Registration number (WIID)Project No.TitleStatus
65357LVS EN ISO 14160:2021Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020)Standarts spēkā
77012LVS EN ISO 13004:2023Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)Standarts spēkā
60762LVS EN ISO 11137-2:2015Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)Standarts spēkā
62262LVS EN ISO 11135:2014/A1:2020Sterilization 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)Standarts spēkā
65418LVS EN ISO 11137-1:2015/A2:2020Sterilization 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)Standarts spēkā
72618LVS EN ISO 17664-1:2021Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)Standarts spēkā
76989LVS EN ISO 17664-2:2024Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021)Standarts spēkā
62251EN ISO 11737-2:2020Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO/DIS 11737-2:2018)Standarts spēkā
38073EN ISO 20857:2013Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)Standarts spēkā
60761EN ISO 11137-1:2015Sterilization 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)Standarts spēkā
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