Rockwell Laser Industries has performed many compliance audits of client products destined for global markets. The IEC 825-1 is used as the base standard. This standard is currently identical to the EN 60825-1 used in Europe. RLI assists U.S. manufacturers to prepare for global marketing by interpreting the requirements of IEC 825-1 as they apply to the client's product. RLI has also provided the language translations, in several languages, for the required labels. RLI staff members serve as U.S. members on the IEC TC76 Working Group 8 and ISO/TC 172/SC 9 technical committees. The consulting services described above for IEC 825 will be extended to include the soon to be published ISO 11553 "Safety of Machinery - Laser Processing Machines, Safety Requirements." This standard was developed as a joint CEN TC 123 and ISO TC 172 SC 9 project under the ISO Working Group 3 organization. The European version will be mandatory under the EU's machinery directive.
International Testing and CE Marking
RLI is a qualified subcontract laboratory under the conformity assessment system of a major international testing organization. Recognition has been granted for all test parameters and/or system requirements for laser product safety standards, including US 21 CFR (J) Part 1040.10 and 1040.11; IEC 825-2; EN 60825-1; and EN 60825-1. With this recognition, RLI is in a position to do required testing and generation of test reports leading to CE marking or CB certification.
On-Site Tutorial On Standards Compliance
RLI has on many occasions provided a one day tutorial session on understanding the requirements of the FDA/CDRH Federal Laser Product Performance Standard, and the general requirements of 21 CFR Subchapter J, including the reporting and record keeping requirements for manufacturers. The tutorial typically uses two to three hours for presentation of overheads and discussion of reporting forms, followed by an open discussion. The remainder of the time is used to review any current product under development or build, and discussions with designers on concepts for providing Class 1 enclosures, particularly on the requirements for protective housings and interlocks. The tutorial additionally or separately addresses the requirements for IEC 825-1/EN 60825-1.
For more information regarding International Consulting Services, please contact us via email or call a consulting representative at (800) 94-LASER.