NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 10993-6 [available pre-publication] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 10993-12 | 2021-01 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials More |
| ISO 10993-1 | 2025-11 | Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process More |
| ISO 10993-16 | 2017-05 | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables More |
| ISO 10993-2 | 2022-11 | Biological evaluation of medical devices - Part 2: Animal welfare requirements More |
| ISO 10993-4 | 2017-04 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood More |
| ISO 10993-9 | 2019-11 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products More |
| ASTM F 1635 | 2024 | Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants More |
| ASTM F 1983 | 2023 | Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications More |
| ASTM F 3268 | 2026 | Standard Guide for in vitro Degradation Testing of Absorbable Metals More |
| ASTM F 748 | 2025 | Standard Practice for Selecting Biological Test Methods for Materials and Devices More |