Synrad Novanta OEM ti Series, User Manual

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EUROPEAN UNION (EU) REQUIREMENTS PAGE | 31
Laser safety standards
Under the Low Voltage Directive, 2014/35/EC, the European Norm (EN) document EN 60825- 1:2014
was developed to provide laser safety guidance and includes clauses on Engineering Specifications,
Labeling, Other Informational Requirements, Additional Requirements for Specific Laser Products,
Classification, and Determination of the Accessible Emission Level. To develop a risk assessment
plan/laser safety program for users, see IEC/TR 60825-14:2004 that includes clauses on Administrative
Policies, Laser Radiation Hazards, Determining the MPE, Associated Hazards, Evaluating Risk, Control
Measures, Maintenance of Safe Operation, Incident Reporting and Accident Investigation, and Medical
Surveillance.
OEM models
Ti-Series OEM lasers are OEM products intended for incorporation as components in laser processing
systems. As supplied by NOVANTA®, these lasers do not meet the requirements of EN 60825-1 without
additional safeguards. European Union Directives state that “OEM laser products which are sold to other
manufacturers for use as components of any system for subsequent sale are not subject to this
Standard, since the final product will itself be subject to the Standard.” This means that Buyers of OEM
laser components are solely responsible for the assurance that the laser processing system sold to an
end-user complies with all laser safety requirements before the actual sale of the system. Note that when
an OEM laser component is incorporated into another device or system, the entire machinery installation
may be required to conform to EN 60825-1; EN 60204-1:2006, Safety of Machinery; the Machinery
Directive, EN 2006/42/EC; and/or any other applicable Standards and in cases where the system is
being imported into the U.S., it must also comply with CDRH regulations.
In cases where the Buyer is also the end-user of the OEM laser product, the Buyer/end-user must
integrate the laser so that it complies with all applicable laser safety standards as set forth above. Table
1, Class 4 safety features, summarizes Ti-Series product features, indicating the type and description of
features and whether those features are required by European Union regulations.
Electromagnetic interference standards
The European Union’s Electromagnetic Compatibility (EMC) Directive, 2004/108/EC, is the sole Directive
developed to address electromagnetic interference (EMI) issues in electronic equipment. In particular,
the Directive calls out European Norm (EN) documents that define the emission and immunity standards
for specific product categories. For ti-Series lasers, EN 61000-6-4 defines radiated and conducted RF
emission limits while EN 61000-6-2 defines immunity requirements for industrial environments.
NOVANTA ti-Series lasers have demonstrated performance characteristics that have met or exceeded
the requirements of EMC Directive 2014/30/EU.