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    • Standard
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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 (...view more

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    • Standard
      25 pages
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    • Standard
      27 pages
      French language
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      36 pages
      English language

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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    • Technical specification
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      13 pages
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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 s...view more

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    • Standard
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    • Standard
      26 pages
      French language
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      24 pages
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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 requiremen...view more

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    • Technical specification
      46 pages
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    • Technical specification
      48 pages
      French language
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      46 pages
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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 micro...view more

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    • Standard
      37 pages
      English language
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    • Standard
      37 pages
      English language
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    • Standard
      41 pages
      French language
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    • Standard
      41 pages
      French language

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 ...view more

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    • Technical specification
      17 pages
      English language
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      18 pages
      French language
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      17 pages
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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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    • Technical specification
      55 pages
      English language
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    • Technical specification
      55 pages
      English language

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, ...view more

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    • Standard
      35 pages
      English language
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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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    • Amendment
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    • Amendment
      7 pages
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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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    • Amendment
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    • Amendment
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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...view more

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    • Standard
      63 pages
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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 pr...view more

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    • Standard
      16 pages
      English language
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    • Standard
      18 pages
      French language

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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    • Amendment
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    • Amendment
      7 pages
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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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    • Amendment
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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 equipmen...
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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 exchan...view more

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    • Amendment
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    • Amendment
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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 th...
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    • Standard
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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 se...
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    • Standard
      73 pages
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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 selec...view more

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    • Standard
      64 pages
      English language
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    • Standard
      69 pages
      French language

This International Standard defines terms in the field of sterilization of healthcare products used in the standards developed by ISO/TC 198 "Sterilization of healthcare products", CEN/TC 204 "Sterilization of medical devices", and CEN/TC 102 "Sterilizers and associated equipment for processing of medical devices".

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    • Standard
      56 pages
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This document specifies the requirements for test equipment to be used to:
— test biological indicators for steam, ethylene oxide gas and dry heat sterilization processes for
conformity to the requirements given in ISO 11138 series;
— test chemical indicators for steam, ethylene oxide gas, dry heat and vaporized hydrogen peroxide
sterilization processes for conformity to the requirements given in ISO 11140-1:2014.
This document also provides informative methods useful in characterizing the ...
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    • Standard
      1 page
      English language
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    • Standard
      1 page
      French language

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....view more

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    • Standard
      41 pages
      English language
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    • Standard
      44 pages
      French language
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    • Standard
      4 pages
      English language
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    • Standard
      4 pages
      French language

This document specifies the requirements for test equipment to be used to:
— test biological indicators for steam, ethylene oxide gas and dry heat sterilization processes for conformity to the requirements given in ISO 11138 series;
— test chemical indicators for steam, ethylene oxide gas, dry heat and vaporized hydrogen peroxide sterilization processes for conformity to the requirements given in ISO 11140‑1:2014.
This document also provides informative methods useful in characterizing the pe...
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    • Standard
      39 pages
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This document defines terms in the field of the sterilization of health care products including related equipment and processes.

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    • Standard
      56 pages
      English language
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This document specifies the requirements for test equipment to be used to: — test biological indicators for steam, ethylene oxide gas and dry heat sterilization processes for conformity to the requirements given in ISO 11138 series; — test chemical indicators for steam, ethylene oxide gas, dry heat and vaporized hydrogen peroxide sterilization processes for conformity to the requirements given in ISO 11140‑1:2014. This document also provides informative methods useful in characterizing the perfo...view more

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    • Standard
      31 pages
      English language
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    • Standard
      32 pages
      French language

This document defines terms in the field of the sterilization of health care products including related equipment and processes.

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    • Standard
      48 pages
      English language
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    • Standard
      50 pages
      French language

This document specifies requirements for sterilizing filtration as part of aseptic processing of health
care products conducted in accordance with ISO 13408-1. It also offers guidance to filter users
concerning general requirements for set-up, validation and routine operation of a sterilizing filtration
process.
This document is not applicable to removal of viruses.
Sterilizing filtration is not applicable to fluids that intentionally contain particles larger than the pore
size of the filt...
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ISO/TR 20520:2018 specifies aspects to be considered for infection control for acupuncture treatment. Clinical practice in acupuncture treatment is outside the scope of this document.

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    • Technical report
      5 pages
      English language

ISO 13408-2:2018 specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408‑1. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process.
ISO 13408-2:2018 is not applicable to removal of viruses.
Sterilizing filtration is not applicable to fluids that intentionally contain particles larger than the pore size of the fi...
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This document specifies requirements and provides guidance on the enumeration and microbial
characterization of the population of viable microorganisms on or in a health care product, component,
raw material or package.
NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data.
NOTE 2 See Annex A for guidance on Clauses 1 to 9.
This document does not apply to the enumeration or identification of viral, prion or protozoan
contaminants. Thi...
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ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package.
NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data.
NOTE 2 See Annex A for guidance on Clauses 1 to 9.
ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. ...
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ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package. NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data. NOTE 2 See Annex A for guidance on Clauses 1 to 9. ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. Thi...view more

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    • Standard
      48 pages
      English language
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    • Standard
      54 pages
      French language

This document specifies requirements for the information to be provided by the medical device
manufacturer for the processing of a medical device that requires cleaning followed by disinfection
and/or sterilization to ensure that the device is safe and effective for its intended use.
This includes information for processing prior to use or reuse of the medical device. The provisions
of this document are applicable to medical devices that are intended for invasive or other direct or
indirect...
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    • Standard
      33 pages
      English language
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ISO 13408-2:2018 specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408‑1. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process. ISO 13408-2:2018 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids that intentionally contain particles larger than the pore size of the filt...view more

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    • Standard
      34 pages
      English language
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    • Standard
      35 pages
      French language

ISO 17664:2017 specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective for its intended use.
This includes information for processing prior to use or reuse of the medical device. The provisions of ISO 17664:2017 are applicable to medical devices that are intended for invasive or other direct or indirect p...
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    • Standard
      33 pages
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ISO/TS 19930:2017 provides guidance on identifying the aspects to be considered as part of a risk-based approach to selecting a sterility assurance level (SAL) for terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a SAL of 10−6. In addition, this document provides a) background information on the assurance of sterility and sterility assurance level, and b) guidance on strategies that can allow the achievement of a maximal SAL of 10−...view more

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    • Technical specification
      23 pages
      English language
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    • Technical specification
      26 pages
      French language

ISO 17664:2017 specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective for its intended use. This includes information for processing prior to use or reuse of the medical device. The provisions of ISO 17664:2017 are applicable to medical devices that are intended for invasive or other direct or indirect pa...view more

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    • Standard
      24 pages
      English language
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    • Standard
      24 pages
      French language

This document 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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    • Standard
      50 pages
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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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    • Standard
      50 pages
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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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    • Standard
      41 pages
      English language
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    • Standard
      45 pages
      French language

This document specifies requirements for test organisms, suspensions, inoculated carriers, biological
indicators and test methods intended for use in assessing the performance of sterilization processes
employing moist heat as the sterilizing agent.
NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by the
ISO 17665 series.
NOTE 2 National or regional regulations can provide requirements for work place safety.

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    • Standard
      16 pages
      English language
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This document specifies requirements for test organisms, suspensions, inoculated carriers, biological
indicators and test methods intended for use in assessing the performance of sterilization processes
employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C.
NOTE 1 Requirements for validation and control of dry heat sterilization processes are provided by ISO 20857.
NOTE 2 Requirements for work place safety can be provided by national or ...
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    • Standard
      16 pages
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This document specifies general requirements for production, labelling, test methods and performance
characteristics of biological indicators, including inoculated carriers and suspensions, and their
components, to be used in the validation and routine monitoring of sterilization processes.
This document specifies basic and common requirements that are applicable to all parts of ISO 11138.
Requirements for biological indicators for particular specified processes are provided in the relevant
...
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    • Standard
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ISO 11138-2:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.
NOTE 1 Requirements for validation and control of ethylene oxide sterilization p...
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    • Standard
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This document specifies requirements for test organisms, suspensions, inoculated carriers, biological
indicators and test methods intended for use in assessing the performance of sterilization processes
employing low-temperature steam and formaldehyde as the sterilizing agent.
NOTE 1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization
processes are provided by ISO 14937.
NOTE 2 Requirements for work place safety can be provided by national or regi...
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2016-12-13: Decision 458 on de-harmonization of EN ISO 11138 series taken on 2016-12-09.

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ISO 11138-1:2017 specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.
ISO 11138-1:2017 specifies basic and common requirements that are applicable to all parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the releva...
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