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REFERENCE STANDARDS
The following reference standards were applied in design, production, and testing of the product:
EU Directives
•
DIRECTIVE 93/42/EEC “MEDICAL DEVICES ” of 14 June 1993.
•
DIRECTIVE 2002/96/EC “Waste Electrical and Electronic Equipment (WEEE).”
Standards concerning Quality Management Systems
•
UNI EN ISO 9001:2000 “Quality Management Systems – Requirements.”
•
UNI EN ISO 13485:2004 “Medical Devices – Quality Management Systems - Clinical Requirements for
Regulatory Compliance.”
Technical Standards
•
EN 60601-1 - “MEDICAL ELECTRICAL EQUIPMENT – PART 1: GENERAL REQUIREMENTS FOR SAFETY" as
amended, corresponding to Italian standard CEI 62-5 - 2005 edition.
•
EN 60601-1-2 - “MEDICAL ELECTRICAL EQUIPMENT – PART 2: Collateral Standard: Electromagnetic
Compatibility,” corresponding to Italian standard CEI 62-50 – 2001 edition.
•
UNI EN ISO 8596 (1996) “Visual Acuity Test Types. Standard Optotype and its Presentation.”
•
UNI EN ISO 8597 (1996) “Visual Acuity Test Types. Method for Correlating Optotypes.”
•
ISO 10938: (1998) “Ophthalmic instruments. Chart Projectors”
•
UNI EN ISO 15004 “Ophthalmic instruments. Fundamental Requirements and Test Methods.” 2000 edition.
•
UNI EN ISO 14971:2004 “Risk Management for Medical Devices.”
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