Paul, Our company has always self certified to EN 60825-1. We did the following:
1. Got ourselves a copy of the standard. My latest price list from Compliance Engineering lists the standard for $177. I'm sure that its also available from other companies such as Conformity Standards, European Document Research, Simcom International, et al. You may even be able to download a copy from the web. The currently harmonized version is EN 60825-1:1994 and Amendment 11:1996. 2. We then calculated the accessible emissions from our product using a worst case scenario and compared it to the Accessible Emissions Limits in EN 60825-1. In order to define the worst case scenario, we have designed protection circuitry into our products so that if the laser circuit fails (single fault), the circuit provides a pre-defined maximum current to the laser diode. Some of our products fall into Class I, others fall into Class II. These calculations are filed in our product's Product Specification Document. As part of our ISO certification, we keep a PSD for each product in Document Control. As an aside, calculating the accessible emissions is not a trivial task. There are quite a few assumptions to be made and quite a bit of solid angle geometry. It's not impossible, but if you don't want to calculate the accessible emissions, check with Sensor Physics Corp. in Florida, they have systems which will measure the accessible emissions from a laser product. I don't have their website handy, but I'm sure that you can find them with a typical web search engine. 3. Once the laser classification is determined, we follow the labeling, interlocking and user's manual requirements listed in EN 60825-1. The standard is "self-contained" in this regard. Once you have determined your laser classification, the standard will spell out all of the safety measures that you need to take. 4. Once we have incorporated the safety measures from EN 60825-1 into our design, we simply include EN 60825-1 on our Declaration of Conformity along with the EMC and product safety standards that the product meets. 5. An added benefit of this is that the European requirements are very similar to the US requirements spelled out in the Code of Federal Regulations (CFR), Title 21, Paragraph 1040. These regulations are enforced by the Center for Devices and Radiolgical Health (CDRH) which is part of the Food and Drug Administration (FDA). Our products that are Class I for EN 60825-1 also fall in the CDRH's Class I definition. The same is true for our Class II products. Within one month of releasing any new products incorporating lasers, we have to file the product with the CDRH. You can download sections of the CFR from www.access.gpo.gov/nara. Hope this helps. Chris Maxwell > -----Original Message----- > From: Lubeski, Paul [SMTP:plube...@hnt.wylelabs.com] > Sent: Tuesday, March 07, 2000 4:53 PM > To: IEEE ORG > Cc: Loop, Robert > Subject: EN60825 > > > All: > > We are looking for information on what the process is for getting a Class > II > laser device approval to EN60825 in Europe. > > Thanks in advance for any information that can be provided. > > > Paul A. Lubeski > Senior Engineer > Wyle Laboratories, Inc. > 7800 HWY 20 W. > Huntsville, AL 35806 > (256) 837-4411 ext. 494 > (256) 830-0904 fax > plube...@hnt.wylelabs.com > > http://www.wylelabs.com > > > ------------------------------------------- > This message is from the IEEE EMC Society Product Safety > Technical Committee emc-pstc discussion list. > > To cancel your subscription, send mail to: > majord...@ieee.org > with the single line: > unsubscribe emc-pstc > > For help, send mail to the list administrators: > Jim Bacher: jim_bac...@mail.monarch.com > Michael Garretson: pstc_ad...@garretson.org > > For policy questions, send mail to: > Richard Nute: ri...@ieee.org > ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson: pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org
