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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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€21.00
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€21.00
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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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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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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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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
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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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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
Learn More€118.80