NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 7197 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 14630 | 2024-09 | Non-active surgical implants - General requirements More |
| ISO/TR 14283 | 2018-01 | Implants for surgery - Essential principles of safety and performance More |
| ASTM F 2052 | 2021 | Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment More |
| ASTM F 2182 | 2019 | Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging More |
| ASTM F 2213 | 2017 | Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment More |
| ASTM F 2503 | 2023 | Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment 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 62570 | 2016-09 | Standard practice for marking medical devices and other items for safety in the magnetic resonance environment (IEC 62570:2014); German version EN 62570:2015 More |
| EUV 2017/745 | 2017-04-05 | Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC More |
