NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 3826-1 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 10993-16 | 2017-05 | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables More |
| ISO 10993-18 | 2020-01 | Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process 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 10993-3 | 2014-10 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity More |
| ISO 10993-9 | 2019-11 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products 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 3826-2 | 2008-08 | Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets More |
| ISO 3826-3 | 2006-09 | Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features More |
