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DIN Standards Committee Health Technologies

DIN EN ISO 11608-1 [CURRENT] references following documents:

Document number Edition Title
DIN EN ISO 11608-7 2017-10 Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016); German version EN ISO 11608-7:2017 More 
DIN EN ISO 13485 2021-12 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021 More 
DIN EN ISO 14253-1 2018-07 Geometrical product specifications (GPS) - Inspection by measurement of workpieces and measuring equipment - Part 1: Decision rules for verifying conformity or nonconformity with specifications (ISO 14253-1:2017); German version EN ISO 14253-1:2017 More 
DIN EN ISO 14971 2022-04 Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021 More 
DIN EN ISO 9001 2015-11 Quality management systems - Requirements (ISO 9001:2015); German and English version EN ISO 9001:2015 More 
DIN EN ISO/IEC 17025 2018-03 General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2017); German and English version EN ISO/IEC 17025:2017 More 
DIN EN 60068-2-30 2006-06 Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle) (IEC 60068-2-30:2005); German version EN 60068-2-30:2005 More 
DIN EN 60068-2-6 ; VDE 0468-2-6:2008-10 2008-10 Environmental testing - Part 2-6: Tests - Test Fc: Vibration (sinusoidal) (IEC 60068-2-6:2007); German version EN 60068-2-6:2008 More 
DIN EN 60529 ; VDE 0470-1:2014-09 2014-09 Degrees of protection provided by enclosures (IP Code) (IEC 60529:1989 + A1:1999 + A2:2013); German version EN 60529:1991 + A1:2000 + A2:2013 More 
DIN EN 60601-1-10 ; VDE 0750-1-10:2021-11 2021-11 Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers (IEC 60601-1-10:2007 + A1:2013 + A2:2020); German version EN 60601-1-10:2008 + A1:2015 + A2:2021 More