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NA 176

DIN Standards Committee Health Technologies

About NAGesuTech Projects Drafts Publications Documents withdrawn without replacement National committees European committees International committees

DIN EN 556-2 [New] references following documents:

Document number	Edition	Title
EN ISO 11135	2014-07	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) More
EN ISO 11137-1	2015-06	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) More
EN ISO 13408-2	2018-03	Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018) More
EN ISO 13408-5	2011-06	Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006) More
EN ISO 13485	2016-03	Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) More
EN ISO 14160	2021-06	Sterilization 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) More
EN ISO 14937	2009-10	Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) More
EN ISO 17665	2024-05	Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024) More
EN ISO 20857	2013-04	Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010) More
EN ISO 25424	2019-11	Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018) More

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