Hello, Since we manufacture medical equipment we are also governed by CISPR 11 (plus others.) This has been an interesting conversation. I have had personal conversation with someone who is on CISPR 11 committee and have received the author's permission to post "his take" on this discussion.
Thanks to all, Dave Garnier From: wayne_hunter @ agilent.com Sent: Friday, October 20, 2006 7:53 AM To: Garnier, David S (GE Healthcare) Subject: RE: FW: classification of a (very) large industrial printer Hi Dave, Well, if we want to determine which came first, the chicken or the egg, CISPR 11 was first published in 1934. It was one of the first CISPR publications. It has been in continuous use since that date. CISPR 22 was first published in 1985. (The first draft document for CISPR 22 was published as Report 7B in 1975.) So, if we look at history, we compare 1934 to 1975, and I will be lenient here and use the report date, and we have CISPR 11 in use as the controlling standard for radiated and conducted emissions within CISPR for over 40 more years than CISPR 22. The scope of CISPR 22 can take precedence, if the manufacturer wishes to use it. Since both CISPR 11 and CISPR 22 are listed as Product Family standards, they are at the same hierarchal level for use by a manufacturer of a product. CISPR 11 (or EN 55011 if you want to use European standards only) is also a published and acceptable standard to use for the demonstration of compliance to the EMC Directive. So, it is up to the manufacturer to determine the applicability of the standard to use for compliance, as long as it is a published standard within the OJ. This brings me to point #2. The statement to use IEC 61000-3-4 and IEC 61000-3-5 for large equipment for harmonics is not acceptable for Europe. In the latest Official Journal, these standards are not published and accepted by the EU as useable for demonstration of compliance to the Directive 89/336/EEC. While they may be IEC standards, they are not adopted by CEN or CENELEC for use within the EU or published within the Official Journal. If you want to check yourself, the official list of published standards for Europe is located at http://www.newapproach.org/Directives/Default.asp . If the standard is not listed here, you must use a Technical Construction File approach for the product to use other unaccepted standards. So, in this case, there are no applicable standards for the product for harmonics and the only requirement is to not create interference to other products. Doing a search on IEC 60690 on the IEC web draws a blank. At this time, the only applicable standards for IVD devices is either the Medical EMC standard of IEC/EN 60601-1-2 or you may choose to select either EN 55011 or EN 55022 since the IVD directive missed the EMC standards during the last OJ publication. This is being corrected in December, but at this time, IVD do not have an established set of EMC standards. Then, using EN 50081, depending on whether you select EN 50081-1 or EN 50081-2 you can select either CISPR 11 or CISPR 22. Again, since both are published standards in the OJ, it is the discretion of the manufacturer to select the appropriate standard for their products. Back in the days when Agilent was HP, we took this to the EU court for an interpretation because we were using EN 50081-2 for emissions and EN 50082-1 for immunity to demonstrate compliance. A certain regulatory official did not agree with that selection. The official ruling from the EU court was that it was up to the manufacturer to select the appropriate standards from the published list for their products. It was up to the regulatory officials to prove that the selection did not meet the required protection of the Directive. The official could not prove their case and it was ruled in favor of HP. So, use of CISPR 11 or CISPR 22 (or if you prefer EN 55011 or EN 55022) is at the discretion of the manufacturer based upon intended use of the product. Under the new Directive that will come into force in July 2007, this becomes even clearer. To cite the new Directive 2004/108/EEC, (16) The conformity assessment obligation should require the manufacturer to perform an electromagnetic compatibility assessment of apparatus, based on relevant phenomena, in order to determine whether or not it meets the protection requirements under this Directive. (17) Where apparatus is capable of taking different configurations, the electromagnetic compatibility assessment should confirm whether the apparatus meets the protection requirements in the configurations foreseeable by the manufacturer as representative of normal use in the intended applications; in such cases it should be sufficient to perform an assessment on the basis of the configuration most likely to cause maximum disturbance and the configuration most susceptible to disturbance. Please not the use of the words, "in the configurations foreseeable by the manufacturer as representative of normal use in the intended applications;". This is a compromise that was accepted by the European Commission to provide protection to the manufacturer in case of misuse of equipment or standards by regulators or consumers. This was a hard fought victory for the manufacturers and required over 4 years of negotiation. and in Chapter 2, Article 9 you will find the new Directive provides for the use of relaxations in Clause 5 5. The information required to enable apparatus to be used in accordance with the intended purpose of the apparatus shall be contained in the instructions accompanying the apparatus. There is also a provision under the new Directive allowing the use of the Technical Construction File certification without the use of external review per section 15 of the forward stating: (15) It should be possible to place apparatus on the market or put it into service only if the manufacturers concerned have established that such apparatus has been designed and manufactured in conformity with the requirements of this Directive. Apparatus placed on the market should bear the 'CE' marking attesting to compliance with this Directive. Although conformity assessment should be the responsibility of the manufacturer, without any need to involve an independent conformity assessment body, manufacturers should be free to use the services of such a body. Nowhere does it state that because a product uses the name "printer" that it is applicable to CISPR 22 testing. Many of the Super Computers also certify to CISPR 11 because CISPR 22 test distances for radiated emissions place the product into the near field for radiated emissions and create too restrictive a test environment. While some groups do not agree with this interpretation, it has been validated in the courts and is applicable to all products. So, it is up to the manufacturer to specify how and which standards are applicable from the list of published standards. It does not state which standards you must use and does not specify that you must use EN 50082-1 if you use EN 50081-1 or vice versa. You are free to select the appropriate standards for the product. If you reference EN 50081-2 for emissions of Industrial Products (or IEC 61000-6-4 of which I am a member of the WG drafting this standard) you will note that it includes CISPR 11 and CISPR 22. So, CISPR 11 can be appropriate for this product as it is stated to be an industrial product. While other people have other opinions, this one has been tested through the courts. Regards, Wayne - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to [email protected] Instructions: http://listserv.ieee.org/request/user-guide.html 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] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc ______________________________________________________________________ This email has been scanned by the MessageLabs Email Security System. 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