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DIN Standards Committee Health Technologies

DIN EN ISO 10555-1 [CURRENT] references following documents:

Document number Edition Title
IEC 62366-1 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices More 
ISO 10993-1 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process More 
ISO 11607-1 2019-02 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems More 
ISO 14971 2019-12 Medical devices - Application of risk management to medical devices More 
ISO 15223-1 2021-07 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements More 
ISO 7886-1 2017-05 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use More 
ISO 80369-7 2021-05 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications More 
ASTM F 640 2023 Standard Test Methods for Determining Radiopacity for Medical Use More 
DIN EN ISO 10993-1 2021-05 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020 More 
DIN EN ISO 11137-1 2020-04 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd.1:2013 + Amd.2:2018); German version EN ISO 11137-1:2015 + A2:2019 More