10 RVG 142, RVG 5200 and RVG 6200 Safety, Regulatory User Guide (SM847)
Ed06
2
Regulatory Information
General Regulatory Information
Compliance with European and International Standards
EN 60601-1/IEC 60601-1
Medical Electrical Equipment, Part 1: General requirements
for basic safety and essential performance
EN 60601-1-2/IEC 60601-1-2
Medical Electrical Equipment, Part 1-2: General
requirements for basic safety and essential performance -
Collateral Standard: Electromagnetic Disturbances –
Requirements and tests.
EN 60601-1-6/IEC 60601-1-6
Medical Electrical Equipment, Part 1-6: General
requirements for basic safety and essential performance –
Collateral Standard: Usability
EN 62366/IEC 62366
Medical devices - Application of usability engineering to
medical devices
EN ISO 14971
Medical devices - Application of risk management to medical
devices
EN ISO 15223-1
Medical devices - Symbols to be used with medical device
labels, labeling and information to be supplied - Part 1:
General requirements
EN 1041
Information supplied by the manufacturer of medical devices
EN 62304/IEC 62304
Medical device software - Software life cycle processes
EN ISO 10993-1
Biological evaluation of medical devices - Part 1: Evaluation
and testing within a risk management process
CAN/CSA C22.2 N°60601-1
Medical Electrical Equipment – Part 1: General
Requirements for basic safety and essential performance
ANSI/AAMI ES60601-1
Medical Electrical Equipment – Part 1: General
Requirements for basic safety and essential performance
