NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 10993-18 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 10993-15 | 2019-11 | Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys More |
| ISO 10993-2 | 2022-11 | Biological evaluation of medical devices - Part 2: Animal welfare requirements More |
| ISO 10993-9 | 2019-11 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products More |
| ISO 22442-1 | 2020-09 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management More |
| ISO 22442-2 | 2020-09 | Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling More |
| ISO 22442-3 | 2007-12 | Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents More |
| ISO 5725-1 | 2023-07 | Accuracy (trueness and precision) of measurement methods and results - Part 1: General principles and definitions More |
| ISO/TR 10993-22 | 2017-07 | Biological evaluation of medical devices - Part 22: Guidance on nanomaterials More |
| ISO/TS 10993-19 | 2020-03 | Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials More |
| ISO/TS 21726 | 2019-02 | Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents More |
