NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 12417-1 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 14971 | 2019-12 | Medical devices - Application of risk management 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 10993-2 | 2022-11 | Biological evaluation of medical devices - Part 2: Animal welfare requirements More |
| ISO 10993-7 | 2008-10 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals More |
| ISO 11070 | 2014-11 | Sterile single-use intravascular introducers, dilators and guidewires 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 14155 | 2020-07 | Clinical investigation of medical devices for human subjects - Good clinical practice 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 15223-1 | 2021-07 | Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements More |
| ISO 25539-2 | 2020-09 | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents More |
