UNE - Spanish national standards

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)

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Sensory analysis - Methodology - General guidance for conducting hedonic tests with consumers in a controlled area (ISO 11136:2014)

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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)

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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)

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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)

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Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

Available languages: English, Spanish

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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)

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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)

Available languages: English, Spanish

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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.)

Available languages: English

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Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)

Available languages: English, Spanish

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