11.080.01 - Sterilization and disinfection in general
ICS 11.080.01 Details
Sterilization and disinfection in general
Sterilisation und Desinfektion im allgemeinen
Stérilisation et désinfection en général
Sterilizacija in dezinfekcija na splošno
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This document describes a method for substantiating a selected sterilization dose of 17,5 kGy, 20 kGy,
22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy that achieves a sterility assurance level (SAL) of 10−6
or less for radiation sterilization of health care products. This document also specifies a method
of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated
sterilization dose.
NOTE 1 Selection and substantiation of the sterilization dose is used to meet the requirements for establishing
the sterilization dose within process definition in ISO 11137-1.
This document does not apply to other sterilization doses than the substantiation of a selected
sterilization dose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy. The method is
not used for the substantiation of a selected sterilization dose if the average bioburden of the entire
product item exceeds the limit specified for the selected sterilization dose (see Table 3).
NOTE 2 The methods for substantiation of selected sterilization doses of 25 kGy and 15 kGy are not included
in this document. They are described in ISO 11137-2.
If the decision is made to use this method of sterilization dose establishment, the method is intended to
be followed in accordance with the requirements (shall) and guidance (should) stipulated herein.
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This document provides additional guidance to that given in ISO 11137‑3 on meeting the requirements specified in ISO 11137‑1, ISO 11137‑2 and ISO/TS 13004 for the establishment and control of a radiation sterilization process using gamma, electron beam, and Xirradiation.
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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.
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Adoption of ISO 13004:2022 – This is currently in FDIS and will be publishing in October 2022.
This document describes a method for substantiating a selected sterilization dose of 17,5,
20, 22,5, 27,5, 30, 32,5 or 35 kGy that achieves a sterility assurance level (SAL) of 10−6 or less for radiation
sterilization of health care products. This Technical Specification also specifies a method of sterilization
dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.
NOTE Selection and substantiation of the sterilization dose is used to meet the requirements for establishing
the sterilization dose within process definition in ISO 11137-1.
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This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in health care products, components or raw materials using bacterial endotoxins test (BET) methods, using amebocyte lysate reagents. This document is not applicable to the evaluation of pyrogens other than bacterial endotoxins. Other endotoxin detection methodologies are not included (see B.12). This document does not address setting specific endotoxin limit specifications.
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This document provides additional guidance to that given in ISO 11137-3 on meeting the requirements specified in ISO 11137-1, ISO 11137-2 and ISO/TS 13004 for the establishment and control of a radiation sterilization process using gamma, electron beam, and X-irradiation.
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This International Standard specifies the performance requirements and test methods for chemical indicators and hollow devices and porous devices within which they are intended to function, to be used for testing the steam penetration performance of type B cycles of small steam sterilizers; small steam sterilizers are defined in EN 13060. The hollow and porous devices described in this standard do not substantiate their suitability as surrogate devices for lumened, hollow and porous medical devices used in health care facilities.
Chemical indicators used with a porous device specified in this standard are designed to demonstrate the adequacy of steam penetration into a porous device in small steam sterilizers (see EN 13060).
The relevant sections of this International Standard covering porous loads specify the requirements for
— a reference porous device to be used in the small load test for porous loads in small steam sterilizers and as a reference device by which alternative porous devices can be shown to be equivalent in performance according to this standard; ie, a textile test pack in which steam penetration is judged by thermometric means;
— an alternative porous device equivalent in performance to the reference porous device; ie, an alternative porous device, usually commercially manufactured, of any design.
Chemical indicator systems used with a hollow load device specified in this standard are designed to demonstrate the adequacy of steam penetration into a hollow device in small steam sterilizers (see EN 13060).
The relevant sections of this International Standard covering hollow loads specify the requirements for
— a reference hollow device used as a reference device in this standard; ie, a lumened device with attached capsule in which steam penetration is judged by inactivation or survival of a specified biological indicator;
— an alternative hollow device employing the same specific test load as defined for the reference hollow device and an indicator system designed specifically for use in the reference hollow test load; ie, a lumened device with an attached capsule in which steam penetration is judged by visual examination of an indicator system;
— an alternative hollow device equivalent in performance to the reference hollow device; ie, an alternative hollow device, usually commercially manufactured, of any design.
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This document provides guidance on the quality of water for sterilizers, sterilization and washer-disinfectors (WDs) used to process health care products. This document covers the quality of water used directly for cleaning, thermal and chemical disinfection, rinsing and sterilization, as feedwater for the generation of steam, as a service to a sterilizer or WD, or as a cooling agent. This document provides specific guidance on: — water quality for different applications; — water treatment systems; — water distribution and storage; — monitoring and control of water quality; — investigating out of specification results. NOTE Guidance given in this document can also be applied to specifications for the quality of water required for manual cleaning or disinfection of medical devices (see the ISO 17664 series). This document does not supersede or modify requirements or test methods of published standards applying to: — development, validation or routine control and monitoring of a sterilization process; — sterilizers; — WDs. This document does not specify requirements for water treatment systems (see, for example, standards for particular sterilizers or WDs). This document does not specify the water quality for manufacturing pharmaceuticals, cell-based health care products or medical devices. This document does not provide guidance on the attributes of steam quality (see, for example, EN 285).
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This document specifies the performance requirements and test methods for hollow devices and porous devices as well as the chemical indicators and biological indicators that are utilized within these devices for testing a specific steam penetration performance of type B cycles and some type S cycles of small steam sterilizers according to EN 13060.
NOTE The hollow and porous devices described in this document are not intended for use as surrogate devices for hollow and porous medical devices used in health care facilities.
a) Chemical indicators used with a porous device specified in this document are designed to demonstrate the adequacy of steam penetration into a porous device in small steam sterilizers (see EN 13060).
This document specifies the requirements for:
— a reference porous device (RPD) as a reference device by which alternative porous indicator systems (APISs) can be shown to be equivalent in performance according to this document, i.e. a textile test pack in which steam penetration is judged by thermometric means;
— an alternative porous chemical indicator system equivalent in performance to the RPD, i.e. an APIS, usually commercially manufactured, of any design.
b) Chemical indicators used with a hollow load device specified in this document are designed to demonstrate the adequacy of steam penetration into a narrow lumen (previously known as hollow load A) in small steam sterilizers (see EN 13060).
This document specifies the requirements for:
— a reference hollow device (RHD) used as a reference device in this document, i.e. a lumened device with attached capsule in which steam penetration is judged by inactivation or survival of a specified biological indicator;
— an alternative hollow device:
— employing the same specific test load as defined for the RHD and a chemical indicator designed specifically for use in the reference hollow test load, i.e. a lumened device with an attached capsule in which steam penetration is judged by visual examination of a chemical indicator;
— equivalent in performance to the RHD, i.e. an alternative hollow device, usually commercially manufactured, of any design.
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This document specifies the performance requirements and test methods for hollow devices and porous devices as well as the chemical indicators and biological indicators that are utilized within these devices for testing a specific steam penetration performance of type B cycles and some type S cycles of small steam sterilizers according to EN 13060. NOTE The hollow and porous devices described in this document are not intended for use as surrogate devices for hollow and porous medical devices used in health care facilities. a) Chemical indicators used with a porous device specified in this document are designed to demonstrate the adequacy of steam penetration into a porous device in small steam sterilizers (see EN 13060). This document specifies the requirements for: — a reference porous device (RPD) as a reference device by which alternative porous indicator systems (APISs) can be shown to be equivalent in performance according to this document, i.e. a textile test pack in which steam penetration is judged by thermometric means; — an alternative porous chemical indicator system equivalent in performance to the RPD, i.e. an APIS, usually commercially manufactured, of any design. b) Chemical indicators used with a hollow load device specified in this document are designed to demonstrate the adequacy of steam penetration into a narrow lumen (previously known as hollow load A) in small steam sterilizers (see EN 13060). This document specifies the requirements for: — a reference hollow device (RHD) used as a reference device in this document, i.e. a lumened device with attached capsule in which steam penetration is judged by inactivation or survival of a specified biological indicator; — an alternative hollow device: — employing the same specific test load as defined for the RHD and a chemical indicator designed specifically for use in the reference hollow test load, i.e. a lumened device with an attached capsule in which steam penetration is judged by visual examination of a chemical indicator; — equivalent in performance to the RHD, i.e. an alternative hollow device, usually commercially manufactured, of any design.
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This document describes a method for substantiating a selected sterilization dose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy that achieves a sterility assurance level (SAL) of 10−6 or less for radiation sterilization of health care products. This document also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose. NOTE 1 Selection and substantiation of the sterilization dose is used to meet the requirements for establishing the sterilization dose within process definition in ISO 11137‑1. This document does not apply to other sterilization doses than the substantiation of a selected sterilization dose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy. The method is not used for the substantiation of a selected sterilization dose if the average bioburden of the entire product item exceeds the limit specified for the selected sterilization dose (see Table 3). NOTE 2 The methods for substantiation of selected sterilization doses of 25 kGy and 15 kGy are not included in this document. They are described in ISO 11137‑2. If the decision is made to use this method of sterilization dose establishment, the method is intended to be followed in accordance with the requirements (shall) and guidance (should) stipulated herein.
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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.
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This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body or a medical device that comes into contact with mucous membranes or non-intact skin) or medical devices that are intended to be sterilized.
This includes information for processing prior to use or reuse of the medical device.
Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable:
a) initial treatment at the point of use;
b) preparation before cleaning;
c) cleaning;
d) disinfection;
e) drying;
f) inspection and maintenance;
g) packaging;
h) sterilization;
i) storage;
j) transportation.
This document excludes processing of the following:
— non-critical medical devices unless they are intended to be sterilized;
— textile devices used in patient draping systems or surgical clothing;
— medical devices specified by the manufacturer for single use only and supplied ready for use.
NOTE See ISO 17664-2:2021, Annex E, for further guidance on the application of the ISO 17664 series to a medical device.
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1.1 This document specifies the requirements for a test method to be utilized to establish or confirm a reduced incubation time (RIT) that is shorter than the 7-day reference incubation time specified in 7.3.2 of ISO 11138-1:2017 for biological indicators used to monitor moist heat sterilization processes or ethylene oxide (EO) sterilization processes.
NOTE: For biological indicators used for EO sterilization, the stated RIT is applicable to 100 % EO processes or processes that use EO blends, regardless of the product load.
1.2 This document is applicable to manufacturers of biological indicators (BIs) and to end users of BIs who intend to, if required by their quality system, establish, validate or confirm a RIT.
1.3 This document does not apply to biological indicators used to monitor dry heat, low temperature steam formaldehyde (LTSF) or vaporized hydrogen peroxide (VH2O2) sterilization processes.
NOTE The method described in this document to establish a RIT for biological indicators used to monitor moist heat or EO sterilization processes has been used extensively for many years. However, there is limited experience in use of this method to establish a RIT for biological indicators used to monitor dry heat, low temperature steam formaldehyde or vaporized hydrogen peroxide sterilization processes. This document, therefore, does not include these sterilization processes.
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This document specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin.
This document covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. Risks associated with other microorganisms can be assessed using other methods (see NOTE 1).
This document is not applicable to material of human origin.
This document does not describe methods for the validation of the inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (see NOTE 2 and NOTE 3).
This document does not describe methods for validation of the inactivation or elimination of protozoa and parasites.
The requirements for validation and routine control described in this document are only applicable to the defined sterilization process of a medical device, which is performed after the manufacturing process, and do not take account of the lethal effects of other bioburden reduction steps (see NOTE 4).
This document does not specify tests to establish the effects of any chosen sterilization process upon the fitness for use of the medical device (see NOTE 5).
This document does not cover the level of residual sterilizing agent within medical devices (see NOTE 6).
Guidance for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin is provided in informative Annex A.
NOTE 1 The prior application of risk management principles to medical devices utilizing animal tissues, as described in ISO 22442-1 is important. ISO 18362 provides information on control of microbial risks during processing of cell-based health-care products.
NOTE 2 Liquid chemical sterilizing agents traditionally employed to sterilize animal tissues in medical devices might not be effective in inactivating the causative agents of TSE such as bovine spongiform encephalopathy (BSE), or scrapie. Satisfactory validation in accordance with this document does not necessarily demonstrate inactivation of infective agents of this type. Risk controls related to sourcing, collection and handling of animal materials are described in ISO 22442-2.
NOTE 3 The validation of the inactivation, elimination, or elimination and inactivation of viruses and TSE agents is described in ISO 22442-3.
NOTE 4 Manufacturing processes for medical devices containing animal tissues frequently include exposure to chemical agents which can significantly reduce the bioburden on the medical device. Following the manufacturing process, a medical device is exposed to a specified sterilization process.
NOTE 5 Such testing is a crucial part of the design and development of a medical device.
NOTE 6 ISO 10993-17 specifies a method to establish allowable limits for residues of sterilizing agents.
NOTE 7 Standards for quality management systems (see ISO 13485) can be used in the control of all stages of manufacture including the sterilization process.
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This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products.
This document does not specify requirements for restricted access barrier systems (RABS).
This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions.
This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application.
This document does not define biosafety containment requirements.
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This document specifies requirements for the information to be provided by the medical device
manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that
enters normally sterile parts of the human body or a medical device that comes into contact with
mucous membranes or non-intact skin) or medical devices that are intended to be sterilized.
This includes information for processing prior to use or reuse of the medical device.
Processing instructions are not defined in this document. Rather, this document specifies requirements
to assist manufacturers of medical devices in providing detailed processing instructions that consist of
the following activities, where applicable:
a) initial treatment at the point of use;
b) preparation before cleaning;
c) cleaning;
d) disinfection;
e) drying;
f) inspection and maintenance;
g) packaging;
h) sterilization;
i) storage;
j) transportation.
This document excludes processing of the following:
— non-critical medical devices unless they are intended to be sterilized;
— textile devices used in patient draping systems or surgical clothing;
— medical devices specified by the manufacturer for single use only and supplied ready for use.
NOTE See ISO 17664-2:2021, Annex E, for further guidance on the application of the ISO 17664 series to a
medical device
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1.1 This document specifies the requirements for a test method to be utilized to establish or confirm a reduced incubation time (RIT) that is shorter than the 7 day reference incubation time specified in 7.3.22 of ISO 11138-1:2017 for biological indicators used to monitor moist heat sterilization processes or ethylene oxide (EO) sterilization processes.
1.2 This document is applicable to manufacturers of biological indicators and to end users of biological indicators who intend to, if required by their quality system, establish, validate or confirm an RIT.
1.3 This document is not applicable to biological indicators used to monitor dry heat, low temperature steam formaldehyde (LTSF) or vaporized hydrogen peroxide (VH2O2) sterilization processes.
NOTE 1 The method described in this document to establish an RIT for biological indicators used to monitor moist heat or EO sterilization processes has been used extensively for many years. However, there is limited experience in use of this method to establish an RIT for biological indicators used to monitor dry heat, low temperature steam formaldehyde or vaporized hydrogen peroxide sterilization processes. This document, therefore, does not include these sterilization processes.
NOTE 2 For EO as a sterilizing agent, the stated RIT will be applicable for any EO cycle type, i.e. 100% EO, EO blends, etc.
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1.1 This document specifies the requirements for a test method to be utilized to establish or confirm a reduced incubation time (RIT) that is shorter than the 7-day reference incubation time specified in 7.3.2 of ISO 11138-1:2017 for biological indicators used to monitor moist heat sterilization processes or ethylene oxide (EO) sterilization processes. NOTE: For biological indicators used for EO sterilization, the stated RIT is applicable to 100 % EO processes or processes that use EO blends, regardless of the product load. 1.2 This document is applicable to manufacturers of biological indicators (BIs) and to end users of BIs who intend to, if required by their quality system, establish, validate or confirm a RIT. 1.3 This document does not apply to biological indicators used to monitor dry heat, low temperature steam formaldehyde (LTSF) or vaporized hydrogen peroxide (VH2O2) sterilization processes. NOTE The method described in this document to establish a RIT for biological indicators used to monitor moist heat or EO sterilization processes has been used extensively for many years. However, there is limited experience in use of this method to establish a RIT for biological indicators used to monitor dry heat, low temperature steam formaldehyde or vaporized hydrogen peroxide sterilization processes. This document, therefore, does not include these sterilization processes.
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This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body or a medical device that comes into contact with mucous membranes or non-intact skin) or medical devices that are intended to be sterilized. This includes information for processing prior to use or reuse of the medical device. Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable: a) initial treatment at the point of use; b) preparation before cleaning; c) cleaning; d) disinfection; e) drying; f) inspection and maintenance; g) packaging; h) sterilization; i) storage; j) transportation. This document excludes processing of the following: — non-critical medical devices unless they are intended to be sterilized; — textile devices used in patient draping systems or surgical clothing; — medical devices specified by the manufacturer for single use only and supplied ready for use. NOTE See ISO 17664-2:2021, Annex E, for further guidance on the application of the ISO 17664 series to a medical device.
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This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products.
This document does not specify requirements for restricted access barrier systems (RABS).
This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions.
This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application.
This document does not define biosafety containment requirements.
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This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products. This document does not specify requirements for restricted access barrier systems (RABS). This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions. This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application. This document does not define biosafety containment requirements.
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1.1.1 This document provides guidance for bioburden testing and tests of sterility for biologics and tissue-based products, where this testing is in relation to product sterilization. NOTE This document is intended to be used in conjunction with ISO 11737-1 and ISO 11737-2. 1.1.2 Guidance in this document can be applicable to biologics and tissue-based products that are not sterile but are microbiologically controlled.
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This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact). This includes information for processing prior to use or reuse of the medical device. Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable: a) preparation before processing; b) cleaning; c) disinfection; d) drying; e) inspection and maintenance; f) packaging; g) storage; h) transportation. This document excludes processing of: 1) critical and semi-critical medical devices; 2) medical devices intended to be sterilized; 3) textile medical devices used in patient draping systems or surgical clothing; 4) medical devices specified by the manufacturer for single use only and supplied ready for use. NOTE See Annex E for further guidance on the application of the ISO 17664 series to a medical device.
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This document specifies the common requirements for sterilizers used for terminal sterilization of medical devices in health care facilities. This document covers sterilizers that operate with a variety of sterilizing agents (alone or in combination) within a sealed vessel at different temperatures, above, at, or below atmospheric pressure. This document provides high-level requirements and respective test methods that are general in nature. This document does not provide quantitative requirements for process parameters or parameters of the sterilization cycle, or requirements for performance testing, validation or routine control of sterilizers because these depend on the respective sterilization method. This document does not supersede or modify requirements or test methods of published standards applying to sterilizers, or future editions thereof. This document does not apply to: — sterilizers using radiation as the sterilizing agent; — sterilizers for laboratory equipment; — sterilizers used to prepare culture media; — sterilizers used for bio-decontamination of laboratory or other waste including decontamination of pathogens in a high risk category; — systems used for bio-decontamination of rooms and isolator systems; — systems used for sterilization in place; or — washer-disinfectors. NOTE Whilst this document provides requirements for sterilizers used in health care applications, there will be elements that are applicable to industrial applications.
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1.1 This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.
1.2 This document is not applicable to:
a) sterility testing for routine release of product that has been subjected to a sterilization process,
b) performing a test for sterility (see 3.12),
NOTE 1 The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 11137-2, ISO 14160, ISO 14937, ISO 17665-1 or ISO 20857.
c) test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity, and
d) culturing of biological indicators or inoculated products.
NOTE 2 Guidance on culturing biological indicators is included in ISO 11138-7.
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This document specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin. This document covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. Risks associated with other microorganisms can be assessed using other methods (see NOTE 1). This document is not applicable to material of human origin. This document does not describe methods for the validation of the inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (see NOTE 2 and NOTE 3). This document does not describe methods for validation of the inactivation or elimination of protozoa and parasites. The requirements for validation and routine control described in this document are only applicable to the defined sterilization process of a medical device, which is performed after the manufacturing process, and do not take account of the lethal effects of other bioburden reduction steps (see NOTE 4). This document does not specify tests to establish the effects of any chosen sterilization process upon the fitness for use of the medical device (see NOTE 5). This document does not cover the level of residual sterilizing agent within medical devices (see NOTE 6). Guidance for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin is provided in informative Annex A. NOTE 1 The prior application of risk management principles to medical devices utilizing animal tissues, as described in ISO 22442-1 is important. ISO 18362 provides information on control of microbial risks during processing of cell-based health-care products. NOTE 2 Liquid chemical sterilizing agents traditionally employed to sterilize animal tissues in medical devices might not be effective in inactivating the causative agents of TSE such as bovine spongiform encephalopathy (BSE), or scrapie. Satisfactory validation in accordance with this document does not necessarily demonstrate inactivation of infective agents of this type. Risk controls related to sourcing, collection and handling of animal materials are described in ISO 22442-2. NOTE 3 The validation of the inactivation, elimination, or elimination and inactivation of viruses and TSE agents is described in ISO 22442-3. NOTE 4 Manufacturing processes for medical devices containing animal tissues frequently include exposure to chemical agents which can significantly reduce the bioburden on the medical device. Following the manufacturing process, a medical device is exposed to a specified sterilization process. NOTE 5 Such testing is a crucial part of the design and development of a medical device. NOTE 6 ISO 10993-17 specifies a method to establish allowable limits for residues of sterilizing agents. NOTE 7 Standards for quality management systems (see ISO 13485) can be used in the control of all stages of manufacture including the sterilization process.
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This document provides guidance on the requirements of ISO 11135 that apply when parametric release is used to release the product after exposure to the sterilization process. It provides a path for transition of existing cycles, as well as a path for the development and implementation of a parametric release specification for a new cycle. Additionally, it highlights the importance and interrelationship of other process factors, i.e. load configuration and equipment performance, which influence reproducibility of an ethylene oxide (EO) sterilization process. NOTE For ease of reference, the numbering of clauses in this document corresponds to that in the normative parts of ISO 11135. No additional guidance is offered for processes where the declaration of adequacy of the validated sterilization cycle includes a requirement for no growth in biological indicators (BIs) exposed to that process.
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This document provides additional guidance to that given in ISO 11137-3 on meeting the requirements specified in ISO 11137-1, ISO 11137-2 and ISO/TS 13004 for the establishment and control of a radiation sterilization process using gamma, electron beam, and X-irradiation.
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EN-ISO 11737-2 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process. This document is not applicable to: a) sterility testing for routine release of product that has been subjected to a sterilization process, b) performing a test for sterility. c) test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity, and d) culturing of biological indicators or inoculated products.
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1.1 Inclusions
1.1.1 This document specifies requirements for the development, validation and routine control of a low temperature steam and formaldehyde (LTSF) sterilization process for medical devices using a mixture of low temperature steam and formaldehyde as sterilizing agent and which operates below ambient pressure.
NOTE Although the scope of this document is limited to medical devices, it specifies requirements and provides guidance that can be applicable to other products and equipment.
1.1.2 This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices (see ISO 14937:2009, Table E.1).
1.2 Exclusions
1.2.1 This document does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as 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 See ISO 22442‑1, ISO 22442‑2 and ISO 22442‑3.
1.2.2 This document does not specify requirements for designating a medical device as "STERILE". Such requirements are given in EN 556‑1.
1.2.3 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 or reprocessing, but those elements of such a system that are required are normatively referenced at appropriate places in the text. Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices including the sterilization process. Further guidance is given in E.4 of ISO 14937:2009.
1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of LTSF sterilization facilities.
NOTE 1 Safety requirements for sterilizers are specified in IEC 61010‑2‑040.
NOTE 2 Attention is also drawn to the existence in some countries of regulations stipulating safety requirements.
1.2.5 This document does not cover analytical methods for determining levels or residues of formaldehyde and/or its reaction products.
NOTE 1 Attention is drawn to EN 14180.
NOTE 2 Attention is drawn to the possible existence in some countries of statutory regulations specifying limits for the level of formaldehyde residues on medical devices and products.
1.2.6 This document does not cover preparatory measures that might be necessary before sterilization such as cleaning, disinfection and packing.
NOTE For reprocessable medical devices, the manufacturer(s) of these devices can supply information on the preparatory measures (see ISO 17664).
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20191119 - Negative assessment addressed through BT decision C168/2019 (SV)
2019-03-07-JO- under HAS assessment at PUB stage. E&Y Report was due on 03 March 2019- Awaiting for the assessment report E&Y Report
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20191119 - Negative assessment addressed through BT decision C168/2019 (SV)
2019-03-07-JO- under HAS assessment at PUB stage. E&Y Report was due on 03 March 2019. Awaiting for assessement report from E&Y.
2018-10-17 - TAN : Lack of compliance
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20191119 - Negative assessment addressed through BT decision C168/2019 (SV)
2019-03-07-JO- under HAS assessment at PUB stage. E&Y Report was due on 03 March 2019- Awaiting for the assessment report E&Y Report
- Amendment19 pagesEnglish languagesale 10% offe-Library read for1 day
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20191119 - Negative assessment addressed through BT decision C168/2019 (SV)
2019-03-07-JO- under HAS assessment at PUB stage. E&Y Report was due on 03 March 2019. Awaiting for assessement report from E&Y.
2018-10-17 - TAN : Lack of compliance
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This Standard specifies requirements for the development, validation and routine control of a low temperature steam and formaldehyde (LTSF) sterilization process for medical devices using a mixture of low temperature steam and formaldehyde as sterilizing agent and which operates below ambient pressure. This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices (see ISO 14937:2009, Table E.1).
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- Draft49 pagesEnglish languagesale 10% offe-Library read for1 day
1.1 This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process. 1.2 This document is not applicable to: a) sterility testing for routine release of product that has been subjected to a sterilization process, b) performing a test for sterility (see 3.12), NOTE 1 The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 11137-2, ISO 14160, ISO 14937, ISO 17665-1 or ISO 20857. c) test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity, and d) culturing of biological indicators or inoculated products. NOTE 2 Guidance on culturing biological indicators is included in ISO 11138-7.
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This document provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.
It does not consider those processes that rely solely on physical removal of microorganisms, e.g. filtration.
It is not applicable to combination processes using, for example, washer-disinfectors or flushing and steaming of pipelines.
It does not specify requirements for the selection and use of biological indicators intended to monitor vaporised hydrogen peroxide processes for isolator and room biodecontamination processes at atmospheric pressure.
It is not applicable to liquid immersion sterilization processes.
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This International Standard describes how to digitally exchange soil-related data. It aims to facilitate the exchange of valid, clearly described and specified soil-related data between individuals and organizations via digital systems, and enables any soil data producer, holder or user to find and transfer data in an unambiguous way. This International Standard contains definitions of features, several parameter specifications and encoding rules that allow consistent and retrievable data exchange. It also allows the explicit georeferencing of soil data by building on other International Standards, thus facilitating the use of soil data within geographical information systems (GIS). Because soil data are of various origins and are obtained according to a huge variety of description and classification systems, this International Standard provides no attribute catalogue, but a flexible approach to the unified encoding of soil data by implementing the provisions of ISO 19156 observations and measurements (OM) for use in soil science.
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This document provides guidance for the selection, use and interpretation of results from application of
biological indicators when used in the development, validation and routine monitoring of sterilization
processes.
It does not consider those processes that rely solely on physical removal of microorganisms, e.g.
filtration.
It is not applicable to combination processes using, for example, washer-disinfectors or flushing and
steaming of pipelines.
It does not specify requirements for the selection and use of biological indicators intended to monitor
vaporised hydrogen peroxide processes for isolator and room biodecontamination processes at
atmospheric pressure.
It is not applicable to liquid immersion sterilization processes.
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