"I don't see any hint of a EU directive just the CE mark but without reference to directives. It could simply mean that they have RoHS. "
The current RoHS is not a CE marking directive. The newly published one will be, but it hasn't taken legal effect yet. This does not, of course, answer your laser question. John C _____ From: McInturff, Gary [mailto:[email protected]] Sent: 26 January 2012 23:56 To: [email protected] Subject: [PSES] I'm at a loss on lasers Does anybody have a succinct answer to the relationship between the FDA and safety approvals? The FDA just seems to classify the maximum out of a laser component, and quite often is class III - and identifies it as harmful to the eye. If I use the device in a product then we have to be concerned with safety approvals of the requisite standard and they require class I output if the beam comes out of the enclosure. The FDA doesn't care about product standards other than medical standards. UL will recognize a laser, imposing fault requirements that the FDA doesn't seem to impose, and will do an EN60825 evaluation as well. They do this with the help of the CDRH report filed with the FDA. Again they will classify the laser in alignment with the CDRH report, but the still apply the end product beam requirements. The FDA seems to care about classification and tracking of the device but not implementation. If class III is hazardous how does one make a gun sight laser for the commercial market without violating in the US or EU directives. I see a package marking that has the CE mark, but who can tell what that means without the DoC - could just be RoHS as far as I can tell. Trying to get the program manager off my back - he's hell bent for leather - charging head because he found the gun sight on the market and that's enough for him. I don't actually blame him, but I need to understand the details a bit more than that. I think I might be wrapped around the axel a little too tightly - the world is full of inherently dangerous things - guns and knives. Should I just be recommending that we grab any only FDA classified laser, put it in the product and sell it hither and yon, like a gun or a knife without product standards. How about the EU - just how does that work - I don't see any hint of a EU directive just the CE mark but without reference to directives. It could simply mean that they have RoHS. Scans of the CDRH report requirements itself are helpful but don't address the relationship between FDA classification and safety control Crud Gary McInturff Reliability/Compliance Engineer Esterline Interface Technologies Featuring ADVANCED INPUT, MEMTRON, and LRE MEDICAL products 600 W. Wilbur Avenue Coeur d'Alene, ID 83815-9496 Office:208-635-8306 Cell: 509 868 2279 Toll Free: 800-444-5923 X 1238 [email protected] <mailto:[email protected]> <http://www.esterline.com/advancedinput> www.esterline.com/interfacetechnologies Technology, Innovation, Performance... - ---------------------------------------------------------------- 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://listserv.ieee.org/request/user-guide.html 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]> - ---------------------------------------------------------------- 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://listserv.ieee.org/request/user-guide.html 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]>
