NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 10993-12 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 10993-13 | 2010-06 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices More |
| ISO 10993-14 | 2001-11 | Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics More |
| ISO 10993-15 | 2019-11 | Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys More |
| ISO 10993-16 | 2017-05 | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables More |
| ISO 10993-17 | 2023-09 | Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents More |
| ISO 10993-17 AMD 1 | 2025-11 | Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1 More |
| ISO 10993-18 AMD 1 | 2022-05 | Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor More |
| ISO 10993-2 | 2022-11 | Biological evaluation of medical devices - Part 2: Animal welfare requirements More |
| ISO 10993-23 | 2021-01 | Biological evaluation of medical devices - Part 23: Tests for irritation More |
| ISO 10993-23 AMD 1 | 2025-05 | Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1: Additional in vitro reconstructed human epidermis models More |
