NA 022
DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 62366 ; VDE 0750-241:2008-09 [Withdrawn] referenced in following documents:
| Document number | Edition | Title |
|---|---|---|
| VDE-AR-E 2750-200 | 2013-03 | Approach to the classification of medical devices and the selection of conformity assessment procedures More |
| VDE-AR-M 3756-1 | 2009-10 | Quality management for Telemonitoring for medical applications More |
| DIN EN ISO 15197 | 2015-12 | In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013); German version EN ISO 15197:2015 More |
| DIN EN ISO 18113-3 | 2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009); German version EN ISO 18113-3:2011 More |
| DIN EN ISO 18113-5 | 2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009); German version EN ISO 18113-5:2011 More |
| DIN EN ISO 20072 | 2013-10 | Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009); German version EN ISO 20072:2013 More |
| DIN EN ISO 23908 | 2013-10 | Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011); German version EN ISO 23908:2013 More |
| DIN EN ISO 80601-2-61 | 2019-09 | Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2017, Corrected version 2018-02); German version EN ISO 80601-2-61:2019 More |
| DIN EN 45502-1 ; VDE 0750-10:2016-02 | 2016-02 | Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer; German version EN 45502-1:2015 More |
| DIN IEC/TR 80001-2-5 ; VDE 0756-2-5:2016-03 | 2016-03 | Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems (IEC/TR 80001-2-5:2014) More |
