Medical Device Regulation (EU) 2017/745
Council Directive 93/42/EEC Medical Device Directive (MDD)
Directive 2014/30/EU EMC Directive (EMCD)
Directive 2014/53/EU Radio Equipment Directive (RED)
FDA 21 CFR Part 820 and Part 4.
EN/IEC 60601-1-2 EMC for medical devices
EN/IEC 60601-1 General requirements for basic safety and essential performance for medical devices
EN 60601-2-66 Particular standard for hearing aids
EN/IEC 62366 Usability Engineering for medical devices
EN ISO 14971 Risk Management for Medical Devices
EN ISO 13485 Quality Management for Medical Devices
EN 301 489-1, -3, etc. EMC for radio devices / short-range devices in the EU.
EN 300 220 radio parameter requirements for radio devices / short range devices in EU.
EN 300 330 radio parameter requirements for radio devices / short range devices in EU.
EN 300 440 radio parameter requirements for radio devices / short range devices in EU.
EN 300 328 radio parameter requirements for radio devices / short range devices in EU.
ANSI C63.4 EMC parameter requirements for radio devices / short range devices in USA.
ANSI C63.10 radio parameter requirements for radio devices / short range devices in USA.