
This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads.
This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l.
Large steam sterilizers can also be used during the commercial production of medical devices.
This European Standard does not specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process biological waste or human tissues.
This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer.
NOTE 1 Attention is drawn to the standards for quality management systems e.g. EN ISO 13485.
NOTE 2 Environmental aspects are addressed in Annex A.
- Standard118 pagesEnglish languagee-Library read for1 day
This document specifies procedures and test methods used to demonstrate the cleaning efficacy of washer-disinfectors (WD) and their accessories intended to be used for cleaning of reusable medical devices.
NOTE 1 The requirements can be used for washer-disinfectors intended for use with other articles used in the context of medical, dental, laboratory, pharmaceutical and veterinary practice.
NOTE 2 This document does not apply to the activities to be performed by the manufacturers of reusable medical devices.
- Standard68 pagesEnglish languagee-Library read for1 day
This document specifies procedures and test methods used to demonstrate the cleaning efficacy of washer-disinfectors (WD) and their accessories intended to be used for cleaning of reusable medical devices. NOTE 1 The requirements can be used for washer-disinfectors intended for use with other articles used in the context of medical, dental, laboratory, pharmaceutical and veterinary practice. NOTE 2 This document does not apply to the activities to be performed by the manufacturers of reusable medical devices.
- Standard59 pagesEnglish languagesale 15% off
- Standard59 pagesEnglish languagesale 15% off
- Standard63 pagesFrench languagesale 15% off
- Standard63 pagesFrench languagesale 15% off
This document specifies the particular requirements, including performance criteria for washer-disinfectors (WD) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes.
This document also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which can be required to achieve the necessary performance criteria.
The methods, instrumentation and instructions required for type testing, works testing, validation (installation, operational and performance qualification on first installation), routine control and monitoring, and requalification of WD periodically and after essential repairs, are also specified.
NOTE 1 In addition, Annex A gives guidance on an appropriate division of responsibility for the range of activities covered by this document.
NOTE 2 WD complying with this document can also be used for cleaning and chemical disinfection of other thermolabile re-usable medical devices for which the device manufacturer has recommended and validated this method of disinfection.
WD complying with the requirements of this document are not intended for cleaning and disinfection of medical devices, including endoscopic accessories, which are heat stable and can be disinfected or sterilized by thermal methods (see ISO 15883-1:2006+Amd 1:2014, 4.1.5).
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 3 If it is considered that prion protein might be present, particular care is needed in the choice of cleaning agents and disinfectants to ensure that the chemicals used do not react with the prion protein and/or other protein in a manner that can inhibit its removal or inactivation from the load or washer-disinfector.
NOTE 4 This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of the WD, manufacturers of endoscopes, cleaning products, and disinfecting products.
- Standard95 pagesEnglish languagee-Library read for1 day
This document specifies the particular requirements, including performance criteria for washer-disinfectors (WD) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes.
This document also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which can be required to achieve the necessary performance criteria.
The methods, instrumentation and instructions required for type testing, works testing, validation (installation, operational and performance qualification on first installation), routine control and monitoring, and requalification of WD periodically and after essential repairs, are also specified.
NOTE 1 In addition, Annex A gives guidance on an appropriate division of responsibility for the range of activities covered by this document.
NOTE 2 WD complying with this document can also be used for cleaning and chemical disinfection of other thermolabile re-usable medical devices for which the device manufacturer has recommended and validated this method of disinfection.
WD complying with the requirements of this document are not intended for cleaning and disinfection of medical devices, including endoscopic accessories, which are heat stable and can be disinfected or sterilized by thermal methods (see ISO 15883-1:2006+Amd 1:2014, 4.1.5).
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 3 If it is considered that prion protein might be present, particular care is needed in the choice of cleaning agents and disinfectants to ensure that the chemicals used do not react with the prion protein and/or other protein in a manner that can inhibit its removal or inactivation from the load or washer-disinfector.
NOTE 4 This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of the WD, manufacturers of endoscopes, cleaning products, and disinfecting products.
- Standard95 pagesEnglish languagee-Library read for1 day
This document specifies the particular requirements, including performance criteria for washer-disinfectors (WD) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes. This document also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which can be required to achieve the necessary performance criteria. The methods, instrumentation and instructions required for type testing, works testing, validation (installation, operational and performance qualification on first installation), routine control and monitoring, and requalification of WD periodically and after essential repairs, are also specified. NOTE 1 In addition, Annex A gives guidance on an appropriate division of responsibility for the range of activities covered by this document. NOTE 2 WD complying with this document can also be used for cleaning and chemical disinfection of other thermolabile re-usable medical devices for which the device manufacturer has recommended and validated this method of disinfection. WD complying with the requirements of this document are not intended for cleaning and disinfection of medical devices, including endoscopic accessories, which are heat stable and can be disinfected or sterilized by thermal methods (see ISO 15883-1:2006+Amd 1:2014, 4.1.5). 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 3 If it is considered that prion protein might be present, particular care is needed in the choice of cleaning agents and disinfectants to ensure that the chemicals used do not react with the prion protein and/or other protein in a manner that can inhibit its removal or inactivation from the load or washer-disinfector. NOTE 4 This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of the WD, manufacturers of endoscopes, cleaning products, and disinfecting products.
- Standard81 pagesEnglish languagesale 15% off
- Standard81 pagesEnglish languagesale 15% off
- Standard81 pagesFrench languagesale 15% off
- Standard81 pagesFrench languagesale 15% off
This European Standard specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases, being used for the sterilization of medical devices and their accessories.
This European Standard specifies requirements for ethylene oxide sterilizers (EO-sterilizers) working at super or sub-atmospheric pressure for:
- the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices;
- the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.
The test loads described in this European Standard are selected to represent a number of loads for the evaluation of the performance of EO sterilizers for medical devices. However, specific loads may require the use of other test loads.
This European Standard does not specify those tests which are necessary to determine the probability of a processed product being sterile, nor the routine quality control tests required prior to release of sterile product. These topics are addressed in prEN ISO 11135:2012.
This European Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities.
NOTE 1 For further information on safety, see examples in the Bibliography. National or regional regulations can exist.
This European Standard does not cover sterilizers which employ the injection of EO or mixtures containing EO directly into packages or into a flexible chamber.
NOTE 2 See EN ISO 14937.
This European Standard is not intended as a checklist for suitability of an existing EO sterilizer when assessing compliance with prEN ISO 11135:2012. This standard is not intended to be applied retrospectively.
This European Standard does not cover analytical methods for determining levels of residual EO and/or its reaction products.
NOTE 3 For further information see ISO 10993 7.
- Standard49 pagesEnglish languagee-Library read for1 day
This European Standard specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases, being used for the sterilization of medical devices and their accessories.
This European Standard specifies requirements for ethylene oxide sterilizers (EO-sterilizers) working at super or sub-atmospheric pressure for:
- the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices;
- the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.
The test loads described in this European Standard are selected to represent a number of loads for the evaluation of the performance of EO sterilizers for medical devices. However, specific loads may require the use of other test loads.
This European Standard does not specify those tests which are necessary to determine the probability of a processed product being sterile, nor the routine quality control tests required prior to release of sterile product. These topics are addressed in prEN ISO 11135:2012.
This European Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities.
NOTE 1 For further information on safety, see examples in the Bibliography. National or regional regulations can exist.
This European Standard does not cover sterilizers which employ the injection of EO or mixtures containing EO directly into packages or into a flexible chamber.
NOTE 2 See EN ISO 14937.
This European Standard is not intended as a checklist for suitability of an existing EO sterilizer when assessing compliance with prEN ISO 11135:2012. This standard is not intended to be applied retrospectively.
This European Standard does not cover analytical methods for determining levels of residual EO and/or its reaction products.
NOTE 3 For further information see ISO 10993 7.
- Standard49 pagesEnglish languagee-Library read for1 day
This European Standard specifies performance criteria for steam sterilizer and autoclave used for the destruction and prevention of release of microorganisms used in biotechnological processes. This European Standard applies if the intended use of steam sterilizers or autoclaves includes hazardous or potentially hazardous microorganisms used in biotechological processes or if exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.
- Standard13 pagesEnglish languagee-Library read for1 day
Specifies the requirements and the relevant tests for sterilizers intended to be used for the terminal sterilization of health care products (medical devices or medicinal products) presented as aqueous liquid in sealed containers. The container can be rigid, semi rigid or flexible. The sterilizing agent, moist heat, is created internally from the product, heating being achieved by use of saturated steam, mixtures of steam and a pressure ballasting non-condensing gas such as air or super-heated water in the sterilizer chamber. The sterilizers can be used in both a health care and industrial setting.
This standard does not apply to sterilizers using saturated steam for the sterilization of the surfaces of medical devices or sterilizers used in laboratories.
NOTE 1 Sterilizers using saturated steam for sterilizing the surfaces of medical devices are covered by EN 285 and EN 13060. Laboratory sterilizers are covered by some national standards.
NOTE 2 Sterilizers conforming to NWIP ISO XXXXX can also be used for the sterilization of other aqueous liquid in sealed containers such as veterinary products or some foodstuffs.
Note 3 Sterilizers conforming to NWIP ISO XXXXX can also be used for the sterilization of a contained product enclosed within a sterile barrier system conforming to the EN ISO 11607 series of standards.
- Draft118 pagesEnglish languagee-Library read for1 day
1.1 This document specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases (for example carbon dioxide or nitrogen) being used for the sterilization of medical devices and their accessories.
1.2 This document specifies requirements for ethylene oxide sterilizers (EO sterilizers) for:
- the performance and design of sterilizers intended to deliver a process capable of sterilizing medical devices;
- the equipment and controls of these sterilizers, needed for operation, control and monitoring of the sterilization processes;
- the test equipment and test procedures used to verify the sterilizer performance specified by this document.
1.3 This document does not cover sterilizers which employ the injection of EO or mixtures containing EO directly into packages or into a flexible chamber.
- Draft116 pagesEnglish languagee-Library read for1 day
This document specifies requirements and tests for low temperature hydrogen peroxide sterilizers, which use a vaporized aqueous solution of hydrogen peroxide as the sterilizing agent.
These sterilizers are used for the sterilization of medical devices, particularly thermolabile medical devices.
This document specifies minimum requirements
• for the performance and design of sterilizers intended to deliver a process capable of sterilizing medical devices;
• for the equipment and controls of these sterilizers needed for operation, control and monitoring, and which can be used for validation of the sterilization processes;
• for the test equipment and test procedures used to verify the sterilizer performance specified by this document.
This document does not specify requirements for equipment intended to process liquids, biological waste, or human tissues.
This document does not describe a quality management system for the control of all stages of the manufacture of the sterilizer.
This document does not specify requirements and tests for decontamination systems for use in rooms, enclosures, or environmental spaces.
NOTE 1 Attention is drawn to the standards for quality management, e.g. EN ISO 13485.
NOTE 2 Environmental aspects of this standard are addressed in Annex H.
- Draft125 pagesEnglish languagee-Library read for1 day
Specifies the requirements and the relevant tests for sterilizers intended to be used for the terminal sterilization of health care products (medical devices or medicinal products) presented as aqueous liquid in sealed containers. The container can be rigid, semi rigid or flexible. The sterilizing agent, moist heat, is created internally from the product, heating being achieved by use of saturated steam, mixtures of steam and a pressure ballasting non-condensing gas such as air or super-heated water in the sterilizer chamber. The sterilizers can be used in both a health care and industrial setting.
This standard does not apply to sterilizers using saturated steam for the sterilization of the surfaces of medical devices or sterilizers used in laboratories.
NOTE 1 Sterilizers using saturated steam for sterilizing the surfaces of medical devices are covered by EN 285 and EN 13060. Laboratory sterilizers are covered by some national standards.
NOTE 2 Sterilizers conforming to NWIP ISO XXXXX can also be used for the sterilization of other aqueous liquid in sealed containers such as veterinary products or some foodstuffs.
Note 3 Sterilizers conforming to NWIP ISO XXXXX can also be used for the sterilization of a contained product enclosed within a sterile barrier system conforming to the EN ISO 11607 series of standards.
- Draft118 pagesEnglish languagee-Library read for1 day
1.1 This document specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases (for example carbon dioxide or nitrogen) being used for the sterilization of medical devices and their accessories.
1.2 This document specifies requirements for ethylene oxide sterilizers (EO sterilizers) for:
- the performance and design of sterilizers intended to deliver a process capable of sterilizing medical devices;
- the equipment and controls of these sterilizers, needed for operation, control and monitoring of the sterilization processes;
- the test equipment and test procedures used to verify the sterilizer performance specified by this document.
1.3 This document does not cover sterilizers which employ the injection of EO or mixtures containing EO directly into packages or into a flexible chamber.
- Draft116 pagesEnglish languagee-Library read for1 day
This document specifies requirements and tests for low temperature hydrogen peroxide sterilizers, which use a vaporized aqueous solution of hydrogen peroxide as the sterilizing agent.
These sterilizers are used for the sterilization of medical devices, particularly thermolabile medical devices.
This document specifies minimum requirements
• for the performance and design of sterilizers intended to deliver a process capable of sterilizing medical devices;
• for the equipment and controls of these sterilizers needed for operation, control and monitoring, and which can be used for validation of the sterilization processes;
• for the test equipment and test procedures used to verify the sterilizer performance specified by this document.
This document does not specify requirements for equipment intended to process liquids, biological waste, or human tissues.
This document does not describe a quality management system for the control of all stages of the manufacture of the sterilizer.
This document does not specify requirements and tests for decontamination systems for use in rooms, enclosures, or environmental spaces.
NOTE 1 Attention is drawn to the standards for quality management, e.g. EN ISO 13485.
NOTE 2 Environmental aspects of this standard are addressed in Annex H.
- Draft125 pagesEnglish languagee-Library read for1 day
This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads.
This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l.
Large steam sterilizers can also be used during the commercial production of medical devices.
This European Standard does not specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process biological waste or human tissues.
This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer.
NOTE 1 Attention is drawn to the standards for quality management systems e.g. EN ISO 13485.
NOTE 2 Environmental aspects are addressed in Annex A.
- Draft4 pagesEnglish languagee-Library read for1 day
This European Standard specifies general performance requirements for washer- disinfectors and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfection as well as the accessories which may be required to achieve the necessary performance.
- Draft90 pagesEnglish languagee-Library read for1 day
This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads.
This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l.
Large steam sterilizers can also be used during the commercial production of medical devices.
This European Standard does not specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process biological waste or human tissues.
This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer.
NOTE 1 Attention is drawn to the standards for quality management systems e.g. EN ISO 13485.
NOTE 2 Environmental aspects are addressed in Annex A.
- Draft4 pagesEnglish languagee-Library read for1 day
This European Standard specifies requirements and tests for low temperature hydrogen peroxide sterilizers, which use a vaporized aqueous solution of hydrogen peroxide as the sterilizing agent.
These sterilizers are used for the sterilization of medical devices, particularly thermolabile medical devices.
This European Standard specifies minimum requirements
- for the performance and design of sterilizers intended to deliver a process capable of sterilizing medical devices;
- for the equipment and controls of these sterilizers needed for operation, control and monitoring, and which can be used for validation of the sterilization processes;
- for the test equipment and test procedures used to verify the sterilizer performance specified by this European Standard.
This European Standard does not specify requirements for equipment intended to process liquids, biological waste or human tissues.
This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer.
This European Standard does not specify requirements and tests for decontamination systems for use in rooms, enclosures or environmental spaces.
NOTE 1 Attention is drawn to the standards for quality management, e.g. EN ISO 13485.
NOTE 2 Environmental aspects of this standard are addressed in Annex H.
- Draft88 pagesEnglish languagee-Library read for1 day
This European Standard 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 European Standard 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 European Standard 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 European Standard does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products.
This European Standard does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases).
This European Standard 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 1.
This European Standard does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).
- Draft4 pagesEnglish languagee-Library read for1 day
2009-08-04 EMA: Missing 3-year timeframe added.
- Draft5 pagesEnglish languagee-Library read for1 day
2008-11-04 SJ: WI approved by BT + derogation from 4 year rule for amendments: BT C 64/2008.
- Draft8 pagesEnglish languagee-Library read for1 day
- Draft6 pagesEnglish languagee-Library read for1 day
- Draft6 pagesEnglish languagee-Library read for1 day
This European Standard 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 European Standard 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 European Standard applies to small steam sterilizers used primarily for the sterilization of medical devices and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm) and with a chamber volume not exceeding 60 litres.
This European Standard does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products.
This European Standard does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases).
This European Standard 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 554, which may also be applied for small steam sterilizers.
- Draft5 pagesEnglish languagee-Library read for1 day
- Draft7 pagesEnglish languagee-Library read for1 day
SCOPE
1.1 This test method covers a reproducible procedure for testing processes used to sterilize reusable medical devices (instruments). This test method is not designed to validate a sterilization process, but tests an established sterilization cycle or process. It is a practical test of the effectiveness of a sterilization process applied to reusable medical devices. Bacterial spores more resistant to the test sterilant than the natural bioburden of the instrument are used as the test organisms. Commercially available liquid suspensions of bacterial spores are used to inoculate the instruments.
1.2 This test method is intended for reusable medical devices cleaned in accordance with the device manufacturer's instructions and prepared for sterilization in accordance with the instructions for the sterilization process being used.
1.3 This test method assumes that cleaned, reusable medical devices will be free of visible soil but may have remaining adherent bioburden. A worst-case bioburden can be represented by suspensions of bacterial endospores, which are commercially available for monitoring chemical or physical sterilization processes. These endospores should have a verifiable resistance (D value) to the specific process and sterilant being evaluated.
1.4 It is impractical to test for the sterility of some devices by immersion in growth medium because of their complexity, size, and availability (for long-term incubation) or adverse effects on the devices from long-term immersion. Therefore, elution, rinsing, or swabbing techniques are used to recover test organisms from inoculated devices.
1.5 A recovery control will be included by inoculation of a test device and use of the elution methods without applying the sterilization process being tested. A minimal recovery of 106 colony-forming unit (CFU)/mL per device is required for the recovery control.
1.6 Results of the recovery control and process test cycle are compared to determine the effectiveness of the sterilization process.
1.7 Results of the recovery control and applied inoculum are compared to determine the recovery efficiency, if desired.
1.8 The procedure should reveal that tested devices are free of recoverable microorganisms when five or more consecutive tests are conducted.
1.9 A knowledge of microbiological techniques is required to conduct these procedures.
1.10 The values stated in SI units are to be regarded as the standard.
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 and health practices and determine the applicability of regulatory limitations prior to use.
- Standard4 pagesEnglish languagesale 15% off
- Draft6 pagesEnglish languagee-Library read for1 day