Hmmm it does exist, however their definition I suspect is somewhat inappropriate.
I guess if you consider self-declaration a form of certification, then yes I would agree with you. Too bad OSHA and other globally recognized bodies do not accept products that I deem “CERTIFIED” an acceptable means of diligence. They usually will only accept “official documents”. Typically through an accredited laboratory or certified body. It is possible that I am just bad at convincing the authorities that when I say my products are certified they need to take me at my word. cer·ti·fi·ca·tion the action or process of providing someone or something with an “official document” attesting to a status or level of achievement. Thank you. From: lauren.cr...@us.tel.com [mailto:lauren.cr...@us.tel.com] Sent: Tuesday, October 09, 2018 10:51 AM To: Schmidt, Mark; EMC-PSTC@LISTSERV.IEEE.ORG Subject: RE: Does incorporated barcode scanner result in a new laser product? Just FYI regarding “certified”. A Laser is a type of Electronic Product under 21CFR. All Electronic Products for which there is an applicable standard in 21CFR subpart J (such as lasers) must be certified. This is essentially an act of self-declaration. TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER J--RADIOLOGICAL HEALTH PART 1010 -- PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL Subpart A--General Provisions Sec. 1010.2 Certification. (a) Every manufacturer of an electronic product for which an applicable standard is in effect under this subchapter shall furnish to the dealer or distributor, at the time of delivery of such product, the certification that such product conforms to all applicable standards under this subchapter. (b) The certification shall be in the form of a label or tag permanently affixed to or inscribed on such product so as to be legible and readily accessible to view when the product is fully assembled for use, unless the applicable standard prescribes some other manner of certification. All such labels or tags shall be in the English language. (c) Such certification shall be based upon a test, in accordance with the standard, of the individual article to which it is attached or upon a testing program which is in accordance with good manufacturing practices. The Director, Center for Devices and Radiological Health may disapprove such a testing program on the grounds that it does not assure the adequacy of safeguards against hazardous electronic product radiation or that it does not assure that electronic products comply with the standards prescribed under this subchapter. (d) In the case of products for which it is not feasible to certify in accordance with paragraph (b) of this section, upon application by the manufacturer, the Director, Center for Devices and Radiological Health may approve an alternate means by which such certification may be provided. From: Schmidt, Mark <markschm...@xrite.com> Sent: Tuesday, October 09, 2018 8:35 AM To: TEH EHS Crane, Lauren <lauren.cr...@us.tel.com>; EMC-PSTC@LISTSERV.IEEE.ORG Subject: RE: Does incorporated barcode scanner result in a new laser product? It’s been a while since I had to deal with this stuff but ask the manufacturer for the CDRH Accession Number, then conduct a search for it to assure its validity. This typically means that all the proper steps and paperwork were filed with the CDRH by the original manufacturer. It does not mean its compliant or approved through the CDRH, just that the claims and appropriate reports/data has been submitted to the CDRH. The CDRH accession number just indicates that they received the data that the manufacturer submitted. It is basically the laser manufacturer attestation that the claims made are in good faith based on this submitted data. So, if you are not modifying anything and just using the laser as is, you are minimizing risk based on original manufacturer data. A diligent/reputable manufacturer should have a report that they are willing to share or minimally the calculation they made to classify the laser based on IEC60825-1. The CDRH and IEC have similar classifications. The laser manufacturer should also be auditing the output power on these devices you could ask them for their audit procedure for this (a requirement of 21CFR1040.10/11 . Proper labelling on the device is also critical along with your warning/caution statement in the manual. The word “certified” does not exist in the CDRH laser world (that I am aware of). Be very careful of your laser selection there is a lot of deception out there and many third party labs/NRTL’s will want (require) to test before they List the main device incorporating the laser in question. Unless of course you have worked with your reputable laser manufacturer and supplied the NRTL with the appropriate documents providing the required evidence that the laser in question has validity and is appropriately classified. If not be prepared to add time and money to your program for addition testing. Mark From: Lauren Crane [mailto:lauren.cr...@us.tel.com] Sent: Monday, October 08, 2018 4:04 PM To: EMC-PSTC@LISTSERV.IEEE.ORG<mailto:EMC-PSTC@LISTSERV.IEEE.ORG> Subject: Re: [PSES] Does incorporated barcode scanner result in a new laser product? I’ve gotten some direct replies such that I think some additional perspective might be helpful. Correct application of the US laser regs requires some significant attention to fine points. Particularly in light of certified* laser products available ‘off the shelf’ that are incorporated into another product to form a new laser product. In addition to the laser ‘standard’ (21CFR1040.10/11) there have been many Laser Notices published by FDA/CDRH that provide what are effectively exemptions (scenarios to which they “will not object”). There are particularly many reliefs for inherently Class I laser products (which may contain higher classes of embedded lasers) which are themselves then embedded in another product. Consider the Class III laser in a Class I DVD drive incorporated into a computer – (which itself is interpreted as an non-classified laser product, but not completely out of scope since some of the administrative obligations remain). So the case I am puzzling over is an appropriately certified* Class II laser product (the scanner), essentially being bundled with an industrial machine, but otherwise not modified. As I’ve said, my first reaction is that a new laser product is being manufactured…. But perhaps there are some, for example, laser notice fine points I am not recalling. *certified in this context means self-declared as compliant to the US Federal Laser ‘Standard’… it is not related to any sort of electrical safety certifications. So if anyone has walked this road before, thanks in advance for thoughts and guidance, particularly if you think I’ve got it wrong. Regards, Lauren Crane Tokyo Electron From: Nyffenegger, Dave <dave.nyffeneg...@bhemail.com<mailto:dave.nyffeneg...@bhemail.com>> Sent: Monday, October 08, 2018 12:08 PM To: TEH EHS Crane, Lauren <lauren.cr...@us.tel.com<mailto:lauren.cr...@us.tel.com>>; EMC-PSTC@LISTSERV.IEEE.ORG<mailto:EMC-PSTC@LISTSERV.IEEE.ORG> Subject: RE: Does incorporated barcode scanner result in a new laser product? 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:lauren.cr...@us.tel.com] Sent: Monday, October 08, 2018 11:49 AM To: EMC-PSTC@LISTSERV.IEEE.ORG<mailto:EMC-PSTC@LISTSERV.IEEE.ORG> 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. 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