Michael, I've been working with CE in the semiconductor industry for about 3 years. Here are some things to look out for.
Self declaration to the Machinery Directive is not very complicated. Make sure your client has a response to every one of the essential requirements of Annex 1. It would be best if they had a relevant standard or section of a standard for their equipment as it relates to an annex 1 issue. i.e. electrical, lasers, radiation, ventilation, acoustical noise....This affords them a much more defendable presumption of compliance to the MD. It is best practice, however, in the declaration of conformity, to only claim compliance to a standard if you comply to ALL of the standard. If they only comply to select sections, the words in the declaration should indicate this. Self declaration to the LVD is also a fair route to take. However, since there is a much more generalized list of essential requirements in the LVD, there seems to be more pressure to comply to a particular standard. If their equipment does fall in the scope of an existing EN standard, especially one that is listed in the official journal of the European commission as being applicable to the LVD, they have little excuse for not using it,.....in full. One not-so obvious quirk of the LVD is that it requires that its supporting information (Technical Documentation in the language of the LVD) be kept on European soil. This responsibility falls to who ever the importer of record is. Self declaration to the EMC directive is nearly impossible unless your client is able to do the required testing themselves exactly as spelled out in the relevant standards. This usually requires a lot of sophisticated equipment and technique. A competent body along with a third party test lab are the best way to go, especially for large or unusual equipment (i.e. NOT a tv, radio, computer, etc...). The equipment you're talking about does sound unusual. Remember each of these directives has a different name for the technical information. MD=technical file, LVD=technical documentation, EMCD=technical construction file. I think it is reasonable to put it all in one file with an appropriate table of contents explaining which bits support which directive. Surf around the European commission web sights concerning hazardous materials. I know there is a hazardous preparations directive and hazardous materials directive. Also watch out for the simple pressure vessel directive for pressurized systems in equipment. You might try giving the NY branch of the commission a call. It would be easiest if your client did not actually supply the hazmat to Europe, but left it up to their customer to acquire the hazmat for use in the equipment. Cheers, Lauren Crane [email protected] > -----Original Message----- > From: Michael Garretson [SMTP:[email protected]] > Sent: Monday, October 05, 1998 7:18 PM > To: [email protected] > Subject: CE Approval of equipment utilizing HPMs > > I am forwarding this question on behalf of one of our clients. Please > forgive the lack of detail in some areas. CE marking is not within > the > normal scope of my responsibilities, so my awareness of the specific > requirements is not great. I would appreciate clarification of some > of > these issues so that we can provide the information to my client in > the > early stages of their design evaluation. It is my understanding that > they > are working with a US-based lab for portions of this work, but are not > confident that they are being provided with accurate information > regarding > what requirements may exist to achieve CE marking of the equipment. > > My company is working with a manufacturer that is intending to send a > piece > of equipment to Ireland for the first time. The equipment is intended > to be > installed in a non-classified location, however it uses flammable > liquid > (hazardous) process chemicals (details unavailable at this time). I > am > under the impression that the manufacturer plans to assemble a > Technical > Construction File in order to demonstrate conformance with the > applicable > requirements of the pertinent CE directives. > > At this time, they intend to demonstrate compliance with the > applicable > portions of the Low Voltage, Machinery and EMC directives. Due to the > hazardous chemical issues, it has also been suggested that conformance > with > 94/009 EEC may be required. > > I would appreciate it if anyone can provide me with guidance on > whether this > approach is reasonable or whether alternatives need to be pursued. > Also if > there are specific pitfalls that this manufacturer may encounter, > please > indicate where those may be, as well. > > If you require additional detail in order to assist my client with > this > matter, please let me know what information you require and I will > pass the > request on to my client. > > Michael Garretson > Sr. Compliance Engineer > Electro-Test, Inc. > +1 503 653 6781 voice > +1 503 659 9733 fax > mailto:[email protected] > > > --------- > This message is coming from the emc-pstc discussion list. > To cancel your subscription, send mail to [email protected] > with the single line: "unsubscribe emc-pstc" (without the > quotes). 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