NA 022
DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN IEC 80601-2-77 ; VDE 0750-2-77:2024-09 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| DIN EN ISO 10993-18 | 2023-11 | Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020 + Amd 1:2022); German version EN ISO 10993-18:2020 + A1:2023 More |
| DIN EN ISO 10993-2 | 2023-02 | Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022); German version EN ISO 10993-2:2022 More |
| DIN EN ISO 10993-3 | 2015-02 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014); German version EN ISO 10993-3:2014 More |
| DIN EN ISO 10993-5 | 2009-10 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009 More |
| DIN EN ISO 10993-6 | 2017-09 | Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016); German version EN ISO 10993-6:2016 More |
| DIN EN ISO 10993-7 | 2022-09 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009 + Amd 1:2019); German version EN ISO 10993-7:2008 + AC:2009 + A1:2022 More |
| DIN EN ISO 10993-9 | 2022-03 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019); German version EN ISO 10993-9:2021 More |
| DIN EN ISO 13482 | 2014-11 | Robots and robotic devices - Safety requirements for personal care robots (ISO 13482:2014); German version EN ISO 13482:2014 More |
| DIN EN ISO 17664-1 | 2021-11 | Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021); German version EN ISO 17664-1:2021 More |
| DIN EN 60601-1 ; VDE 0750-1:2022-11 | 2022-11 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 + Cor1:2006 + Cor2:2007 + A1:2012 + A1:2012/Cor1:2014 + A2:2020); German version EN 60601-1:2006 + Cor.:2010 + A1:2013 + AC:2014 + A1:2013/AC:2014 + A12:2014 + A2:2021 More |
