I agree with Lauren - even if the embedded laser meets the appropriate CDRH requirements for the Class of laser, the end product you sell with the embedded laser is now a Class 1 laser product. CDRH initial and annual reporting is required, as is proper labels and limiting access to the embedded laser. I have a client with products with embedded Class 4 lasers and I have found the laser manufacturer has been very helpful in providing some information needed.Hope this helpz.Stay healthy, stay safe.Sent from my Verizon, Samsung Galaxy smartphone -------- Original message --------From: [email protected] Date: 5/20/20 11:26 AM (GMT-05:00) To: [email protected] Subject: Re: [PSES] 21 CFR § 1040.10 - Laser products.
Hi Amund, I think I disagree. If you are incorporating some other manufacturer’s laser into your product, generally speaking, you are making a new laser product which must be assessed for conformance to 1040.10 (and reported etc…). The main role of the section you cited is to allow one manufacturer to sell a laser to another manufacturer without it having to be assessed (and certified). Incorporating a laser component that is already certified can give you some confidence that whatever is going on inside the component was done correctly (although you are still responsible for it as a manufacturer), but it does not relieve you of your responsibilities for your own product. A couple ‘newbie’ tips – watch out for the meaning of ‘certified’ – it has nothing to do with e.g. UL in this context, and since your device is a measurement device, be sure to take a look at 1040.11 also. Best Regards, -Lauren From: Amund Westin <[email protected]> Sent: Wednesday, May 20, 2020 12:50 AM To: TEH EHS Crane, Lauren <[email protected]>; [email protected] Subject: SV: [PSES] 21 CFR § 1040.10 - Laser products. Thanks Lauren The final product is a kind of industrial measurement device and it contains a laser device which is bought from an external manufacturer. Right now, I do not have any information about the laser device, but I wonder if this paragraph might be applicable: § 1040.10 Laser products. (a) Applicability. The provisions of this section and § 1040.11, as amended, are applicable as specified to all laser products manufactured or assembled after August 1, 1976, except when: (1) Such a laser product is either sold to a manufacturer of an electronic product for use as a component (or replacement) in such electronic product, I suppose the manufacturer of the final product should not deal with 21 CFR § 1040.10 and instead be aware and purchase laser devices which are ready tested and approved according to this regulation. Agree? Best regards Amund -----Opprinnelig melding----- Fra: [email protected] Sendt: 19. mai 2020 16:26 Til: [email protected] Emne: Re: [PSES] 21 CFR § 1040.10 - Laser products. Hi Amund, It's been a key aspect of my work for several years. It can be quite challenging. Terminology and meaning are a little tricky. The amount of time consumed sort of depends on whether you are dealing with a product that fits nicely 'between the lines'. Regards, -Lauren -----Original Message----- From: Amund Westin <[email protected]> Sent: Tuesday, May 19, 2020 3:17 AM To: [email protected] Subject: [PSES] 21 CFR § 1040.10 - Laser products. Anyone who have been through the process for complying to 21 CFR § 1040.10? Time consuming process? BR Amund - ---------------------------------------------------------------- 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]> - ---------------------------------------------------------------- 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]> - ---------------------------------------------------------------- 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]>
