Yes, I think it's an appropriate question for this forum. We've followed the CDRH requirements for our products containing class IV lasers. But now that you raise the question we've not followed the CDRH requirements for our products that contain only Class I and II lasers and after a quick scan of 21 CFR 1040.10 it appears we should be.
-Dave From: Lauren Crane [mailto:[email protected]] Sent: Monday, October 08, 2018 11:49 AM To: [email protected] Subject: [PSES] Does incorporated barcode scanner result in a new laser product? I'm not sure this is the correct forum for this question.... Does incorporating a barcode scanner (that happens to be a class II laser product) into a piece of industrial machinery (e.g., for the purpose of reading identification tags on work pieces) that otherwise does not contain a laser result in a new, reportable laser product under US CDRH requirements? I'm leaning towards 'yes', but I cannot find much guidance on the issue. Regards, Lauren Crane Tokyo Electron - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]<mailto:[email protected]>> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe)<http://www.ieee-pses.org/list.html> List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]<mailto:[email protected]>> Mike Cantwell <[email protected]<mailto:[email protected]>> For policy questions, send mail to: Jim Bacher <[email protected]<mailto:[email protected]>> David Heald <[email protected]<mailto:[email protected]>> - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]>
