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DIN Standards Committee Health Technologies

DIN EN ISO 8637-2 [CURRENT] references following documents:

Document number Edition Title
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 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 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 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 20417 2022-03 Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12); German version EN ISO 20417:2021 More 
DIN EN ISO 23500-3 2024-09 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2024); German version EN ISO 23500-3:2024 More 
DIN EN ISO 23500-4 2024-09 Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2024); German version EN ISO 23500-4:2024 More 
DIN EN ISO 23500-5 2024-09 Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2024); German version EN ISO 23500-5:2024 More 
DIN EN ISO 7864 2016-12 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016); German version EN ISO 7864:2016 More 
DIN EN ISO 80369-7 2021-08 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2021); German version EN ISO 80369-7:2021 More