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DIN Standards Committee Health Technologies

DIN EN ISO 21649 [CURRENT] references following documents:

Document number Edition Title
DIN EN 61000-4-2 ; VDE 0847-4-2:2009-12 2009-12 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test (IEC 61000-4-2:2008); German version EN 61000-4-2:2009 More 
DIN EN 61672-1 2014-07 Electroacoustics - Sound level meters - Part 1: Specifications (IEC 61672-1:2013); German version EN 61672-1:2013 More 
DIN EN 62366-1 ; VDE 0750-241-1:2021-08 2021-08 Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + COR1:2016 + A1:2020); German version EN 62366-1:2015 + AC:2015 + A1:2020 More 
IEC 60068-2-30 2005-08 Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle) More 
IEC 60601-1 2005-12 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance More 
IEC/TR 60601-4-1 2017-05 Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy More 
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 More 
ISO 11137-2 2013-06 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose More 
ISO 11137-2 AMD 1 2022-06 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose; Amendment 1 More 
ISO 11137-3 2017-06 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control More