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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 10993-2 | 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 10993-5 | 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 10993-7 | 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 |
| DIN EN 60601-1-11 ; VDE 0750-1-11:2021-12 | 2021-12 | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 + A1:2020); German version EN 60601-1-11:2015 + A1:2021 More |
| DIN EN 60601-1-2 ; VDE 0750-1-2:2022-01 | 2022-01 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014 + A1:2020); German version EN 60601-1-2:2015 + A1:2021 More |
| DIN EN 60601-1-3 ; VDE 0750-1-3:2021-10 | 2021-10 | Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment (IEC 60601-1-3:2008 + A1:2013 + A2:2021); German version EN 60601-1-3:2008 + Cor.:2010 + A1:2013 + A1:2013/AC:2014 + A11:2016 + A2:2021 More |
