From: Jeff Whitmire ITS/QS-Atl <[email protected]> Subject: RE: Not Correct Mr. Whitmire List-Post: [email protected] Date: Sun, 15 Dec 1996 14:27:58 -0500
My company has changed Internet services and I am currently having difficulties subscribing to treg again. Unfortunately I have missed all discussion of this topic after 12/13. I am sending this over my own MSN connection. ........................................................................ ................ Mr. Towner. I think you missed the intent stated in the first paragraph of my response. The general discussion was about the application of the EN61000-4 standards. In response to your lengthy comments there are a couple of things we should all keep in mind. - I have assumed that when we subscribe to this media, we understand that this is a general discussion group. The opinions placed on this media should never be taken as complete and legal interpretations. If in doubt one should always read the requirements and make their own interpretations or refer directly to the appropriate Authority. After all, each manufacturer is responsible for the compliance of their own products. The purpose of this forum is to openly discuss issues and interpretations among fellow compliance professionals and try to keep current in the regulatory world. If this a an incorrect assumption, please let me know. - My response was to a general set of discussions that were going around about the EN61000 series of standards. During some parts of the previous discussions, some persons may have assumed that as soon as these standards were published, they would be responsible for compliance to these standards. There were several responses that covered my ideas in bits and pieces. My response was never intended to be a comprehensive explanation of the entire EMC Directive, nor do I believe anyone took it as such. If they did, I apologize. I will address your concerns with my statements individually, with a brief conclusion at the end. You replied---> ---------- >Subject: Re: Not Correct, Mr. Whitmire! >Date: Friday, December 13, 1996 8:00PM >Let's get this straight, Mr. Whitmire, I'm tired of misinformation!! >IT IS NOT A REQUIREMENT OF THE EMC DIRECTIVE TO USE HARMONIZED >STANDARDS, >PRODUCT SPECIFIC STANDARDS, GENERIC STANDARDS, OR ANY OTHER >STANDARDS! IN >FACT, >A MFR. CAN USE MIL STD, OR BELLCORE, OR ANY OTHER STANDARD >HE/SHE WISHES TO >USE, >IF SHE/HE WISHES TO USE STANDARDS AT ALL! I never stated that it was a requirement to use harmonized standards. Alternatives were offered... "unless you are using the TCF route". Many different methods may apply. It was not my intent to go into great detail on any other route to demonstrate a presumption of compliance. If so my response would have been much longer. I agree that If one wants to declare under other standards, or no standards at all they may do so. Typically the easiest method to demonstrate a presumption of compliance is to follow the use of standards published in the official journal. >FURTHERMORE, Under the EMC Directive there are TWO types of standards >(READ >ARTICLE 7 BELOW) in an accepted hierarchy, and these standards don't have >anything to do with product specificity or generic requirements under the >Directive. That information comes from the subdivision of the standards >referred to in Article 7 below by the Official Journal, WHICH IS NOT THE EMC >DIRECTIVE OR ANY OTHER DIRECTIVE, AND DOES NOT OFFER TO >INTERPRET COMPLIANCE >WITH THE DIRECTIVES. >Article 7 of the Directive refers to "harmonized standards", and I quote: >1: Member states shall presume (that's PRESUME, not assert!) compliance with >the >protection requirements referred to in Article 4 in the case of apparatus >which >is in conformity; >a) with the relevant national standards transposing the harmonized standards, >the reference numbers of which have been published in the Official Journal of >the European Communities. Member states shall publish the reference of such >national standards; >b) or with the relevant national standards referred to in paragraph 2 in so >far >as, in the areas covered by such standards, no harmonized standards exist. >2) (Foregone. relevance is not appropriate to this argument) >3) Member States shall accept that where the manufacturer has not applied, or >has applied only in part the standards referred to in paragraph one, or where >no >such standards exist, apparatus shall be regarded as satisfying the protection >requirements has been certified by means of attestation provided for in >Article >10(2); >Article 10: >2) In the case of apparatus for which the manufacturer has not applied, or >has >applied only in part, the standards referred to in Article 7 (1) or failing >such >standards, the manufacturer or his authorized representative shall hold at the >disposal of the relevant competent authorities, as soon as the apparatus is >placed on the market, a technical construction file. This file shall describe >the apparatus, set out the procedures used to ensure conformity of the >apparatus >with the protection requirements referred to in Article 4 and include a >technical report or certificate, one or the other obtained from a competent >body. >etc., etc., etc., > But you say in your statement "to declare conformity to the EMC Directive you >MUST [caps mine] use the product specific standard, or if none is published >use >the Generic Standard for the intended environment..." in reference to the use >of >standards. Standards are an excellent basis against which conformity can be >gauged, and they should be used as such. Indeed, they should be implemented >in >the design phase because that's what they're for. But there is nothing in the >Directive or any amendments that either advocates or mandates the use of >standards. In fact, under article 9 of the Directive the manufacturer bears >some culpability "where the apparatus does not meet the standards referred to >in >article 7... incorrect application of the standards referred to in article >7... >shortcomings in the standards referred to in Article 7 (1) themselves..." In >this case the authorities have already taken the product off the market and >will >keep it off for at least two months while they make up their minds. Either >way, >a manufacturer or supplier is hurt...seriously! >The implication is that a TCF may be a better risk management tool than the >standards route, but article 9 addresses this as well (I'll let you do the >reading. I can't do ALL the work.) I apologize for the use of the work "must". However, the very last words in the paragraph were " unless you are using the TCF route". The general comment was to indicate the route of demonstrating the presumption of compliance through the application of harmonized standards which are published in the Official Journal. >FURTHERMORE, AND MORE IMPORTANTLY, you make inappropriate reference >to the use >of standards other than "harmonized standards" in showing conformity to the >essential requirements of the Directive. It is true that one may use >standards >other than those "harmonized" to show conformity with the essential >requirements >of the Directives, but this is only permissible if a Competent Body is >engaged. >YOUR INFORMATION IS NOT ONLY INCORRECT AND MISLEADING, IT IS >DANGEROUS!! This paragraph was to demonstrate that the published standards, such as the Generic Standards themselves refer to standards other than "harmonized standards". Please read the entire sentence (caps added by me). "A side note. The standards specified in the PRODUCT SPECIFIC or GENERIC STANDARDS do not have to be harmonized or published in the Official Journal in order to be applied to a product." I should have continued with "when applying that generic or product specific standard" This was a statement of fact. These standards themselves apply "other than harmonized standards" to a product to demonstrate the presumption of compliance. I do see that it may be possible to misinterpret this sentence if taken out of the context of the paragraph which included... "Case in point the ENV standards in the Generic Immunity......" This was simply meant to demonstrate that all standards do not have to be published in the official journal in order to be applied to the product. There was never a reference (at least intended) that the individual use of these "other than harmonized standards" was appropriate in any form. >AN ENV CANNOT BE SUBSTITUTED FOR AN EN UNLESS A COMPETENT >BODY OVERSEES THE >SUBSTITUTION! >A standard is only "harmonized" if it is published as "harmonized" in the >Official Journal. Any ENVs are, by definition, UNDER CONSIDERATION, are >thereby >NOT "harmonized" and so cannot be employed to show conformity outside the >jurisdiction of a Competent Body, which could be more expensive, >time-consuming, >and frustrating than re-designing to meet the "harmonized" standards. See the response to the previous paragraph. In addition see paragraph 5 "unless your are using the TCF route" >I appreciate that you are trying to get the information out. But you bear a >certain responsibility in doing that. PLEASE TAKE THE TIME TO BE COMPLETE >IN >YOUR ASSERTIONS AND CONSULT AN EXPERT BEFORE YOU PUT >INFORMATION LIKE THIS AT >THE DISPOSAL OF PEOPLE WHO NEED IT TO PERFORM THIER >RESPONSIBILITIES!!! It is >information like what you have just given that has manufacturers doing loops, >wasting time and effort, and spending tons of money doing the wrong things to >show compliance. >BAD INFORMATION IS UNACCEPTABLE IN REGULATORY COMPLIANCE. THIS >IS NOT A >TRIVIAL >ISSUE! >Please, for the sake of your clients and those of us who appreciate good >information, Bone up!! >Rick Towner >888-2-CE MARK I appreciate your input. I was trying to get some information out quickly without going into a complete discussion of the EMC Directive. I did not realize that my opinion carried such authority that someone would consider it a full legal interpretation of the EMC Directive. I do not sign off my responses with any title, telephone number or company name that might even hint that I am some great authority (which I am not). In the future I will strive to format my responses in a form that they (as much as possible) cannot possibly be misinterpreted. I encourage all to do the same. However, I suspect this will reduce the amount of discussion and responses among the group, due to the amount of time it takes. In the future, If you wish to take issue with a certain statements it is helpful to include the body of that correspondence so that we can all review your points. It is very easy to paraphrase items or evaluate one sentence out of an entire paragraph and misinterpret the intent of the correspondence. Regards to all Jeff (Mr. Whitmire) Whitmire ************************************************************************ ******** ****************** These opinions are my own and not those of my employer. They are in no way shape or form to be considered legal and binding. ************************************************************************ ********
