Product Manual

34
COMPLIANCE
Statement of Compliance:
EyeTech Digital Systems, Inc. declares that this equipment is in compliance with and is built to the
standards called out in EU directive 2002/95/EC.
Applicable Directives
EyeTech Digital Systems, Inc. declares that this equipment is in conformity with the provisions of Council
EMC Directive, 2004/108/EEC.
Directives and Standards:
ANSI/IEC 60529-2004
Degrees of Protection Provided by Enclosures (IP Code)
ISO 14971:2019
Medical Devices - Application of risk management to medical devices
EN 60601-1:2006/A1:2013
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 60601-1-2:2015
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential
performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 61000-3-3:2013
Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage changes, voltage
fluctuations and flicker in public low-voltage supply systems, for equipment with rated current <= 16 A
per phase and not subject to conditional connection
IEC 62304:2006
Medical device software -- Software life cycle processes