Re: Pack of CE Marks?
I don't know from what perspective you are asking the question, BUT, in the final analysis, the only things that count (assuming that the product is covered under one or more of the "New Approach Directives" is: Was the product subjected to the Conformity Assessment procedures prescribed in the applicable Directives AND Does the product meet the "essential requirements" of the applicable Directives Unless you can answer YES to both questions, you are in violation of the law. Regards, Vic Boersma
Re: Power Factor Correction, Medical Equipment?
Although you are correct - neither does the EMC Directive. BUT the EN for harmonics IS in the OJ and it would seem to me to be applicable. Any one else agree??
Temperature Test Equipment
Hello All, I'm looking for any recommendations or advice about temperature test equipment. Currently we use a digital temperature indicator, which gives us a print out, but we still have to copy this information by hand to a data sheet. Since we are preparing to perform a significant amount of temperature tests in the next year, it would be nice if we could electronically transfer the data to our PC via the RS232 ports. What would we need to do this (software, hardware)? Is anyone else doing something similar? Any advice or recommendations will be greatly appreciated. Ron K.
Medical Device Approvals
I am writing a series of articles for Compliance Engineering on the approval of medical devices and need information. I have what I need on UL 544, IEC 601, etc and on EMC issues. What I am looking for is information, including war stories, on FDA approvals and proving safety and effectiveness in the context of a 510k or PMA process. I am also looking for information on approvals in Europe. I have what I need on the MDD, but would like sources for guidance documents, lists of notified bodies, information on sectoral or approval groups and publications in Europe dealing with the subject. Information on current process (i.e pre-MDD) is also appreciated. Finally the identity of newsgroups and mailing lists on the subject is also appreciated. Glen Dash
Re: Semi-anechoic room
Cem, I would reccomend: CIR Enterprises, Inc., Northglenn, CO. (303) 252-9660, Contact: Anthony C. (The owner of the company) Our division bought a used chamber from them recently. We were impressed by both the service and the price. Dan Levin Hewlett-Packard Bioscience Products __ Reply Separator _ Subject: Semi-anechoic room Author: Non-HP-owner-emc-pstc (owner-emc-p...@majordomo.ieee.org) at HP-PaloAlto,mimegw3 List-Post: emc-pstc@listserv.ieee.org Date:5/31/96 8:06 AM Does anybody know the price of 10x10x10m semi-anechoic room(that may be @ with carbon foam or ferrite lines), and which companies sell and y establish that room? Cem KURAL R&D Engineer ARCELIK A.S. E-MAYL: ku...@arcelik.com.tr fax: 90-216 423 30 45
Semi-anechoic room
Does anybody know the price of 10x10x10m semi-anechoic room(that may be with carbon foam or ferrite lines), and which companies sell and establish that room? Cem KURAL R&D Engineer ARCELIK A.S. E-MAÝL: ku...@arcelik.com.tr fax: 90-216 423 30 45
Pack of CE Marks?
G'day folk. Following on from recent postings on 'Systems', and in order to muddy the waters a bit, I'll bring up the subject of 'Excluded Installations'. If you buy a computer, or a machine, that is comprised of a plurality of parts, each CE marked, assembled by a manufacturer for a particular function, then that would seem to be a system, and should be tested and certificated as such. If, however, you procure those self same parts, each CE marked, and assemble them at the place where it is to be used, it comprises an Installation, which need not be tested and certified as a whole, but nevertheless needs to conform to the Protection Requirements. I would ask the groups opinion on the following If I assemble a machine/apparatus from a group of CE marked components, strip it, ship it, rebuild it in the customers plant in exactly the same form as it was originally assembled at source, is this a 'System', or an 'Excluded Installation'? The CE marking requirements are dealt with, i.e. customs see separate boxes each with CE marks. EMC Conformance is dealt with as we would have added ferrites etc. as required to get the Emissions etc. under control. But do we need to test, certificate and CE mark the whole set of equipment as a single entity, or simply show a bundle of component part CE certificates? What say you all? Chris Dupres EMC Specialist. VG Microtech. cdup...@vacgen.fisons.co.uk tel +44 (0) 1825 761077 fax +44 (0) 1825 768343 'Opinions expressed are personal, not necessarily Corporate'
PTT regulation of Spain
Good morning everyone ? Is there anyone can tell me the regulation number of Spanish PTT, electric and acoustic.I got the old one, numbers are royal decree 1376/1989(electric) and royal decree 1376/1989(acoustic).If there are new version of above regulations, please let me know.THANK YOU ! chan lee l...@sam.sam.co.kr Courtesy of RCIC http://uc.com/compliance_engineering/
