NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 80601-2-79 [Pre-order] references following documents:

Document number Edition Title
IEC Guide 115 2023-04 Application of measurement uncertainty to conformity assessment activities in the electrotechnical sector 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 2 2020-08 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; Amendment 2 More 
IEC 61672-1 2013-09 Electroacoustics - Sound level meters - Part 1: Specifications More 
IEC 62366-1 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices More 
IEC 62366-1 AMD 1 2020-06 Medical devices - Part 1: Application of usability engineering to medical devices; Amendment 1 More 
IEC 62570 2014-02 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment More 
ISO 14937 2009-10 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 More 
ISO 17664-1 2021-07 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices More