Mobilmed’s ECG Recorder has built-in 50/60 Hz noise filtering algorithms with using sampling rate of 600Hz and it conforms to the following standards :
- 2014/53/EU RED Directive EN 301 489-1, EN 301 489-17
- 93/42/EEC Medical Directive EN 60601-1-2
- 93/42/EEC Medical Directive EN 60601-1 Safety tests
- ISO 13485:2016, Medical devices – Quality Management Systems
- ISO 10993 Biocompatibility Tests
- The product is in process of CE Certification