AIMDD
EN ISO 10993-17
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
EN ISO 10993-18
Biological evaluation of medical devices - Part 18: Chemical characterization of materials
EN ISO 14155
Clinical investigation of medical devices for human subjects - Good clinical practice
EN 45502-1
Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer
EN 45502-2-1
Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
EN 45502-2-2
Active implantable medical devices -- Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
EN 45502-2-3
Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
EN 60601-1
Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
EN 60601-1-6
Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability