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Standards UNE - Spanish national standards - Page 144
Spanish national standards UNE are published by the company AENOR, which deals with the development of national standardization and certification in all industrial and services sectors. Its aim is to contribute to the quality, competitiveness and improvement of companies and to protect the environment.
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UNE-EN ISO 11135:2015
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Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
Standard published on 22.4.2015
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UNE-EN ISO 11135:2015/A1:2020
Change
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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)
Change published on 22.7.2020
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UNE-EN ISO 11136:2017
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Sensory analysis - Methodology - General guidance for conducting hedonic tests with consumers in a controlled area (ISO 11136:2014)
Standard published on 27.12.2017
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UNE-EN ISO 11136:2017/A1:2021
Change
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Sensory analysis - Methodology - General guidance for conducting hedonic tests with consumers in a controlled area - Amendment 1 (ISO 11136:2014/Amd 1:2020)
Change published on 24.11.2021
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UNE-EN ISO 11137-1:2015
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Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
Standard published on 16.9.2015
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UNE-EN ISO 11137-1:2015/A2:2020
Change
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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)
Change published on 22.7.2020
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UNE-EN ISO 11137-2:2015
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Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
Standard published on 16.9.2015
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UNE-EN ISO 11137-2:2015/A1:2023
Change
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Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
Change published on 12.7.2023
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UNE-EN ISO 11137-3:2018
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Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)
Standard published on 16.5.2018
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UNE-CEN ISO/TS 11137-4:2023
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Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020) (Endorsed by Asociación Espanola de Normalización in August of 2023.)
Standard published on 1.8.2023
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