11.080 : Sterilization and disinfection

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  • NF EN ISO 11139/A1, S98-131/A1 (01/2024)

    Stérilisation des produits de santé - Vocabulaire des termes utilisés dans les normes de procédés de stérilisation et les équipements connexes - Amendement 1 : termes et définitions modifiés et supplémentaires
    1/1/2024 - Paper - French - AFNOR
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    €75.67

  • NF EN ISO 11607-2/A1, S98-052-2/A1 (10/2023)

    Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2 : exigences de validation pour les procédés de formage, scellage et assemblage - Amendement 1 : application de la gestion des risques
    10/1/2023 - Paper - French - AFNOR
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    €43.50

  • NF EN ISO 11607-1/A1, S98-052-1/A1 (10/2023)

    Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1 : exigences relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage - Amendement 1 : application de la gestion des risques
    10/1/2023 - Paper - French - AFNOR
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    €68.50

  • UNE-CEN ISO/TS 11137-4:2023

    Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020) (Endorsed by Asociación Española de Normalización in August of 2023.)
    8/2/2023 - PDF - English - AENOR
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    €95.00

  • UNE-EN ISO 11137-2:2015/A1:2023

    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
    7/12/2023 - PDF - Spanish - AENOR
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    €57.00

  • UNE-EN ISO 11137-2:2015/A1:2023

    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
    7/12/2023 - PDF - English - AENOR
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    €68.40

  • NF EN ISO 11137-2/A1, S98-103-2/A1 (04/2023)

    Sterilization of health care products - Radiation - Part 2 : Establishing the sterilization dose - Amendment 1
    4/1/2023 - Paper - French - AFNOR
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    €31.00

  • UNE-EN ISO 25424:2020/A1:2022

    Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)
    12/21/2022 - PDF - Spanish - AENOR
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    €58.00

  • UNE-EN ISO 25424:2020/A1:2022

    Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)
    12/21/2022 - PDF - English - AENOR
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    €69.60

  • UNE-EN ISO 11607-1:2020/A11:2022

    Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
    12/21/2022 - PDF - Spanish - AENOR
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    €57.00

  • UNE-EN ISO 11607-1:2020/A11:2022

    Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
    12/21/2022 - PDF - English - AENOR
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    €68.40

  • UNE-EN ISO 11607-2:2020/A11:2022

    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
    12/21/2022 - PDF - Spanish - AENOR
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    €57.00

  • UNE-EN ISO 11607-2:2020/A11:2022

    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
    12/21/2022 - PDF - English - AENOR
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    €68.40

  • UNE-CEN/TR 17825:2022

    Chemical disinfectants and antiseptics - Interpretation of water controls in EN 16615:2015 (Endorsed by Asociación Española de Normalización in October of 2022.)
    10/12/2022 - PDF - English - AENOR
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    €28.00

  • NF EN ISO 11607-1/A11, S98-052-1/A11 (06/2022)

    Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1 : exigences relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage - Amendement A11
    6/1/2022 - Paper - French - AFNOR
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    €48.00

  • NF EN ISO 11607-2/A11, S98-052-2/A11 (06/2022)

    Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2 : exigences de validation pour les procédés de formage, scellage et assemblage - Amendement A11
    6/1/2022 - Paper - French - AFNOR
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    €48.00

  • NF EN ISO 25424/A1, S98-008/A1 (05/2022)

    Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1
    5/1/2022 - Paper - French - AFNOR
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    €34.67

  • UNE-EN ISO 11737-1:2018/A1:2022

    Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)
    2/16/2022 - PDF - Spanish - AENOR
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    €58.00

  • UNE-EN ISO 11737-1:2018/A1:2022

    Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)
    2/16/2022 - PDF - English - AENOR
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    €69.60

  • NF EN ISO 10993-7/A1, S99-501-7/A1 (01/2022)

    Biological evaluation of medical devices - Part 7 : Ethylene oxide sterilization residuals - Amendment 1
    1/1/2022 - Paper - French - AFNOR
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    €43.50

  • UNE-CEN ISO/TS 16775:2021

    Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021) (Endorsed by Asociación Española de Normalización in January of 2022.)
    1/1/2022 - PDF - English - AENOR
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    €171.00

  • NF EN ISO 11737-1/A1, S98-118-1/A1 (06/2021)

    Sterilization of health care products - Microbiological methods - Part 1 : determination of a population of microorganisms on products - Amendment 1
    6/1/2021 - Paper - French - AFNOR
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    €25.67

  • UNE-EN ISO 11135:2015/A1:2020

    Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
    7/22/2020 - PDF - Spanish - AENOR
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    €68.00

  • UNE-EN ISO 11135:2015/A1:2020

    Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
    7/22/2020 - PDF - English - AENOR
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    €81.60

  • UNE-EN ISO 11137-1:2015/A2:2020

    Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
    7/22/2020 - PDF - Spanish - AENOR
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    €68.00

  • UNE-EN ISO 11137-1:2015/A2:2020

    Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
    7/22/2020 - PDF - English - AENOR
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    €81.60

  • UNE-EN ISO 28258:2013/A1:2019

    Soil quality - Digital exchange of soil-related data - Amendment 1 (ISO 28258:2013/Amd 1:2019) (Endorsed by Asociación Española de Normalización in December of 2019.)
    12/1/2019 - PDF - English - AENOR
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    €75.00

  • NF EN ISO 11135/A1, S98-101/A1 (11/2019)

    Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - AMENDMENT 1 : Revision of Annex E, Single batch release - Stérilisation des produits de santé - Oxyde d'éthylène - Exigences de développement, de validation et de contrôle de routine d'un processus de stérilisation pour des dispositifs médicaux - Amendement 1
    11/1/2019 - Paper - French - AFNOR
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    €34.67

  • NF EN ISO 11137-1/A2, S98-103-1/A2 (11/2019)

    Sterilization of health care products - Radiation - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2 : Revision to 4.3.4 and 11.2 - Stérilisation des produits de santé - Irradiation - Partie 1 : exigences relatives à la mise au point, à la validation et au contrôle de routine d'un procédé de stérilisation pour les dispositifs médicaux - Amendement 2
    11/1/2019 - Paper - French - AFNOR
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    €25.67

  • UNE-CEN/TR 17296:2018

    Chemical disinfectants and antiseptics - Differentiation of active and non-active substances (Endorsed by Asociación Española de Normalización in January of 2019.)
    1/1/2019 - PDF - English - AENOR
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    €24.00

  • ISO 11137-1:2006/Amd 2:2018

    Sterilization of health care products
    Radiation
    11/8/2018 - Paper - French - ISO
    Learn More
    €21.00

  • ISO 11135:2014/Amd 1:2018

    Sterilization of health-care products
    Ethylene oxide
    10/15/2018 - Paper - French - ISO
    Learn More
    €21.00

  • UNE-EN ISO 15883-1:2009/A1:2014

    Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006/Amd 1:2014)
    12/23/2014 - PDF - Spanish - AENOR
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    €58.00

  • UNE-EN ISO 15883-1:2009/A1:2014

    Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006/Amd 1:2014)
    12/23/2014 - PDF - English - AENOR
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    €69.60

  • NF EN ISO 15883-1/A1, S98-040-1/A1 (08/2014)

    Washer-disinfectors - Part 1 : general requirements, terms and definitions and tests
    8/1/2014 - Paper - French - AFNOR
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    €25.67

  • ISO 15883-1:2006/Amd 1:2014

    Washer-disinfectors
    Part 1: General requirements, terms and definitions and tests
    6/25/2014 - Paper - French - ISO
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    €21.00

  • ISO 11137-1:2006/Amd 1:2013

    Sterilization of health care products
    Radiation
    7/16/2013 - Paper - French - ISO
    Learn More
    €21.00

  • UNE-CEN ISO/TS 17665-2:2009 EX

    Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009)
    10/28/2009 - PDF - Spanish - AENOR
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    €99.00

  • UNE-CEN ISO/TS 17665-2:2009 EX

    Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009)
    10/28/2009 - PDF - English - AENOR
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    €118.80

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