NA 027

DIN Standards Committee Optics and Precision Mechanics

DIN EN ISO 81060-2 [CURRENT] references following documents:

Document number Edition Title
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 60601-1-11 2015-01 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment More 
IEC 60601-2-34 2011-05 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment More 
IEC 80601-2-30 2018-03 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers More 
ISO 81060-1 2007-12 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type More 
DIN EN IEC 80601-2-30 ; VDE 0750-2-30:2020-03 2020-03 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers (IEC 80601-2-30:2018); German version EN IEC 80601-2-30:2019 More 
DIN EN ISO 14155 2021-05 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020 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 81060-1 2012-08 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007); German version EN ISO 81060-1:2012 More