NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 80601-2-80 [CURRENT] references following documents:

Document number Edition Title
ISO 7396-1 2016-02 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum More 
ISO 7396-1 AMD 1 2017-12 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum; Amendment 1 More 
ISO 9360-1 2000-03 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml More 
ISO 9360-2 2001-04 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml More 
DIN EN ISO 10524-1 2024-01 Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2018 + Amd 1:2023); German version EN ISO 10524-1:2019 + A1:2023 More 
DIN EN ISO 14159 2008-07 Safety of machinery - Hygiene requirements for the design of machinery (ISO 14159:2002); German version EN ISO 14159:2008 More 
DIN EN ISO 14937 2010-03 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 (ISO 14937:2009); German version EN ISO 14937:2009 More 
DIN EN ISO 15223-1 2022-02 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021); German version EN ISO 15223-1:2021, with CD-ROM More 
DIN EN ISO 17664-1 2021-11 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 (ISO 17664-1:2021); German version EN ISO 17664-1:2021 More 
DIN EN ISO 18562-1 2025-02 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2024); German version EN ISO 18562-1:2024 More