NA 176
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 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 |
| DIN EN ISO 11137-2 | 2023-08 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013 + Amd 1:2022); German version EN ISO 11137-2:2015 + A1:2023 More |
