This course explains the duties and responsibilities of manufacturers of lasers and any products incorporating lasers, and provide them with a working knowledge of the existing US and international regulations. The course describes the extensive changes in the latest edition 2.0 (2007) of the international laser safety standard IEC 60825-1, including the removal of LEDs from its scope, revised measurement and classification procedures, certain engineering control measures and user information requirements. A detailed review of the performance (engineering), labelling, documentation and testing requirements of the applicable standards is provided, including the revised edition 3.0 (2007) of IEC 60601-2-22 for surgical and other high power medical lasers. The course provides guidance for successful and timely completion of the certification process including the deviations granted by FDA/CDRH Laser Notice 50. It concludes with a summary of the most common failures (engineering, labeling and documentation) identified by the author during evaluation and testing of laser products.

This course will explain the duties and responsibilities of manufacturers of devices, instruments and systems incorporating lasers, and provide them with a working knowledge of existing Canadian, US and international regulations, including latest developments in the field. The course is focused on the performance (engineering), labelling, documentation and testing requirements of the applicable standards and provides guidance for successful and timely completion of the certification process including deviations granted by FDA’s conditional acceptance (2001) of conformance with IEC 60825-1:1998+A2:2001 and IEC 60601-2-22.

This course explains the duties and responsibilities of manufacturers of devices, instruments and systems incorporating lasers, and provides them with a working knowledge of existing US, Canadian and international regulations, including latest developments in this field. The course will focus on the performance (engineering), labelling, documentation and testing requirements of the applicable standards and provide guidance for successful and timely completion of the certification process including deviations granted by FDA’s conditional acceptance of conformance with IEC 60825-1:1998+A2:2001 and IEC 60601-2-22.