11.080.99 - Other standards related to sterilization and disinfection
ICS 11.080.99 Details
Other standards related to sterilization and disinfection
Weitere Sterilisations- und Desinfektionsaspekte
Autres normes de sterilisation et de desinfection
Drugi standardi v zvezi s sterilizacijo in dezinfekcijo
General Information
Frequently Asked Questions
ICS 11.080.99 is a classification code in the International Classification for Standards (ICS) system. It covers "Other standards related to sterilization and disinfection". 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 23 standards classified under ICS 11.080.99 (Other standards related to sterilization and disinfection). 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.
2022-06-21 - lack of compliance - publication on hold
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2022-06-21 - lack of compliance - publication on hold
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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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SIGNIFICANCE AND USE
5.1 This test method may be employed to check the sterility of commercially procured sterile membrane filters. The test also confirms that sterilized filters have not been contaminated. Additionally, this test may be used to monitor the efficacy of in-house sterilization procedures. Filter packages that have obvious packaging defects should not be tested because sterility may have been compromised.
SCOPE
1.1 This test method describes a test to confirm the sterility of either manufacturer presterilized or user-sterilized analytical membrane filters.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SIGNIFICANCE AND USE
5.1 This guide may be used by medical device manufacturers as part of their design plan and implementation of the validation of the cleaning instructions of their reusable medical devices.
5.2 This guide helps medical device manufacturers to identify the best method(s) for extracting simulated-use test soil (see Guide F3208), thereby evaluating whether the medical device can be adequately cleaned.
5.3 Methods describing various techniques for extracting soil are given.
5.4 Guidance is further given as to how to validate the method(s) for extraction.
SCOPE
1.1 This guide provides methods and considerations for extracting test soil(s) from reusable medical device(s) that occurs during simulated use validation, clinical use of the device(s) and after the device(s) have been through a cleaning process.
1.2 This is a part of a series of ASTM guides for validating cleaning instructions. The scope of the first guide in the series is regarding selecting appropriate test soils (Guide F3208). The second in the series (Guide F3293) describes methods that are used to inoculate medical devices with simulated-use test soil(s). This third in the series describes methods for extracting test soils in order to measure residual soil remaining on medical devices after the performance of cleaning procedures.
1.3 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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ISO 11137-3:2017 gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in ISO/TS 13004 relating to dosimetry and its use in development, validation and routine control of a radiation sterilization process.
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This Standard describes a test protocol to determine the compatibility of materials, components, parts, and assemblies with sterilization processes. It is dedicated to test on non-flight hardware only. Any additional requirements that can be imposed by the potential use of
test samples as flight hardware are not covered in this document (e.g. handling requirements). This Standard covers the following:
• Identification of critical test parameters to establish functional integrity of the hardware.
• Typical test protocols.
• Acceptance criteria.
Statements about compatibility of materials and components with sterilization processes in this document are made in general terms only. Other factors for determination of whether a material or component is suitable for a particular mission system application include:
• The potential number of sterilization cycles to which the material/component will be subjected in their live cycle.
• The additional stresses on materials/components introduced when they have become part of a larger unit/equipment/system undergoing sterilization.
• Compatibility of sterilization processes at e.g. materials level. This compatibility does not automatically guarantee that it will perform to
its requirements in an assembly. The final application and possible interactions at higher assembly level are important considerations for qualification.
• Qualification of hardware achieved by specific sterilization parameters. They cannot be necessarily extrapolated to other sterilization parameters, not even within the same sterilization process.
• The drift in performance that can be induced by sterilization processes . This drift can cause equipments to fail to meet their specified performance requirements, even though each individual element/component remains within spec. An example of this is where ‘Select-on-test’ components are used to operate a component over a critically narrow range its full performance.
To assess ultimately the suitability/compatibility of a material or component for an application requires a full consideration of the impact of sterilization processes to which it is subjected during its whole life. This includes sterilization processes it undergoes from the time it is a standalone component/material right through to when it experiences final sterilization as part of the complete system.
This standard may be tailored for the specific characteristic and constrains of a space project in conformance with ECSS-S-ST-00.
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1.1 This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
NOTE Although the scope is limited to medical devices, this document can be applicable to other products and equipment.
This document covers radiation processes employing irradiators using:
a) the radionuclide 60Co or 137Cs;
b) a beam from an electron generator; or
c) a beam from an X-ray generator.
1.2 This document is not applicable to processes for inactivating viruses or the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
NOTE For information on such processes, see ISO 22442-1, ISO 22442-2, ISO 22442-3, ISO 13022 and ICH Q5A.
1.2.1 This document does not specify requirements for designating a medical device as sterile.
NOTE Regional and national requirements can designate medical devices as sterile. See, for example, EN 556-1 or ANSI/AAMI ST67.
1.2.2 This document does not specify a quality management system for the control of all stages of production of medical devices.
NOTE It is not a requirement of this document to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices can require implementation of a complete quality management system and the assessment of that system by a third party.
1.2.3 This document does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release.
1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.
NOTE Regulations on safety requirements for occupational safety related to radiation can exist in some countries.
1.2.5 This document does not specify requirements for the sterilization of used or reprocessed devices.
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1.1 This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
NOTE Although the scope is limited to medical devices, this document can be applicable to other products and equipment.
This document covers radiation processes employing irradiators using:
a) the radionuclide 60Co or 137Cs;
b) a beam from an electron generator; or
c) a beam from an X-ray generator.
1.2 This document is not applicable to processes for inactivating viruses or the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
NOTE For information on such processes, see ISO 22442-1, ISO 22442-2, ISO 22442-3, ISO 13022 and ICH Q5A.
1.2.1 This document does not specify requirements for designating a medical device as sterile.
NOTE Regional and national requirements can designate medical devices as sterile. See, for example, EN 556-1 or ANSI/AAMI ST67.
1.2.2 This document does not specify a quality management system for the control of all stages of production of medical devices.
NOTE It is not a requirement of this document to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices can require implementation of a complete quality management system and the assessment of that system by a third party.
1.2.3 This document does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release.
1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.
NOTE Regulations on safety requirements for occupational safety related to radiation can exist in some countries.
1.2.5 This document does not specify requirements for the sterilization of used or reprocessed devices.
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1.1 This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
NOTE Although the scope of this part of ISO 11137 is limited to medical devices, it specifies requirements and
provides guidance that may be applicable to other products and equipment.
This part of ISO 11137 covers radiation processes employing irradiators using,
a) the radionuclide 60Co or 137Cs,
b) a beam from an electron generator or
c) a beam from an X-ray generator.
1.2 This part of ISO 11137 does not specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
NOTE See, for example, ISO 22442-1, ISO 22442-2 and ISO 22442-3.
1.2.1 This part of ISO 11137 does not detail specified requirements for designating a medical device as sterile.
NOTE Attention is drawn to regional and national requirements for designating medical devices as “sterile.” See, for example, EN 556-1 or ANSI/AAMI ST67.
1.2.2 This part of ISO 11137 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 part of ISO 11137 to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices might require implementation of a complete quality management system and the assessment of that system by a third party.
1.2.3 This part of ISO 11137 does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release.
1.2.4 This part of ISO 11137 does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.
NOTE Attention is also drawn to the existence, in some countries, of regulations laying down safety requirements for occupational safety related to radiation.
1.2.5 This part of ISO 11137 does not specify requirements for the sterilization of used or reprocessed
devices.
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2012-07-10 EMA: Draft for final vote received in ISO/CS (see 2012-07-10 notification in dataservice).
2012-07-03 GVN: MINOR REVISION - MINOR REVISION - MINOR REVISION - MINOR REVISION
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SIGNIFICANCE AND USE
5.1 The efficacy of disinfection technologies can be evaluated on finished products, as well as on developmental items.
5.2 This practice defines procedures for validation of the droplet generator, preparation of the test specimen, application of the challenge virus, enumeration of viable viruses, assessing data quality, and calculation of decontamination efficiency.
5.3 This practice provides defined procedures for creating droplets that approximate those produced by human respiratory secretions, with particular emphasis on droplet size distribution and aerosolization media.
5.4 Safety concerns associated with aerosolizing microbial agents are not addressed as part of this practice. Individual users should consult with their local safety authority, and a detailed biological aerosol safety plan and risk assessment should be conducted prior to using this practice. Users are encouraged to consult the manual Biosafety in Microbiological and Biomedical Laboratories5 published by the U.S. Centers for Disease Control and Prevention (CDC).
5.5 This practice differs from Test Methods E1052 and E2197 in the presentation of virus to the surface. The aforementioned test methods use a liquid inoculum to contaminate carrier surfaces, whereas this practice presents the virus in droplets that are representative of human respiratory secretions
5.6 This practice differs from Practice E2720, because (1) larger droplets are being formed, (2) the droplets will not be completely dried prior to application to surfaces, (3) the droplets can be applied to any surfaces, not just those that are air permeable, and (4) unique equipment is required to create droplets.
SCOPE
1.1 This practice is designed to evaluate decontamination methods (physical, chemical, self-decontaminating materials) when used on surfaces contaminated with virus-containing droplets.
1.2 This practice defines the conditions for simulating respiratory droplets produced by humans and depositing the droplets onto surfaces.
1.3 The practice is specific to influenza viruses but could be adapted for work with other types of respiratory viruses or surrogates.
1.4 This practice is suitable for working with a wide variety of environmental surfaces.
1.5 This practice does not address the performance of decontaminants against microbes expelled via blood splatter, vomit, or fecal contamination.
1.6 This practice should be performed only by those trained in bioaerosols, microbiology, or virology, or combinations thereof.
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
WITHDRAWN RATIONALE
This practice is designed to evaluate decontamination methods (physical, chemical, self-decontaminating materials) when used on surfaces contaminated with virus-containing droplets.
Formerly under the jurisdiction of Committee E35 on Pesticides, Antimicrobials, and Alternative Control Agents, this practice was withdrawn in April 2024. This standard is being withdrawn without replacement due to its limited use by industry.
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SIGNIFICANCE AND USE
5.1 The efficacy of disinfection technologies can be evaluated on finished products, as well as on developmental items.
5.2 This practice defines procedures for validation of the aerosol generator, preparation of the test specimen, application of the challenge virus, enumeration of viable viruses, assessing data quality, and calculation of decontamination efficacy.
5.3 This practice provides defined procedures for creating droplet nuclei that approximate those produced by human respiratory secretions with particular emphasis on particle size distribution and aerosolization media.
5.4 Safety concerns associated with aerosolizing microbial agents are not addressed as part of this practice. Individual users should consult with their local safety authority, and a detailed biological aerosol safety plan and risk assessment should be conducted prior to using this practice. Users are encouraged to consult the manual Biosafety in Microbiological and Biomedical Laboratories7 published by the U.S. Centers for Disease Control and Prevention (CDC).
5.5 This practice differs from Test Methods E1052 and E2197 in the presentation of the virus to surface. The aforementioned test methods use liquid inoculum to contaminate carrier surfaces, whereas this practice presents the virus in the absence of water as droplet nuclei.
5.6 This practice differs from Test Method E2721 because (1) smaller particles are being formed, (2) the droplets will be dried, thus forming droplet nuclei, prior to application to air-permeable materials, and (3) unique equipment is required to create the droplet nuclei.
SCOPE
1.1 This practice is designed to evaluate decontamination methods (physical, chemical, self-decontaminating materials) when used on air-permeable materials contaminated with virus-containing droplet nuclei.
1.2 This practice defines the conditions for simulating respiratory droplet nuclei produced by humans.
1.3 The practice is specific to influenza viruses, but could be adapted for work with other types of respiratory viruses or surrogates.
1.4 This practice is suitable only for air-permeable materials.
1.5 This practice does not address the performance of decontaminants against microbes expelled via blood splatter, vomit, or fecal contamination.
1.6 This practice should be performed only by those trained in bioaerosols, microbiology, or virology, or combinations thereof.
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
WITHDRAWN RATIONALE
This practice is designed to evaluate decontamination methods (physical, chemical, self-decontaminating materials) when used on air-permeable materials contaminated with virus-containing droplet nuclei.
Formerly under the jurisdiction of Committee E35 on Pesticides, Antimicrobials, and Alternative Control Agents, this practice was withdrawn in January 2023. This standard is being withdrawn without replacement due to its limited use by industry.
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SIGNIFICANCE AND USE
5.1 This test method is designed to evaluate the effectiveness of cleaning reusable medical instruments using a specified cleaning process.
5.2 This test method may be used to determine the effectiveness of cleaning processes of recesses, hinged sites, lumina, or other difficult-to-reprocess areas of reusable medical instruments.
5.3 This test method may also be used to verify the claims for any portion of the cleaning cycle.
5.4 The recovery of surviving microorganisms may be accomplished using swabbing, rinsing, or total immersion of instruments.
5.5 The efficacy of the elution methods or loss of the applied inoculum may be assessed by recovery of target organisms from control instruments that have not been subjected to the cleaning process.
SCOPE
1.1 This test method is written principally for large medical instruments or instruments with internal channels or recesses (for example, flexible endoscopes) but may be used for any resuable medical instruments.
1.2 This test method describes a procedure for testing the efficacy of a cleaning process for reusable medical instruments artificially contaminated with mixtures of microorganisms and simulated soil.
1.3 The test method utilizes bacterial spores as tracers for foreign materials and quantifies their removal as a means of determining the efficacy of a cleaning process.
1.4 The test method is designed for use by manufacturers of medical instruments and devices. However, it may also be employed by other individuals who have a knowledge of the instruments, techniques and access to appropriate facilities.
1.5 Worst-case conditions can be represented by exaggerating a specific test parameter or otherwise intentionally simulating an extreme condition such as performing the test without cleaning solutions or utilizing instruments which are not new.
1.6 The test procedure is devised to determine the efficacy of a cleaning process as applied to a particular instrument or group of instruments by simulating actual use situations.
1.7 The test procedure may be performed on test instruments using a complete cleaning cycle or be limited to particular phases of the cycle such as precleaning, manual cleaning, automated cleaning, or rinsing.
1.8 The test procedure is normally performed on a number of external and internal sites, but it may be restricted to one particular site on the instrument.
1.9 A knowledge of microbiological and aseptic techniques and familiarity with the instruments is required to conduct these procedures.
Note 1: Because contamination of the surfaces of instruments may occur as a result of rinsing with tap water, bacteria-free water should be used for all rinsing when a water rinse step is part of the cleaning directions.
Note 2: Test methods to determine the effectiveness of cleaning medical instruments has only recently been actively debated, and research efforts are in their infancy. Because published experimental results are scarce, it is premature to dictate experimental reagents, conditions or acceptance criteria.
Note 3: The total elimination of the target organisms is not the goal of cleaning. Therefore, there will almost always be a number of microorganisms surviving on the test instruments unless one of the solutions or processes disinfects or sterilizes the test instrument. The results of various clinical and laboratory tests suggest that cleaning processes alone can produce a 102 to 104 log10 reduction in bioburden. The exact reduction will depend upon the precise experimental conditions. The criteria for judging cleanliness should be determined and recorded before initiation of the test procedure.
Note 4: This test protocol employs target spores as indicators or tracers for foreign materials and monitors their removal by the cleaning process. It is certainly possible that other particulate target materials, such as microbeads (latex beads) could be used in place of microbes. T...
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ISO 11137-2:2006 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level (SAL) of 10-6. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2006 defines product families for dose establishment and dose auditing.
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SCOPE
1.1 This practice covers the flexible fiberoptic and video endoscopes that are fully immersible in liquid and are used in the examination of the hollow viscera (that is, colonoscopes, gastroscopes, duodenoscopes, and sigmoidoscopes). These endoscopes will be referred to as flexible gastrointestinal (GI) endoscopes.
1.2 This practice is intended to complement, not replace the instructions and labeling provided by product manufacturers. Endoscope manufacturers must provide instructions and labeling necessary for users to know the basic design, specifications, nomenclature, and components of specific flexible GI endoscopes and to properly inspect, prepare, use, clean, disinfect, rinse, dry, and store these instruments.
1.3 Endoscopic technique and the medical aspects of gastrointestinal endoscopy are not covered in this practice.
1.4 This practice details the steps necessary to properly reprocess flexible GI endoscopes and render them patient-ready.
1.5 A patient-ready endoscope is one that has been rendered visibly clean after being subjected to a validated cleaning procedure, subjected minimally to a high-level disinfection process, and rinsed so that it does not contain residual reprocessing chemicals in amounts which can be harmful to humans.
1.5.1 It is recognized that in some circumstances, portions of endoscopes that neither contact patients directly nor contact fluids that may contact patients probably do not have to be subjected to high-level disinfection.
1.6 This practice details manual reprocessing as well as automated reprocessing of flexible GI fiberoptic and video endoscopes.
1.7 The application of all practices relating to endoscopic reprocessing will ultimately fall into the purview of the individual assigned to that task in an endoscopic area.
1.7.1 To ensure the proper adherence to this practice, those personnel should themselves meet certain requirements as specified in 4.8.
1.8 This practice does not detail the steps necessary for the reprocessing of endoscopic accessories.
1.9 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. Specific precautionary statements are given in Notes 1 and 2.
WITHDRAWN RATIONALE
This practice covers the flexible fiberoptic and video endoscopes that are fully immersible in liquid and are used in the examination of the hollow viscera (that is, colonoscopes, gastroscopes, duodenoscopes, sigmoidoscopes, and enteroscopes). These endoscopes will be referred to as flexible gastrointestinal (GI) endoscopes.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this practice was withdrawn in January 2009 in accordance with section 10.5.3.1 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.
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