Eighteeth Helios 600 - Compliance with European and International Standards

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14 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
 ANSI/AAMI ES 60601-1: Medical Electrical Equipment - Part 1: General requirements
for basic safety and essential performanceCAN/CSA-C22.2 No. 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 80601-2-60 / IEC 80601-2-60: Medical electrical equipment — Part 2-60: Particular
requirements for the basic safety and essential performance of dental equipment
 EN 62471 / IEC 62471: Photobiological safety of lamps and lamp systems: Equipment
classification, requirements, and User’s Guide
 EN ISO 17664: Processing of health care products – Information to be provided by the
medical device manufacturer for the processing of medical devices
 EN ISO 17665-1: Sterilization of health care products — Moist heat — Part 1:
Requirements for the development, validation and routine control of a sterilization
process for medical devices
 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 62304 / IEC 62304: Medical device software - Software life cycle Processes
 EN ISO 10993: Biological evaluation of 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 ISO 9687:
Dentistry - Graphical symbols for dental equipment
 AAMI TIR 12：Designing, testing and labeling reusable medical devices for reprocessing
in health care facilities: A guide for medical device manufacturers
 AAMI TIR 30：A compendium of processes, materials, test methods, and acceptance
criteria for cleaning reusable medical devices