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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About NAGesuTech Projects Drafts Publications Documents withdrawn without replacement National committees European committees International committees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 ISO 11737-1 [CURRENT] references following documents:

Document number	Edition	Title
Document number ISO 10012	Edition 2003-04	Title Measurement management systems - Requirements for measurement processes and measuring equipment More
Document number ISO 13485	Edition 2016-03	Title Medical devices - Quality management systems - Requirements for regulatory purposes More
Document number ISO/IEC 17025	Edition 2017-11	Title General requirements for the competence of testing and calibration laboratories More
Document number DIN EN ISO 10012	Edition 2004-03	Title Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003); Trilingual version EN ISO 10012:2003 More
Document number DIN EN ISO 11135	Edition 2020-04	Title 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 + Amd.1:2018); German version EN ISO 11135:2014 + A1:2019 More
Document number DIN EN ISO 11137-1	Edition 2020-04	Title 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 + Amd.2:2018); German version EN ISO 11137-1:2015 + A2:2019 More
Document number DIN EN ISO 11137-3	Edition 2017-11	Title Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017); German version EN ISO 11137-3:2017 More
Document number DIN EN ISO 11138-2	Edition 2017-07	Title Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017); German version EN ISO 11138-2:2017 More
Document number DIN EN ISO 11737-2	Edition 2020-07	Title Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019); German version EN ISO 11737-2:2020 More
Document number DIN EN ISO 14937	Edition 2010-03	Title 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); German version EN ISO 14937:2009 More

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