NA 022
DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 50637 ; VDE 0750-212:2018-07 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| IEC 60601-1-2 | 2014-02 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests More |
| IEC 60601-1-3 | 2008-01 | Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral standard: Radiation protection in diagnostic X-ray equipment More |
| EN ISO 10993-13 | 2010-06 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010) More |
| EN ISO 10993-14 | 2009-04 | Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001) More |
| EN ISO 10993-3 | 2014-10 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014) More |
| EN ISO 10993-4 | 2017-10 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) More |
| EN ISO 10993-5 | 2009-06 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) More |
| EN ISO 10993-6 | 2016-12 | Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016) More |
| EN ISO 10993-7 | 2008-10 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008) More |
| EN ISO 10993-7/AC | 2009-11 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009) More |
