Product Info

20 Chapter 2 Regulatory Information
EN 62366 / IEC 62366: Medical devices - Application of usability
engineering to 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
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
CAN/CSA-C22.2 No. 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
CAN/CSA-C22.2 No. 60601-2-18: Medical Electrical Equipment, Part 2-18:
Particular requirements for the basic safety and essential performance of
endoscopic equipment
EN 300 328: Electromagnetic compatibility and Radio Spectrum Matters
(ERM): Wideband Transmission systems; Data transmission equipment
operating in the 2.4 GHz ISM band and using wideband modulation techniques
EN 62479: Assessment of the compliance of low-power electronic and
electrical equipment with the basic restrictions related to human exposure to
electromagnetic fields (10 MHz to 300 GHz)
EN 301 489-1: Electromagnetic compatibility (EMC) standard for radio
equipment and services; Part 1: Common technical requirements
EN 301 489-17: Electromagnetic Compatibility (EMC) standard for radio
equipment and services; Part 17: Specific conditions for Broadband Data
Transmission Systems