A small addition to Nick's excellent summary of the Routes to Compliance: The TCF route can also be used when Harmonised Standards exist, but the manufacturer chooses not to (or can't) use all (or any) of them.
Cheers, -------------------------------------------------------------------------------------------- Carlos A J Perkins Compliance Manager MEI Eskdale Rd. Winnersh Triangle Wokingham, Berks, RG41 5AQ UK Mobile: 07818 456961 Tel : +44 (0) 118-944-6461 Fax : +44 (0) 118-944-6412 Email : [email protected] www.meiglobal.com --------------------------------------------------------------------------------------------- Please respond to Nick Williams <[email protected]> To: [email protected] cc: (bcc: Carlos A. Perkins/WIN/Effem) From: Nick Williams <[email protected]> on 02/03/2000 11:58 Subject: Re: Technical Construction File There seems to be come confusion on the matter of technical files and technical construction files, and referring to the text of the CE mark directives, it's not difficult to see why since there is no consistency in the way in which the terms are used. My understanding is as follows. 1.With the exception of the EMC Directive, all CE mark directives require the Responsible Person to compile a file of documentation which demonstrates how the manufacturer justifies their claim of compliance with the requirements of the relevant directive. 2. This collection of documentation is known variously as a Technical File or a Technical Construction File. Except in the EMC Directive, these terms seem to be used interchangeably to mean the same thing. 3. There is no provision in any directive to require that the information relevant to compliance with one directive need be kept separate from that for any other and therefore in most cases a combined technical file which covers compliance with all directives (and lots of other information) makes sense from an organisational point of view. 4. Under the EMC Directive, a manufacturer has three options for compliance. These are the Standards route, the Technical Construction File route and the Type Approval route. 5. Under the Standards route, the manufacturer simply claims compliance with the requirements of the relevant harmonised standards, and thus with the requirements of the directives. While he would, in most cases, be foolish to do this without having some documentary evidence that tests have been completed and passed, this is not mandated under the Directive. 6. Under the Type Approval route, the manufacturer gives the product to a suitably qualified test house who test it and issue a certificate of compliance. This method of complying with the directive is primarily intended for communications (transmitting) apparatus and therefore the new R&TTE Directive will have a major bearing on much equipment which has formerly followed this route. 7. The Technical Construction File (TCF) route to compliance with the EMC Directive is intended for use in those situations where the other two routes do not apply. This will be either because the apparatus is not transmitting apparatus, or because there are no appropriate harmonised standards. 8. Under the TCF route, the manufacturer creates a justification for a claim of compliance with the requirements of the EMC Directive based on such factors as the location and use of the equipment, the results of any tests which have been done and the requirements of any standards which are relevant, if only in part. 9. The key point about the EMC directive's TCF is that for it to be used as the basis of CE marking a product, the file must be submitted to a Competent Body (a term defined in the directive and distinct from a Notified Body) who must examine it and agree to the logic used to justify the claim of compliance. Thus, the TCF route to complying with the EMC directive is NOT a self-certification process. 10. To cloud the matter even further, there is a (complicated) provision within the Machinery Directive which allows for a manufacturer to involve a notified body in the creation and storage of the Technical File for certain machinery. This really only has relevance in the context of annex IV machines which require type approval (etc.). I don't know of any situation where such a provision has been applied, and it's a mystery to me and to several other people I have spoken to about this subject as to quite what the Commssion was thinking when it drafted this section of the directive. As I mentioned at the beginning, the EC have done us no favours in being muddled about the terminology they apply in the different directives, but it is important to understand that the TCF specified under the EMC Directive has a quite distinct and different legal status to the technical documentation requirements of the other directives. Hope that helps! Nick. ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: [email protected] Michael Garretson: [email protected] For policy questions, send mail to: Richard Nute: [email protected] ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: [email protected] Michael Garretson: [email protected] For policy questions, send mail to: Richard Nute: [email protected]
