1.4. COMPLIANCE WITH REGULATION AND LAW
The Laser System is subject to several United States and European Union (EU) directives. These
directives impose product performance requirements related to electromagnetic compatibility (EMC) and
product safety features for laser products. The associated directives and specific provisions to which the
laser marking system must comply are identified and described in the following paragraphs
1.4.1. CDRH REQUIREMENTS
HITACHI laser marking system is designed to comply with requirements for Class IV laser products
imposed by the Radiation Control for Health and Safety Act of 1968. Under this act, the U.S Food and
Drug Administration (FDA) issued a performance standard in the Code of Federal Regulations (CFR) for
laser products. This performance standard (21 CFR, Part 1040.10) was developed to protect public
health and safety by imposing requirements upon manufacturers of laser products to provide an
indication of the presence of laser radiation, to provide the user with certain means to control radiation,
and to assure that all personnel are adequately warned of potential hazards through the use of product
labels and instructions.
Federal regulation require that all laser products manufactured on or after August 2, 1976 must be
certified as complying with the performance standard. The manufacturer must demonstrate the product’s
compliance with the standard prior to certification or introduction of the product in the market by filing
reports pertaining to the radiation safety of the product and the associated quality control program to the
Centre for Devices and Radiological Health (CDRH). Failure to provide the required reports or product
certification is a violation of Section 360B of the Radiation Control and Health and Safety Service Act of
1968.
Product features included in the design of the laser marking system to comply with CDRH requirements
are built into the system as control panels or indicators, internal circuit elements, or input/output signal
interfaces. Specifically, these features include a key switch, Laser and Ready indicators, emergency stop
button, remote interlock and five-seconds delay between POWER-ON (Ready indicator) and operation of
laser. Table 1 summarizes the laser marking system product features, indicating type and description,
and which features are required by CDRH regulations.
Common safe operating practices should be exercised at all times
when the laser is in use. To prevent exposure to direct or diffused laser
radiation, follow all safety precautions specified in this instruction
manual. The use of controls or adjustments or performance of
procedures other than those specified herein may result in exposure to
hazardous invisible laser radiation, damage to, or malfunction of the
laser. Severe burns may result from direct exposure to the laser beam.
Always wear safety goggles with side shields to reduce the risk of
damage to the eyes when operating the laser.
1-9 •COMPLIANCE WITH REGULATION AND LAW
