Jim, My two cents... 1. Beams higher than class I can emit from your products aperture but appropriate protections must otherwise be in place. Maintaining class I is ideal, but consider things like laser cutters which must emit higher power beams. A fundamental criterion is that the emitted beam be no higher than what is needed to do what the product is intended to do.
2. While EN 60825-1 not and CDRH standard, several laser notices accept parts of it. It contains the explicit idea that some aspects of product classification can be achieved through inspection (e.g. such as demonstrating no beam exits your product). However if you are counting on attenuation rather than blocking, with a Class II beam source you are probably going to have to measure to demonstrate compliance to class I levels. 3. Safety interlocks are only required in certain circumstances - check the laser standard 21CFR1040.10. It, in fact, allows for the possibility (in some cases) of a non-interlocked protective housing. 4. There are several more administrative obligations, such as submitting an initial product report and any relevant supplemental reports . Be sure to review all of 21CFR subpart J (e.g., part 1000, 1002. Etc...). Regards, Lauren Crane From: Jim Hulbert <[email protected]> Sent: Tuesday, October 23, 2018 3:16 PM To: [email protected] Subject: [PSES] Laser Safety Hi. I would like to confirm laser safety requirements in an industrial machine under the U.S. FDA regulations. If a Class II laser module (purchased OEM) is installed in an industrial type machine, my understanding is that the machine manufacturer must adhere to the following requirements: 1. The machine must provide additional enclosure for the device so that the operator is not exposed to levels higher than Class I during machine operation. 2. The machine manufacturer would be obligated to test the machine to confirm that the Class I levels are indeed not exceeded and submit a report to the FDA. 3. If the additional enclosure for the device can be opened or removed by the operator, the enclosure must be safety interlocked. 4. The machine manufacturer would be required to keep records and report unit sales to the FDA on an annual basis. Is my understanding of the 4 points above correct? If so, am I missing any else? Thanks. Jim Hulbert This email message may contain confidential, proprietary and/or privileged information. It is intended only for the use of the intended recipient(s). If you have received it in error, please immediately advise the sender by reply email and then delete this message. No one other than the intended recipient may disclose, copy, distribute or use the information contained in this message. - ---------------------------------------------------------------- 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]>
