Ce technical file sample4/28/2023 ![]() ![]() ![]() Quality control & commissioning procedures.Copy of instructions (user, maintenance, installation).Description of control philosophy/logic.Records of risk assessments and assessments to standards.Description of the apparatus, usually accompanied by a block diagram.As a general guide, the following items should be included: The directives contain clauses which give some general details of the kind of information which will be required in the technical file, but this is couched in the most general of terms. Waste Electrical and Electronic Equipment (WEEE) DirectiveĪll CE marking directives require the manufacturer of the product to create a technical file which should contain the information required to show that the product properly complies with the requirements of the directives which apply to it.Transportable Pressure Equipment Directive.Personal Protective Equipment Regulation.Non-road Mobile Machinery Exhaust Emissions Directive.Noise Emission of Outdoor Equipment Directive.In-Vitro Diagnostic Medical Devices Directive.Automotive Electromagnetic Compatibility Directive.Active Implantable Medical Devices Directive.Restriction of Hazardous Substances (RoHS) Directive.Electromagnetic Compatibility (EMC) Directive.10 Things you should know about CE Marking.Comparison of CE Marking and UKCA Marking.Product Safety and CE Marking Assessment. ![]()
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