Here's a repeat of my earlier message on the technical file and other records that a manufacturer should develop and maintain to show compliance to the EU requirements. Any technical reports developed by the manufacturer should contain enough detail to fully reproduce the same results if the tests were to be repeated sometime in the future. Using the established format of well known test houses (including UL, CSA, VDE or NEMKO) would be appropriate for the safety reports.
From: "Peter E. Perkins", INTERNET:[email protected] TO: PSNetwork, INTERNET:[email protected] DATE: 2/6/96 2:06 PM RE: MDoC - technical file PSNet The technical file contains the information that the manufacturer has that provides the basis for the Manufacturer's Declaration of Conformity. This is more than the technical reports that show compliance to the technical standards claimed. Since the tf is the basis for the manufacturer's defense, I usually encourage the development of a complete package of information to support the MDoC. For most companies the data is not collected in one place, but is available thru the company records system. In that case, it is best to develop a list of supporting documents -along with their records tags for future recovery. Here is a typical list organized in a form that a project engineer would use (and sign) to assure management - and the ultimate signer of the MDoC - that there is sufficient information to support the Declaration. I expect that a copy of this tf/toc would be supplied to your European signer/distributor/contact so that they can specifically order the applicable documents when a question arises. Technical File Table of Contents Document control #: Model #: 1Z2Y3W Product description: portable sloosher The following are the technical file documents for this product that are the basis for the CE marking applied to the product. 1) Manufacturer's Declaration of Conformity p/n: rev: 2) Critical drawings and specifications; list attached 3) Engineering considerations for safety & certifications: engineering notebook ref: engineering report ref: 4) Instruction manual (operator, installation & service) p/n: 5) Product safety report: UL Report # to UL 1950 'Safety of It Eq' dated: TuV Report # to EN 60950 'Safety of IT Eq' dated: 6) EMC Reports: Emissions: EMC Report # to EN 55022 'Radiation from IT Eq' dated: Susceptibility: EMC Report to # EN 58001-1 'Generic Emissions,Res/Comml/LiteInd' dated: including: EN 61000-4-2 ESD EN 61000-4-3 Rad'td E field EN 61000-4-4 Fast Transient etc ... 7) Manufacturing control of these essential features is maintained thru the control system described in the Company Quality Document # dated: This product complies with the essential requirements of all applicable EU Directives as listed on the MDoC and is acceptable for CE marking. Project Manager: Date: Project Engineer: Date: All of the documents mentioned must be controlled to the degree that they can be found anytime thru the 10 year period following the end of manufacturing of the product. I recommend that all of them be controlled documents.
