NA 176

DIN Standards Committee Health Technologies

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

Document number Edition Title
DIN EN 60601-1-8 ; VDE 0750-1-8:2021-12 2021-12 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (IEC 60601-1-8:2006 + A1:2012 + A2:2020); German Version EN 60601-1-8:2007 + Cor.:2010 + A1:2013 + A1:2013/AC:2014 + A11:2017 + A2:2021 More 
DIN EN 60601-1-9 ; VDE 0750-1-9:2021-05 2021-05 Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design (IEC 60601-1-9:2007 + A1:2013 + A2:2020); German version EN 60601-1-9:2008 + A1:2013 + A2:2020 More 
DIN EN 60601-2-24 ; VDE 0750-2-24:2016-04 2016-04 Medical electrical equipment - Part 2-24: Particular requirements for basic safety and essential performance of infusion pumps and controllers (IEC 60601-2-24:2012); German version EN 60601-2-24:2015 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 
DIN ISO 11040-8 2020-11 Prefilled syringes - Part 8: Requirements and test methods for finished prefilled syringes (ISO 11040-8:2016) 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 60601-1 AMD 1 2012-07 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; Amendment 1 More 
IEC 60601-1 AMD 1 Corrigendum 1 2014-07 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; Amendment 1, Corrigendum 1 More 
IEC 60601-1 AMD 1 Interpretation Sheet 1 ; IEC 60601 AMD 1/ISH1:2021-03 2021-03 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; Amendment 1; Interpretation Sheet 1 More