Hardware device certifications
CE
FCC
IEC 60950-1 - Information technology equipment – Safety – Part 1: General requirements
FCC Part 18 - regulate industrial, scientific, and medical equipment (ISM) that emits electromagnetic energy on frequencies within the radio frequency spectrum in order to prevent harmful interference to authorized radio communication services.
IEC 62368-1 - Audio/video, information and communication technology equipment - Part 1: Safety requirements
Medical device certifications
IEC 60601-1 - Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 - Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests
Safety requirements
IEC 61010-1:2010/AMD1:2016/COR1:2019 - Corrigendum 1 - Amendment 1 - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
IEC 61010-2-101:2018 - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
Software certifications
IEC 62304 – medical device software – software life cycle processes
Quality Management System
ISO 13485 - Medical devices — Quality management systems — Requirements for regulatory purposes
Risk Management
ISO 14971 - Medical devices — Application of risk management to medical devices
